CClinicalTrials.gg
RecruitingNCT05826587Updated Jan 20, 2026

Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

An interventional study of Home-based, m-Health Delivered Physical Function Training and Cardiac Rehabilitation & Exercise Prescription in Cardiac Rehabilitation, sponsored by Mayo Clinic. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Cardiac Rehabilitation
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Active comparator
    Control group of cardiac rehabilitation only

    Behavioral: Cardiac Rehabilitation & Exercise Prescription · Other: Connected mHealth mobile application

  • Experimental
    Intervention group of additional balance and muscle strength training

    Behavioral: Home-based, m-Health Delivered Physical Function Training · Behavioral: Cardiac Rehabilitation & Exercise Prescription · Other: Connected mHealth mobile application

Interventions

  • BehavioralHome-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).

  • BehavioralCardiac 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.

  • OtherConnected 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.

06

What researchers measure

Primary outcomes

  1. Change in self-reported physical function

    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).

    Time frame: Baseline, approximately 7 to 14 weeks

  2. Change in fall risk

    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.

    Time frame: Baseline, approximately 7 to 14 weeks

  3. Change in self-reported balance confidence

    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.

    Time frame: Baseline, approximately 7 to 14 weeks

  4. Change in health-related quality of life

    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.

    Time frame: Baseline, approximately 7 to 14 weeks

07

Study locations

2 of 2 sites recruiting
  • Mayo Clinic Arizona
    Scottsdale, Arizona 85259, United States
    Recruiting
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
    • Kevin Kurtz · Contact · kurtz.kevin@mayo.edu · 9049538436
    • Bryan Taylor, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05826587
Lead sponsor
Mayo Clinic
Responsible party
Robert Scales (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Apr 24, 2023
Start date
Oct 9, 2023
Primary completion
Jan 5, 2026
Completion
Dec 2026 (estimated)
Last update
Jan 20, 2026

Study contacts

Robert Scales, PhD, MS
Contact
scales.robert@may.edu
480-791-8935
Robert Scales, PhD, MS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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