Clinical trial NCT06030115: Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Coronary Artery Bypass Graft CABG
Stent
Valve Replacement
Keywords: Physical Therapy
Cardiopulmonary Rehabilitation
Cardiac Surgery
Exercise
Heart Rate
Objective Outcome Assessments
Lead sponsor: Good Shepherd Integrated Healthcare Systems
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Exclusion Criteria:

* Implantable cardioverter defibrillator (ICD)
* Pacemaker (PPM)
* Heart Transplant
* Left ventricular assist device (LVAD)
* All other cardiac procedures not listed within inclusion criteria
* Diagnosed a-fib
* Participants who attended cardiac rehabilitation before

Primary outcomes:
measure: Six Minute Walk Test
timeFrame: Six Minutes
measure: Timed Sit To Stand Test
timeFrame: One Minute
measure: Timed Step Test
timeFrame: One Minute
measure: Timed Agility Square Test
timeFrame: One Minute
measure: Achieved Target Heart Rate (AHRI%)
timeFrame: One minute
measure: Heart Rate Recovery (HRR%)
timeFrame: One minute
measure: Intensity Recovery Total Score (IR%)
timeFrame: One minute
measure: Subjective Questionnaire
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Good Shepherd Integrated Healthcare Systems
state: Nevada
Study officials:
affiliation: Good Shepherd
name: Kevin Minchin, DPT
role: PRINCIPAL_INVESTIGATOR
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