Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation

Part of paid clinical trials in Detroit, Michigan.

Sponsor
University of Pennsylvania
Study ID
NCT06291922
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise Intervention — BEHAVIORAL
    See arm description.
  • Usual Care — BEHAVIORAL
    See arm description.

Study Details

The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life.

Key Dates

Start date
Aug 14, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exercise Intervention
    The exercise intervention focuses on walking and strengthening exercises with a standardized protocol to guide exercise prescription and exercise progression based on data obtained from the activity tracking watch and smartphone app.
  • Other: Usual Care
    The usual care group will be encouraged to increase daily walking activity as they tolerate, while complying with any activity restrictions from their clinical team. The Physical Activity Guidelines for Americans recommend increasing daily walking activity as tolerated to an average of 30 minutes daily, 5 times a week.

Primary Outcome Measure

Effects of exercise intervention on physical activity and capacity (step count) [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Clinical Research Coordinator
Cleveland Clinic FoundationClevelandOhio44195
Clinical Research Coordinator
University of PennsylvaniaPhiladelphiaPennsylvania19104
Clinical Research Coordinator
University of Utah HealthSalt Lake CityUtah84112
Clinical Research Coordinator

Find similar trials in Detroit, MI

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Henry Ford Health· Detroit, MICleveland Clinic Foundation· Cleveland, OHUniversity of Pennsylvania· Philadelphia, PAUniversity of Utah Health· Salt Lake City, UT

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