Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

January 15, 2026 updated by: Robert Scales, Mayo Clinic

A Mobile-Health (mHealth) Fall Risk Prevention Intervention in Cardiac Rehabilitation: A Randomized Control Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Traditional cardiac rehabilitation programs typically prioritize aerobic exercise (e.g., walking, cycling, etc.) with much less emphasis on improving physical function and strength, which is very important in, for example, decreasing the risk of falling. Through this research, researchers will implement a comprehensive fall risk screening and physical function assessment supported with individualized therapeutic exercise(s). Researchers hope that this will decrease fall risk, enhance rehabilitation experience, and improve ability to perform tasks of daily living.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Florida
        • Principal Investigator:
          • Bryan Taylor, PhD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group of cardiac rehabilitation only
Behavioral: 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.
Other: 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.
Experimental: Intervention group of additional balance and muscle strength training
Behavioral: 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.
Other: 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.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported physical function
Time Frame: Baseline, approximately 7 to 14 weeks
Measured using the Duke Activity Status Index (DASI) a self-reported questionnaire to subjectively measure physical activity level and functional capacity. The questionnaire includes twelve questions with each question weighted differently to assign a total score. Functional capacity is graded based on the total score (i.e., Good = DASI >31.95 or Poor = DASI <31.95).
Baseline, approximately 7 to 14 weeks
Change in fall risk
Time Frame: Baseline, approximately 7 to 14 weeks
Measured using the Stop Elderly Accidents, Deaths, and Injuries (STEADI) assessment component which consists of 12 closed-ended questions. A score >4 is considered at risk for falling.
Baseline, approximately 7 to 14 weeks
Change in self-reported balance confidence
Time Frame: Baseline, approximately 7 to 14 weeks
Measured using the Activities-Specific Balance Confidence Scale, a 16-item questionnaire that is scored with a Likert scale (0-100%). The subject is graded on level of confidence associated with fall risk while performing a range of daily activities with varying levels of difficulty. Higher scores greater confidence.
Baseline, approximately 7 to 14 weeks
Change in health-related quality of life
Time Frame: Baseline, approximately 7 to 14 weeks
Measured using the Dartmouth Primary Care Cooperative Information Project (COOP), a nine-question quality of life survey. There are nine categories including: physical condition, emotional condition, daily work, social activities, change in condition, overall condition, social support, quality of life and pain. Subjects will be graded with a total and sub-category score. Total scores range from 9-45 and a lower total score indicates a higher quality of life.
Baseline, approximately 7 to 14 weeks

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Robert Scales, PhD, MS, Mayo Clinic

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.

Helpful Links

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)

October 9, 2023

Primary Completion (Actual)

January 5, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-001155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Cardiac Rehabilitation

Clinical Trials on Cardiac Rehabilitation & Exercise Prescription

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe