NCT06291922

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
25mo left

Started Aug 2024

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Aug 2024Jun 2028

First Submitted

Initial submission to the registry

February 19, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

August 14, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

February 19, 2024

Last Update Submit

September 22, 2025

Conditions

Heart Failure

Keywords

Left ventricular assist deviceExerciseVentricular assist deviceHeartMate 3 (HM3)

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 months

  • 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.

    6 months

Secondary Outcomes (4)

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

    6 months

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

    6 months

  • Effects of exercise intervention on quality of life

    6 months

  • Cost-effectiveness of the exercise intervention vs. usual care

    6 months

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Exercise Intervention

Usual Care

OTHER

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.

Behavioral: Usual Care

Interventions

Exercise InterventionBEHAVIORAL

See arm description.

Exercise Intervention
Usual CareBEHAVIORAL

See arm description.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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
  • Patient will be discharged home with LVAD or patient will be living at home with LVAD within 45 days of index discharge

You may not qualify if:

  • \. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Utah Health

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Himabindu Vidula, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

215-615-4480sadie.butcher@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

March 4, 2024

Study Start

August 14, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations

US(4)