PREHAB: Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.

• Sponsor: St. Boniface Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02219815
• Collaborator: (none)
• Enrollment: 89
• Locations: 5
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 17.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based cardiac rehabilitation facility. Patients can wait for elective heart surgery for as long as 3-4 months. During this time, individuals are often fearful of making things worse, causing them to stop being active and further deteriorate their physical condition. This wait period presents a potential opportunity for health care providers to engage the patient to take control of their self-managed care prior to surgery with the intent of improving post-surgical outcomes. Patients randomized to the PREHAB intervention group will participate in supervised exercise twice per week in a program designed to improve physical functioning and exercise capacity. The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and improve overall quality of life.

Condition or Disease	Intervention/Treatment	Phase
Patients Waiting for Elective Isolated Coronary Artery Bypass Grafting (CABG); Patients Waiting for Aortic Valve Repair/Replacement for Moderate Aortic Stenosis or Severe Regurgitation; Patients Waiting for Mitral Valve Repair/Replacement for Moderate Stenosis or Severe Regurgitation; Patients Waiting for Combined Procedures. (CAGB and Valve)	Behavioral: Prehab Intervention	N/A

Detailed Description

PREHAB will be a three centre prospective, randomized, open, blinded endpoint (PROBE) controlled trial using assessor blinding and intention-to-treat analysis. The study will be conducted at three academic, tertiary care hospitals (St. Boniface Hospital, Winnipeg, MB, Montreal Heart Institute. Montreal QC and Queen Elizabeth II Health Sciences Centre, Halifax, NS) and one non-academic hospital (Saint John Regional Health Centre, Saint John, NB) that perform cardiac surgery. These sites were chosen based on similar patient populations and surgical waitlist times. Additionally, each of these sites are partnered with one or more community-based cardiac rehabilitation (CR) centres, which are certified medical fitness facilities dedicated to improving the health of the community through health promotion, disease prevention and rehabilitation services. These facilities offer expert guidance from certified professionals, innovative health enhancement programs, and provide integrated medical, rehabilitative and fitness services. The investigators intend to recruit a total of 244 participants to the study (122 per study arm), anticipating a 20% dropout rate to achieve an eventual sample size of 194 participants.

Patients in the PREHAB group will receive, in addition to standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. This program will target both the physical and psycho-social-cognitive aspects of cardiac disease and frailty. In brief, participants will be required to complete an intake health status assessment by the CR team including a physiotherapist, cardiovascular nurse, and dietitian and complete a symptom-limited graded exercise stress test according to the American College of Sports Medicine Guidelines for Exercise Testing and Prescription 7th Edition. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. This has been shown to be safe and effective in unrepaired heart failure and elderly patients. PREHAB participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Care Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).
Experimental: Prehab Intervention Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.	Behavioral: Prehab Intervention; Pre-operative, structured exercise intervention.

Outcome Measures

Primary Outcome Measures

1. Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. [Post-surgery (approximately 9 weeks after baseline)]

   Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days

Secondary Outcome Measures

1. Baseline Exercise Capacity [baseline assessment - Study entry]

   This measure will be assessed using the results of a 6 minute walk test.

2. Preoperative Exercise Capacity [Pre-Surgery (approximately 8 weeks after baseline)]

   This measure will be assessed using the results of a 6 minute walk test.

3. 3-Month Exercise Capacity [3 Months Post-Surgery (approximately 5 months after baseline)]

   This measure will be assessed using the results of a 6 minute walk test.

4. 1-Year Exercise Capacity [1 Year Post-Surgery (approximately 14 months after baseline)]

   This measure will be assessed using the results of a 6 minute walk test.

5. Baseline Physical Activity Behaviour [baseline assessment - Study entry]

   This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

6. Preoperative Physical Activity Behaviour [Pre-Surgery (approximately 8 weeks after baseline)]

   This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

7. 3-Month Physical Activity Behaviour [3 Months Post-Surgery (approximately 5 months after baseline)]

   This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

8. 1-Year Physical Activity Behaviour [1 Year Post-Surgery (approximately 14 months after baseline)]

   This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

9. Baseline Health-Related Quality of Life [baseline assessment - Study entry]

   This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

10. Preoperatve Health-Related Quality of Life [Pre-Surgery (approximately 8 weeks after baseline)]

    This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

11. 3-Month Health-Related Quality of Life [3 Months Post-Surgery (approximately 5 months after baseline)]

    This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

12. 1-Year Health-Related Quality of Life [1 Year Post-Surgery (approximately 14 months after baseline)]

    This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

13. Baseline Frailty [baseline assessment - Study entry]

    This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

14. Preoperative Frailty [Pre-Surgery (approximately 8 weeks after baseline)]

    This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

15. 3-Month Frailty [3 Months Post-Surgery (approximately 5 months after baseline)]

    This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

16. 1-Year Frailty [1 Year Post-Surgery (approximately 14 months after baseline)]

    This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

17. Baseline Anxiety [Baseline Assessment - Study entry]

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

18. Preoperative Anxiety [Pre-Surgery Assessment (approximately 8 weeks after baseline)]

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

19. 3-Month Anxiety [3 Months Post-Surgery (approximately 5 months after baseline)]

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

20. 1-Year Anxiety [1 Year Post-Surgery (approximately 14 months after baseline)]

    This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

21. Baseline Depression [Baseline Assessment - Study entry]

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

22. Preoperative Depression [Pre-surgery Assessment ( 8 weeks after baseline)]

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

23. 3-Month Depression [3 Months Post-Surgery (approximately 5 months after baseline)]

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

24. 1 Year Depression [1 year Post-Surgery (approximately 14 months after baseline)]

    This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

25. Postoperative Major Adverse Events [Post-Surgery (approximately 9 weeks after baseline)]

    Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.

26. Postoperative Cardiac Rehabilitation Attendance [Post-Surgery (approximately 20 weeks after baseline)]

    Will be assessed using administrative data from participating cardiac rehabilitation facilities.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged 60 years and older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair/replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures

• Patients with Clinical Frailty Score (CFS) ≥3 (vulnerable) and < 7 (8 = very severely frail, approaching end-of-life or 9 = terminally ill) at time of acceptance for cardiac surgery

• Patients with an estimated ≥ 6 week wait time

Exclusion Criteria:

• Patients who have unstable or recent unstable cardiac syndrome as defined by:

1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms

2. Critical left main (LM) coronary disease

3. Hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome prior to randomization

• Patients who have severe left ventricular obstructive disease as defined by:

1. Severe aortic or mitral stenosis (aortic or mitral valve area <1.0cm2 or mean gradient > 40 mmHg or > 10 mmHg respectively)

2. Dynamic left ventricular (LV) outflow obstruction

• Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias

• Patients who have cognitive deficits that would preclude rehabilitation

• Patients who have physical limitations that would preclude rehabilitation

• Patients who are unable to attend the Prehab program

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Boniface General Hospital	Winnipeg	Manitoba	Canada	R2H2A6
2	Saint John Regional Hospital - New Brunswick Heart Centre	Saint John	New Brunswick	Canada	E2L4L2
3	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H3A7
4	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
5	Laval University	Quebec City	Quebec	Canada	G1V4G5

Sponsors and Collaborators

• St. Boniface Hospital

Investigators

• Principal Investigator: Rakesh Arora, MD, St. Boniface Hospital/University of Manitoba

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 16, 2019
• Informed Consent Form - Oct 20, 2015

More Information

Publications

None provided.

• Responsible Party: Dr. Rakesh C. Arora, Medical Director, Intensive Care Cardiac Sciences, St. Boniface Hospital
• ClinicalTrials.gov Identifier: NCT02219815
• Other Study ID Numbers: PREHAB
• First Posted: Aug 19, 2014
• Last Update Posted: Oct 28, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. Rakesh C. Arora, Medical Director, Intensive Care Cardiac Sciences, St. Boniface Hospital: Preoperative Care; Exercise Therapy; Cardiac Surgery; Frailty
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Period Title: Overall Study
STARTED	44	45
Post Hospital Discharge Analysis	42	39
3 Month Post Surgery	34	31
COMPLETED	22	21
NOT COMPLETED	22	24

Baseline Characteristics

Arm/Group Title	Standard Care	Prehab Intervention	Total
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.	Total of all reporting groups
Overall Participants	42	39	81
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 26.2%	4 10.3%	15 18.5%
>=65 years	31 73.8%	35 89.7%	66 81.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.3 (5.2)	71.4 (6.4)	70.3 (5.9)
Sex: Female, Male (Count of Participants)
Female	11 26.2%	5 12.8%	16 19.8%
Male	31 73.8%	34 87.2%	65 80.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Canada	42 100%	39 100%	81 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.
Description	Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days
Time Frame	Post-surgery (approximately 9 weeks after baseline)

Outcome Measure Data

Analysis Population Description

patients who successfully had scheduled surgery

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Count of Participants [Participants]	20 47.6%	16 41%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.551
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Baseline Exercise Capacity
Description	This measure will be assessed using the results of a 6 minute walk test.
Time Frame	baseline assessment - Study entry

Outcome Measure Data

Analysis Population Description

analysis of all participants who completed assessment at baseline and who had completed scheduled surgery

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Median (Inter-Quartile Range) [meters]	360	360

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.772
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Preoperative Exercise Capacity
Description	This measure will be assessed using the results of a 6 minute walk test.
Time Frame	Pre-Surgery (approximately 8 weeks after baseline)

Outcome Measure Data

Analysis Population Description

analysis of all participants who completed assessment at baseline and who had completed scheduled surgery

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	36	35
Median (Inter-Quartile Range) [meters]	360	363

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.231
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	3-Month Exercise Capacity
Description	This measure will be assessed using the results of a 6 minute walk test.
Time Frame	3 Months Post-Surgery (approximately 5 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	34	31
Median (Inter-Quartile Range) [meters]	400	405

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.659
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	1-Year Exercise Capacity
Description	This measure will be assessed using the results of a 6 minute walk test.
Time Frame	1 Year Post-Surgery (approximately 14 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	22	21
Median (Inter-Quartile Range) [Meters]	396	425

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.695
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Baseline Physical Activity Behaviour
Description	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time Frame	baseline assessment - Study entry

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Median (Inter-Quartile Range) [minutes]	55	58

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.820
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Preoperative Physical Activity Behaviour
Description	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time Frame	Pre-Surgery (approximately 8 weeks after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	36	35
Median (Inter-Quartile Range) [minutes]	60	61

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.991
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	3-Month Physical Activity Behaviour
Description	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time Frame	3 Months Post-Surgery (approximately 5 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	34	31
Median (Inter-Quartile Range) [Minutes]	71	86

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.594
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	1-Year Physical Activity Behaviour
Description	This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time Frame	1 Year Post-Surgery (approximately 14 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	22	21
Median (Inter-Quartile Range) [minutes]	46	101

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

10. Secondary Outcome

Title	Baseline Health-Related Quality of Life
Description	This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
Time Frame	baseline assessment - Study entry

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Median (Inter-Quartile Range) [score on a scale]	70	60

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.351
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

Title	Preoperatve Health-Related Quality of Life
Description	This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
Time Frame	Pre-Surgery (approximately 8 weeks after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	36	35
Median (Inter-Quartile Range) [score on a scale]	60	60

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.322
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	3-Month Health-Related Quality of Life
Description	This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
Time Frame	3 Months Post-Surgery (approximately 5 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	34	31
Median (Inter-Quartile Range) [score on a scale]	80	80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.988
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

13. Secondary Outcome

Title	1-Year Health-Related Quality of Life
Description	This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
Time Frame	1 Year Post-Surgery (approximately 14 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	22	21
Median (Inter-Quartile Range) [score on a scale]	80	85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.208
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

14. Secondary Outcome

Title	Baseline Frailty
Description	This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time Frame	baseline assessment - Study entry

Outcome Measure Data

Analysis Population Description

analysis of participants who completed the modified fried assessment at baseline assessment

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Median (Inter-Quartile Range) [score on a scale]	2	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.659
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

15. Secondary Outcome

Title	Preoperative Frailty
Description	This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time Frame	Pre-Surgery (approximately 8 weeks after baseline)

Outcome Measure Data

Analysis Population Description

analysis of participants who completed the modified fried assessment at preoperative assessment

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	36	35
Median (Inter-Quartile Range) [score on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.841
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

16. Secondary Outcome

Title	3-Month Frailty
Description	This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time Frame	3 Months Post-Surgery (approximately 5 months after baseline)

Outcome Measure Data

Analysis Population Description

analysis on all participants completing the 3-month time point post surgery

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	34	31
Median (Inter-Quartile Range) [score on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.646
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

17. Secondary Outcome

Title	1-Year Frailty
Description	This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time Frame	1 Year Post-Surgery (approximately 14 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	22	21
Median (Inter-Quartile Range) [Score on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.730
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

18. Secondary Outcome

Title	Baseline Anxiety
Description	This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
Time Frame	Baseline Assessment - Study entry

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Median (Inter-Quartile Range) [score on a scale]	4	2

19. Secondary Outcome

Title	Preoperative Anxiety
Description	This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
Time Frame	Pre-Surgery Assessment (approximately 8 weeks after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	36	35
Median (Inter-Quartile Range) [score on a scale]	2	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.681
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

20. Secondary Outcome

Title	3-Month Anxiety
Description	This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
Time Frame	3 Months Post-Surgery (approximately 5 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	34	31
Median (Inter-Quartile Range) [score on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.876
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

21. Secondary Outcome

Title	1-Year Anxiety
Description	This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed
Time Frame	1 Year Post-Surgery (approximately 14 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	22	21
Median (Inter-Quartile Range) [score on a scale]	1	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.141
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

22. Secondary Outcome

Title	Baseline Depression
Description	This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
Time Frame	Baseline Assessment - Study entry

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Median (Inter-Quartile Range) [score on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.655
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

23. Secondary Outcome

Title	Preoperative Depression
Description	This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
Time Frame	Pre-surgery Assessment ( 8 weeks after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	36	35
Median (Inter-Quartile Range) [score on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.691
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

24. Secondary Outcome

Title	3-Month Depression
Description	This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
Time Frame	3 Months Post-Surgery (approximately 5 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	34	31
Median (Inter-Quartile Range) [score on a scale]	1	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.709
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

25. Secondary Outcome

Title	1 Year Depression
Description	This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression
Time Frame	1 year Post-Surgery (approximately 14 months after baseline)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	22	21
Median (Inter-Quartile Range) [score on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Prehab Intervention
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.939
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

26. Secondary Outcome

Title	Postoperative Major Adverse Events
Description	Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.
Time Frame	Post-Surgery (approximately 9 weeks after baseline)

Outcome Measure Data

Analysis Population Description

we looked at adverse events (i.e. stroke) for participants who had their scheduled cardiac surgery

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	42	39
Count of Participants [Participants]	2 4.8%	1 2.6%

27. Secondary Outcome

Title	Postoperative Cardiac Rehabilitation Attendance
Description	Will be assessed using administrative data from participating cardiac rehabilitation facilities.
Time Frame	Post-Surgery (approximately 20 weeks after baseline)

Outcome Measure Data

Analysis Population Description

Counted the number of PREHAB participants who attended cardiac rehabilitation post cardiac surgery. this data was collected from only 51 participants

Arm/Group Title	Standard Care	Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Measure Participants	26	25
Count of Participants [Participants]	13 31%	18 46.2%

Adverse Events

Time Frame	March 2015 to September 2019 - 4 years, 6 months
Arm/Group Title	Standard Care		Prehab Intervention
Arm/Group Description	Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).		Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
All Cause Mortality
	Standard Care		Prehab Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/39 (0%)
Serious Adverse Events
	Standard Care		Prehab Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/42 (4.8%)		1/39 (2.6%)
Vascular disorders
Stroke	2/42 (4.8%)	2	1/39 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Standard Care		Prehab Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/42 (19%)		3/39 (7.7%)
Nervous system disorders
post operative Delirium	8/42 (19%)	8	3/39 (7.7%)	3

Limitations/Caveats

Recruitment was only 89 participants from an expected sample size of 244 participants. This was a major limitation regarding data analysis. Short cardiac surgery waitlists (i.e. surgery in less than 4 weeks) were impactful to study recruitment and intervention delivery

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.