Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

Overview

About this study

The purpose of this study is to evaluate the effect of adding an individualized, home-based, mobile-health delivered physical function training program to traditional outpatient cardiac rehabilitation on measures of physical function, fall risk, self-reported balance confidence, and health-related quality of life.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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:

  • Non-English speaker and unable to interact with exercise prescription mobile application.
  • Advanced dementia.
  • Wheelchair bound.
  • Vision loss.
  • Any other physical impairment that precludes completing physical assessment and/or exercise interventions as judges by the study staff.
  • 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).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/2/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bryan Taylor, Ph.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Scales, Ph.D., M.S.

Closed for enrollment

Contact information:

Jennifer Hill

(480) 301-4720

Hill.Jennifer4@mayo.edu

More information

Publications

Publications are currently not available