An observational study in Cardiac Surgery, Coronary Artery Bypass Graft CABG and Stent, sponsored by Good Shepherd Integrated Healthcare Systems. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Good Shepherd Integrated Healthcare Systems · Observational
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.
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.
This is the only study on the registry with Good Shepherd Integrated Healthcare Systems as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The participants analyzed (73 males, 27 females) had an average starting age of 66.1 years (SD=9.6; range 41-88 years). The admitting diagnoses were 50% stent, 37% CABG, 8% valve replacement and 5% a combination of the above.
Exclusion Criteria:
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
Six Minute Walk Test
Treadmill Six Minute Walk Test
Time frame: Six Minutes
Timed Sit To Stand Test
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.
Time frame: One Minute
Timed Step Test
A test measuring how many repetitions an individual can go up and down a standardized step while using bilateral arm support on a rail.
Time frame: One Minute
Timed Agility Square Test
Using agility ladder square to go in and out of designated two boxes
Time frame: One Minute
Achieved Target Heart Rate (AHRI%)
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.
Time frame: One minute
Heart Rate Recovery (HRR%)
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).
Time frame: One minute
Intensity Recovery Total Score (IR%)
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).
Time frame: One minute
Subjective Questionnaire
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?
Time frame: 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.
Plan to share: No — IPD (decodified) will be stored in a password protected laptop in a locked room in a locked file cabinet at the clinic site. The statistical summarized analysis will be the main focus for the public and other researchers. The cardiac testing template in excel format will be available for other researchers looking to use the hybrid model explained in the study, however, this template will not contain individualized personal data.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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