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Completed

NCT Number: NCT06030115

Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes

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.

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Key information

Conditions

Cardiac Surgery Behavior Coronary Artery Bypass Graft CABG Motor Activity STENT Valve Replacement

Sex eligibility

All sexes

Study type

Observational

Primary location

Good Shepherd Integrated Healthcare Systems

Las Vegas, Nevada, 89119, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Six Minute Walk Test

    Time frame: Six Minutes

    Treadmill Six Minute Walk Test

  2. Timed Sit To Stand Test

    Time frame: 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.

  3. Timed Step Test

    Time frame: 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.

  4. Timed Agility Square Test

    Time frame: One Minute

    Using agility ladder square to go in and out of designated two boxes

  5. Achieved Target Heart Rate (AHRI%)

    Time frame: 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.

  6. Heart Rate Recovery (HRR%)

    Time frame: 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).

  7. Intensity Recovery Total Score (IR%)

    Time frame: 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).

  8. Subjective Questionnaire

    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.

    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?

Sponsors and collaborators

Lead sponsor

Good Shepherd Integrated Healthcare Systems

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2023
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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