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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age

Newly implanted with a HeartMate 3™ LVAD for the first time

Able to ambulate independently (with or without the use of an assistive device)

Owns a smartphone with Internet connection

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Intervention

    Behavioral

    See arm description.

  • Usual Care

    Behavioral

    See arm description.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Exercise InterventionExperimental treatment 1 intervention
Group B: Usual CareOther 1 intervention

Trial outcomes

Primary outcomes

1

Effects of exercise intervention on physical activity and capacity (step count)

The investigators will compare the effects of the exercise intervention vs. usual care on physical activity and capacity measured by daily steps captured by an activity tracking watch.

Time frame
6 months
2

Effects of exercise intervention on physical activity and capacity (distance)

The investigators will compare the effects of the exercise intervention vs. usual care on physical activity and capacity measured by six-minute walk test distance.

Time frame
6 months

Secondary outcomes

1

Effects of exercise intervention on frailty and muscle mass (frailty status)

The investigators will compare the effects of the exercise intervention vs. usual care on frailty and muscle mass by evaluating frailty status (number of abnormal Fried frailty criteria, including handgrip strength).

Time frame
6 months
2

Effects of exercise intervention on frailty and muscle mass (muscle quantity)

The investigators will compare the effects of the exercise intervention vs. usual care on frailty and muscle mass by evaluating muscle quantity (pectoralis muscle assessed by chest computed tomography scan).

Time frame
6 months
3

Effects of exercise intervention on quality of life

The investigators will compare the effects of the exercise intervention vs. usual care on quality of life measured by the Kansas City Cardiomyopathy Questionnaire-12.

Time frame
6 months
4

Cost-effectiveness of the exercise intervention vs. usual care

The investigators will determine the cost-effectiveness of the exercise intervention vs. usual care

Time frame
6 months

Other outcomes

Sponsors and contacts

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

University of Pennsylvania

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator