Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05826587

Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiac Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Arizona, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Home-based, m-Health Delivered Physical Function Training

Behavioral

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

Behavioral

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

Other

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 outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Scales, PhD, MS

CONTACT

[email protected]

480-791-8935

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Jan 20, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.