Effects of a Hybrid Model of Cardiac Rehabilitation on Patient Outcomes

September 6, 2023 updated by: Kevin Minchin, Good Shepherd Integrated Healthcare Systems

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Good Shepherd Integrated Healthcare Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Minute Walk Test
Time Frame: Six Minutes
Treadmill Six Minute Walk Test
Six Minutes
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.
One Minute
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.
One Minute
Timed Agility Square Test
Time Frame: One Minute
Using agility ladder square to go in and out of designated two boxes
One Minute
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.
One minute
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).
One minute
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).
One minute
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?
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Good Shepherd Integrated Healthcare Systems

Investigators

  • Principal Investigator: Kevin Minchin, DPT, Good Shepherd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GoodShepherdIHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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