Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes

Sponsor

Good Shepherd Integrated Healthcare Systems (Other)

Overall Status

Completed

CT.gov ID

NCT06030115

Collaborator

(none)

100

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine if the standard of care at a cardiac rehabilitation center using what the investigators term to be "hybrid model" on the exercise component of cardiac rehabilitation is associated with improved adherence and outcomes. Discuss the hybrid model in comparison to traditional cardiac rehabilitation and layout a template on how to incorporate this hybrid model. Discuss factors that may lead to poor adherence and attendance to cardiac rehabilitation.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Coronary Artery Bypass Graft CABG Stent Valve Replacement	Other: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)

Detailed Description

Purpose: The aim of this prospective cohort study was to determine the effectiveness of an individualized physical therapist (PT) driven hybrid model of the exercise component of cardiac rehabilitation (CR) that uses a novel intensity-recovery progression protocol (IRPP) and cardiac testing template (CTT) to assess achieved heart rate intensity (AHRI%), heart rate recovery (HRR%), and intensity-recovery total (IR%) as indicators to guide treatment.

Methods: Assessment of a subjective questionnaire, vital signs, treadmill 6-minute walk (6MW), 1-minute sit-to-stand (1STS), 1-minute step (1ST), and 1-minute agility square tests (1AST) were assessed on 100 participants during the 36-visit program. The hybrid model was led by a PT, was longer in duration, added high intensity interval training (HIIT) to continuous aerobic exercise training (CAET) and resistance training, and used a 1:1 treatment ratio. Treatment intensity and progression were measured based on clinical decision making through the IRPP and CTT.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effects of a Physical Therapist-driven Individualized Hybrid Model of the Exercise Component of Cardiac Rehabilitation on Patient Outcomes: a Prospective Cohort Study

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cardiac Rehab Patients All participants referred to the clinic meeting the inclusion and exclusion criteria who wanted to participate in the study.	Other: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP) Data collected on participants who completed the intensity recovery progression protocol program

Arm

Intervention/Treatment

Cardiac Rehab Patients

All participants referred to the clinic meeting the inclusion and exclusion criteria who wanted to participate in the study.

Other: Exercise Component Of Cardiac Rehabilitation (Hybrid Model) Intensity Recovery Progression Protocol (IRPP)

Data collected on participants who completed the intensity recovery progression protocol program

Outcome Measures

Primary Outcome Measures

Six Minute Walk Test [Six Minutes]
Treadmill Six Minute Walk Test
Timed Sit To Stand Test [One Minute]
A standardized test measuring how many times an individual can stand from a standardized seated position in one minute using hand support to push off.
Timed Step Test [One Minute]
A test measuring how many repetitions an individual can go up and down a standardized step while using bilateral arm support on a rail.
Timed Agility Square Test [One Minute]
Using agility ladder square to go in and out of designated two boxes
Achieved Target Heart Rate (AHRI%) [One minute]
Heart rate achieved during outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first). Participants expected to attend the program at a frequency of 2x a week for 36 total visits.
Heart Rate Recovery (HRR%) [One minute]
Heart rate observed one minute after outcome measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).
Intensity Recovery Total Score (IR%) [One minute]
The total of the AHRI + HRR during objective measurements (six minute walk test, timed sit to stand test, timed step test, timed agility square test). Completed every 5 visits from date of initiation up to 1 year after initiation or until visit 36 achieved (whichever comes first).
Subjective Questionnaire [From date of initiation of study up to 1 year after initiation. Collected on Visit 1, Visit 15, Visit 30 for each participant, who were expected to attend the program at a frequency of 2x a week for 36 total sessions.]
Three questions (where higher scores denote better outcomes) Question 1: Rate your endurance (using a visual analog scale from 0-100% marked every 10%)? Question 2: Estimate how many stairs you could go up using arm support before you would have to take a break? Question 3: Estimate how many hours of exercise you completed in the previous 7 days?

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Underwent cardiac surgery (CABG, PCI with stent placement, and valve replacement)
Surgery was within the previous 365 days
Could independently ambulate into the facility.