Recruiting

Cardiac Rehabilitation

Sponsor:

Mayo Clinic

Code:

NCT05826587

Conditions

Cardiac Rehabilitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home-based, m-Health Delivered Physical Function Training

Cardiac Rehabilitation & Exercise Prescription

Connected mHealth mobile application

Study Details

Brief summary:

The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can done at home helps to improve the ability to perform standard physical tasks, confidence in balance, and health-related quality-of-life

Conditions

Cardiac Rehabilitation

Study ID

NCT05826587

Start date

Oct 9, 2023

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jan 5, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients referred to and who undergo early outpatient CR irrespective of diagnosis will be eligible for the study.
  • All participants must have access to a smart mobile device.

Exclusion Criteria:

  • Advanced dementia.
  • Wheelchair bound.
  • Vision loss.
  • Patients that underwent sternotomy within 12-weeks will be excluded from the upper body muscular strength/power assessment and associated upper body training. At the time of enrollment into CR, balance, upper body muscular fitness, and lower body muscular fitness will be assessed in each subject before they are randomized at a 1:1 allocation ratio into one of two parallel groups:
  • Standard early outpatient center-based supervised CR only (control; CR); or
  • Early outpatient center-based supervised CR plus individualized, home-based, m-Health delivered physical function training (experimental group; CR+PFt). Balance, upper body muscular fitness, and lower body muscular fitness and gait will be reassessed in each participant after 5-to-6 weeks of CR and again upon completion of the CR program. Patient reported measures of fall risk will be measured at baseline with the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit. Balance confidence, health-related quality of life, physical activity level, and functional capacity will be evaluated before and after CR and CR+PFt using the Activities-Specific Balance Confidence (ABC) Scale, the Dartmouth Primary Care Cooperative Information Project (COOP) charts, and the Duke Activity Status Index (DASI).

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Control group of cardiac rehabilitation only

experimental: Intervention group of additional balance and muscle strength training

Interventions

Home-based, m-Health Delivered Physical Function Training

An individualized home exercise physical function training will be prescribed. This would include 5 balance training exercises and 1-2 upper and lower-body muscular conditioning exercises (i.e., wall push-up and chair stand) prescribed 3 days/week over the course of a 6-week period. Subjects will be assigned exercises from 1 of 3 different levels of exercise progression based on performance during the baseline muscular fitness assessment (functional chair stand and static chest throw).

Cardiac Rehabilitation & Exercise Prescription

Standard, clinically indicated cardiac rehabilitation and exercise program. Approximately 30 to 40 minutes of aerobic exercise within a prescribed rating of perceived exertion (RPE 11-14) and/or target heart rate and approximately 15 to 20 minutes of both upper and lower body resistance exercise up to three times per week for up to at least 12 weeks. In addition, subjects are provided with home exercise instructions, and will be expected to exercise for 30 to 60 minutes at home.

Connected mHealth mobile application

Mobile application that allows subjects to track their independent home exercise with the option of heart rate monitoring by connecting to an external heart rate monitoring device.

Primary outcome measure

  • Change in self-reported physical function [ Time Frame: Baseline, approximately 7 to 14 weeks ]
  • Change in fall risk [ Time Frame: Baseline, approximately 7 to 14 weeks ]
  • Change in self-reported balance confidence [ Time Frame: Baseline, approximately 7 to 14 weeks ]
  • Change in health-related quality of life [ Time Frame: Baseline, approximately 7 to 14 weeks ]

Central Contacts and Locations

Central contacts

Robert Scales, PhD, MS

480-791-8935scales.robert@may.edu

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Robert Scales

4807918935scales.robert@mayo.edu

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Kevin Kurtz

9049538436kurtz.kevin@mayo.edu

Principal Investigator:

Bryan Taylor, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-20.