Heart FailureMOVE-LVAD IINCT06291922
Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation
A study testing Exercise Intervention in people with Heart Failure, run by University of Pennsylvania at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Aug 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 1. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Clinical Research Coordinator
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Clinical Research Coordinator
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Clinical Research Coordinator
- Recruiting
University of Utah Health
Salt Lake City, Utah, 84112
Clinical Research Coordinator
About this study
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.
Read the detailed description
Eligible subjects who sign the consent form will be randomized to either the exercise intervention arm or the usual care arm. As part of the baseline assessment, all subjects will measure their average daily steps during week 1 using a Garmin activity tracking watch, complete a six-minute walk test, complete frailty testing (including measurements of handgrip strength and gait speed), and complete surveys. Subjects will also complete a CT scan to evaluate muscle mass. After completing baseline assessments, subjects will be randomized to one of the study arms.
Subjects in the usual care arm will receive a Garmin activity tracking watch to wear continuously. Subjects will receive reminders from a smartphone app (Datos) to wear the watch. Subjects will be encouraged to increase daily walking as tolerated. In addition to standard of care clinic visits, they will receive phone calls from the study research coordinator reminding them to wear the watch and to walk.
Subjects in the exercise intervention arm will first have an initial training session with an interventionist to review exercises and safe practices. Subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strengthening exercises (including use of resistance bands and light weights). Subjects' progress in the exercise program will be remotely monitored using the activity tracking watch and the smartphone app, and subjects will complete questionnaires through the app. Subjects will complete video calls with the interventionist throughout the duration of the study and will receive updated personalized exercise prescriptions based on their progress.
Subjects in both study arms will have regular follow up VAD Clinic appointments per standard of care practices. Subjects will complete questionnaires, complete six-minute walk testing, complete frailty testing (including measurements of handgrip strength and gait speed), and undergo a chest CT scan without contrast as part of follow up activities. Throughout the study, data will be collected from the medical record.
- Conditions
- Heart Failure
- Being tested
- Exercise Intervention, Usual Care
- Keywords
- Left ventricular assist device, Exercise, Ventricular assist device, HeartMate 3 (HM3)
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
See arm description.
Usual CareBehavioural
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (4)
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).
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
Cost-effectiveness of the exercise intervention vs. usual care
The investigators will determine the cost-effectiveness of the exercise intervention vs. usual care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start14 Aug 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Himabindu Vidula, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291922
- Sponsor's protocol ID
- 853181
- Other IDs
- R01HL166621
- Acronym
- MOVE-LVAD II
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT06291922
- Acronym / sponsor ID
- MOVE-LVAD II / 853181
- Conditions
- Heart Failure
- Keywords
- Left ventricular assist device, Exercise, Ventricular assist device, HeartMate 3 (HM3)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible subjects who sign the consent form will be randomized to either the exercise intervention arm or the usual care arm. As part of the baseline assessment, all subjects will measure their average daily steps during week 1 using a Garmin activity tracking watch, complete a six-minute walk test, complete frailty testing (including measurements of handgrip strength and gait speed), and complete surveys. Subjects will also complete a CT scan to evaluate muscle mass. After completing baseline assessments, subjects will be randomized to one of the study arms.
Subjects in the usual care arm will receive a Garmin activity tracking watch to wear continuously. Subjects will receive reminders from a smartphone app (Datos) to wear the watch. Subjects will be encouraged to increase daily walking as tolerated. In addition to standard of care clinic visits, they will receive phone calls from the study research coordinator reminding them to wear the watch and to walk.
Subjects in the exercise intervention arm will first have an initial training session with an interventionist to review exercises and safe practices. Subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strengthening exercises (including use of resistance bands and light weights). Subjects' progress in the exercise program will be remotely monitored using the activity tracking watch and the smartphone app, and subjects will complete questionnaires through the app. Subjects will complete video calls with the interventionist throughout the duration of the study and will receive updated personalized exercise prescriptions based on their progress.
Subjects in both study arms will have regular follow up VAD Clinic appointments per standard of care practices. Subjects will complete questionnaires, complete six-minute walk testing, complete frailty testing (including measurements of handgrip strength and gait speed), and undergo a chest CT scan without contrast as part of follow up activities. Throughout the study, data will be collected from the medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionThe 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. |
| Usual Care | Other | Behavioral: Usual CareThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- 1. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionSee arm description. | Behavioural | Exercise Intervention |
| Usual CareSee arm description. | Behavioural | Usual Care |
Primary outcome
Effects of exercise intervention on physical activity and capacity (step count)
Time frame: 6 months
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.
Effects of exercise intervention on physical activity and capacity (distance)
Time frame: 6 months
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.
4 secondary outcomes
Effects of exercise intervention on frailty and muscle mass (frailty status)
Time frame: 6 months
Effects of exercise intervention on frailty and muscle mass (muscle quantity)
Time frame: 6 months
Effects of exercise intervention on quality of life
Time frame: 6 months
Cost-effectiveness of the exercise intervention vs. usual care
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Himabindu Vidula, MD principal investigator
University of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Heart Failure, run by University of Pennsylvania at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (215-615-4480, sadie.butcher@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of exercise intervention on physical activity and capacity (step count) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.