Health TrialsbyHealthPanel

Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

ConditionCardiac Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Advanced dementia.

Wheelchair bound.

Vision loss.

Standard early outpatient center-based supervised CR only (control; CR); or

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Control group of cardiac rehabilitation onlyActive comparator 2 interventions
Group B: Intervention group of additional balance and muscle strength trainingExperimental treatment 3 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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