Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

• Sponsor: Toronto Rehabilitation Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00929994
• Collaborator: Heart and Stroke Foundation of Canada (Other)
• Enrollment: 20
• Location: 1
• Duration (Months): 56
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

It is hypothesized that the addition of formal cardiac rehabilitation to standard care will result in long-term improvements in cardiovascular fitness and functional capacity in individuals who have suffered a transient ischemic attack (TIA) or minor stroke.

Furthermore, it is proposed that the addition of cardiac rehabilitation will influence depressive symptoms and cognition.

Condition or Disease	Intervention/Treatment	Phase
Transient Ischemic Attack	Behavioral: Cardiac Rehabilitation

Detailed Description

A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA, preventative measures can be taken to target modifiable risk factors, one of which is physical inactivity. The current proposal focuses on the use of an established model of care (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to maximize physical activity and minimize risk of future cardiovascular events. This will be a one-group pre/post design study with a 3 month non-intervention period. Participants will undergo measures at baseline and 3 months (non intervention period) then after 6 months of cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive symptoms).

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Exercise Following a 3 month non intervention period, participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.	Behavioral: Cardiac Rehabilitation; Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.

Outcome Measures

Primary Outcome Measures

1. Functional Walk Test [Baseline, 3 months, 6 months (Six Minute Walk Distance)]

   6 minute walk test: the longest distance a person can walk for a duration of 6 minutes

2. Cardiovascular Fitness (VO2peak) [Baseline (after the 3 month non-intervention period) and after 6 months of participation.]

   To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.

Secondary Outcome Measures

1. Center for Epidemiologic Studies Depression Scale (CES-D). [Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation]

   Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).

2. Cognition [Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation]

   Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with TIA

• Three months post-TIA

• Ability to understand the process and instructions for exercise training and provide informed consent

Exclusion Criteria:

• Resting Blood Pressure greater than 160/100 despite medication

• Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)

• Current and extensive exercise participation

• Hypertrophic Cardiomyopathy

• Unstable Angina

• Orthostatic BP decrease of > 20 mm Hg with symptoms

• Other musculoskeletal impairments which would limit the participants ability to walk sufficient durations

• Pain or other co-morbidities (e.g., unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation

• Cognitive or behavioural issues that would limit participation in exercise testing and training

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Rehabilitation Institute - Rumsey Center	Toronto	Ontario	Canada	M4G 1R7

Sponsors and Collaborators

• Toronto Rehabilitation Institute
• Heart and Stroke Foundation of Canada

Investigators

• Principal Investigator: Dina Brooks, PhD, Toronto Rehabilitation Institute
• Principal Investigator: William E McIllroy, PhD, University of Waterloo
• Principal Investigator: Paul Oh, MD, Toronto Rehabilitation Institute
• Principal Investigator: Sandra Black, MD, Sunnybrook and Women's College Health Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dina Brooks, Professor, Toronto Rehabilitation Institute
• ClinicalTrials.gov Identifier: NCT00929994
• Other Study ID Numbers: Brooks - 001
• First Posted: Jun 30, 2009
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Dina Brooks, Professor, Toronto Rehabilitation Institute: cardiac rehab
• Additional relevant MeSH terms: Ischemic Attack, Transient; Ischemia

Study Results

Participant Flow

Arm/Group Title	Exercise
Arm/Group Description	Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding the exercise program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Period Title: Overall Study
STARTED	20
COMPLETED	14
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Exercise
Arm/Group Description	Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (11.2)
Sex: Female, Male (Count of Participants)
Female	13 65%
Male	7 35%
Region of Enrollment (participants) [Number]
Canada	20 100%

Outcome Measures

1. Primary Outcome

Title	Functional Walk Test
Description	6 minute walk test: the longest distance a person can walk for a duration of 6 minutes
Time Frame	Baseline, 3 months, 6 months (Six Minute Walk Distance)

Outcome Measure Data

Analysis Population Description

Transient Ischemic Attack participants who completed the 6 month intervention.

Arm/Group Title	Exercise
Arm/Group Description	Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. A 3 month non-intervention period will precede the 6 month cardiac rehabilitation training program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Measure Participants	14
Baseline	498.4 (95.2)
3 months	503.2 (111.1)
6 months	564.2 (139.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise
	Comments	With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.06
	Comments	A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all >.05).
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Exercise
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Cardiovascular Fitness (VO2peak)
Description	To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.
Time Frame	Baseline (after the 3 month non-intervention period) and after 6 months of participation.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise
Arm/Group Description	Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Measure Participants	14
Baseline	16.7 (5)
6 months	19.1 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Center for Epidemiologic Studies Depression Scale (CES-D).
Description	Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).
Time Frame	Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Outcome Measure Data

Analysis Population Description

Transient Ischemic Attack. Two patients did not complete questionnaires.

Arm/Group Title	Exercise
Arm/Group Description	Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program after a 12 week period of non intervention which will last 6 months and combine both resistance and aerobic training. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Measure Participants	12
Baseline	6.5 (6)
3 months	7.6 (5)
6 months	4.3 (5.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise
	Comments	With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments	A Bonferroni correction for multiple testing was used for post-hoc contrasts.
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Cognition
Description	Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.
Time Frame	Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Outcome Measure Data

Analysis Population Description

TIA. Three subjects did not complete the assessment at each time point.

Arm/Group Title	Exercise
Arm/Group Description	Following a 3 month non intervention period, participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Measure Participants	11
Baseline	26.5 (2.4)
3 months	26.8 (3.4)
6 months	27.1 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exercise
	Comments	With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	A Bonferroni correction for multiple testing was used for post-hoc contrasts
	Method	ANOVA
	Comments

Adverse Events

Arm/Group Title	Exercise
Arm/Group Description	Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding cardiac rehabilitation. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
All Cause Mortality
	Exercise
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Exercise
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Exercise
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

This study was conducted in a single centre located in a large city centre and may lack generalizability to other programs, including those where CR services are not publicly funded.

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.