Heart FailureMOVE-LVADNCT04942353
Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients
A study testing Home-based Exercise Rehabilitation. in people with Heart Failure and Left Ventricular Dysfunction, run by University of Rochester at 1 site in United States.
Trial summary
To demonstrate that home-based exercise rehabilitation (HER) compared to usual care (UC) results in a significant reduction in healthcare utilization in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients.(defined as rehospitalization, VAD Clinic visits, and ER visits during the 1st year after index… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Ventricular Dysfunction
- What is being tested?
- Home-based Exercise Rehabilitation.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 17 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 on the date of randomization
- Patient implanted with a new HeartMate 3 LVAD at URMC
- Patients enrolling in the study at the time of index discharge home following new HM3 LVAD implantation will be evaluated by a HF cardiologist and physical therapist and will need to demonstrate ability to ambulate independently. Patients enrolling in the study after their index discharge home following HM3 LVAD implantation will be evaluated by a HF cardiologist or VAD Coordinator and will need to demonstrate ability to ambulate independently.
- Patient willing to participate in HER.
- Patient owns a smartphone with Internet connection.
Who cannot join
- Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated HF, uncontrolled arrhythmias, unstable angina).
- Patient with a life expectancy <12 months.
- Patient unwilling to sign the consent for participation.
- Patient unwilling or unable to cooperate with the study protocol
- Patient who does not anticipate being a resident of the area for the scheduled duration of the research study
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3TM Patients: A Randomized Controlled Pilot Study (MOVE-LVAD)
To demonstrate that home-based exercise rehabilitation (HER) compared to usual care (UC) results in a significant reduction in healthcare utilization in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients.(defined as rehospitalization, VAD Clinic visits, and ER visits during the 1st year after index discharge following LVAD implantation).
Read the detailed description
HER Subjects:
Get Garmin activity watch (has its own smartphone app to be activated)*, Datos app Get resistance bands and light weights Exercise prescription: Initially by physical therapist prior to discharge home \& updated every month.
UC Subjects:
Get Garmin activity watch (has its own smartphone app to be activated), Datos app Exercise prescription: Try to get to 30 min of exercise 5 days a week
- Conditions
- Heart Failure, Left Ventricular Dysfunction
- Being tested
- Home-based Exercise Rehabilitation., Usual Care
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Exercise Rehabilitation.Behavioural
Based on physical therapist or exercise physiologist assessment, subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strength training (including exercises using light-weight hand-weights and upper and lower body exercises using resistance bands). Research team will provide updated exercise prescription based on Garmin watch/Datos app activity data and Datos app data (including Borg scale).
Usual CareBehavioural
Patients receive a standardized recommendation to increase their walking activity to 30 minutes 5 days/week.
| Study group | Role | What they receive |
|---|---|---|
| Home-based Exercise Rehabilitation | Experimental | Not described Receives: Behavioral: Home-based Exercise Rehabilitation. |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of clinic visits
Healthcare utilization will be measured as the sum of all-cause rehospitalizations, outpatient VAD Clinic visits and emergency room visits room visits
Measured: 1 year
Secondary outcomes (4)
Mean number of days out of the hospital
Measured: 1 year
Mean change in the number of daily steps taken
Steps will be tracked using the Garmin watch. The Garmin watch uses Global Positioning System (GPS) tracking and an accelerometer to continuously monitor activity and provides data on average number of steps per day.
Measured: 1 year
Mean change 6-minute walk distance
Measured: baseline to 1 year
Mean change in number of participants with improved quality of life
Quality of life will be measured using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The scale ranges from 12-70 with higher scores indicating better quality of life.
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start19 Oct 2020
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
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 RochesterThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Himabindu Vidula, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942353
- Sponsor's protocol ID
- STUDY00004656
- Acronym
- MOVE-LVAD
- Status last verified
- Nov 2023
- First submitted
- 17 Jun 2021
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3TM Patients: A Randomized Controlled Pilot Study (MOVE-LVAD)
- ClinicalTrials.gov ID
- NCT04942353
- Acronym / sponsor ID
- MOVE-LVAD / STUDY00004656
- Conditions
- Heart Failure, Left Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 28 Jun 2021 (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.
To demonstrate that home-based exercise rehabilitation (HER) compared to usual care (UC) results in a significant reduction in healthcare utilization in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients.(defined as rehospitalization, VAD Clinic visits, and ER visits during the 1st year after index discharge following LVAD implantation).
Detailed description
HER Subjects:
Get Garmin activity watch (has its own smartphone app to be activated)*, Datos app Get resistance bands and light weights Exercise prescription: Initially by physical therapist prior to discharge home \& updated every month.
UC Subjects:
Get Garmin activity watch (has its own smartphone app to be activated), Datos app Exercise prescription: Try to get to 30 min of exercise 5 days a week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Exercise Rehabilitation | Experimental | Behavioral: Home-based Exercise Rehabilitation. |
| Usual Care | Active comparator | Behavioral: Usual Care |
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 on the date of randomization
- Patient implanted with a new HeartMate 3 LVAD at URMC
- Patients enrolling in the study at the time of index discharge home following new HM3 LVAD implantation will be evaluated by a HF cardiologist and physical therapist and will need to demonstrate ability to ambulate independently. Patients enrolling in the study after their index discharge home following HM3 LVAD implantation will be evaluated by a HF cardiologist or VAD Coordinator and will need to demonstrate ability to ambulate independently.
- Patient willing to participate in HER.
- Patient owns a smartphone with Internet connection.
Key exclusion criteria (6 listed)
- Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated HF, uncontrolled arrhythmias, unstable angina).
- Patient with a life expectancy <12 months.
- Patient unwilling to sign the consent for participation.
- Patient unwilling or unable to cooperate with the study protocol
- Patient who does not anticipate being a resident of the area for the scheduled duration of the research study
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 |
|---|---|---|
| Home-based Exercise Rehabilitation.Based on physical therapist or exercise physiologist assessment, subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strength training (including exercises using light-weight hand-weights and upper and lower body exercises using resistance bands). Research team will provide updated exercise prescription based on Garmin watch/Datos app activity data and Datos app data (including Borg scale). | Behavioural | Home-based Exercise Rehabilitation |
| Usual CarePatients receive a standardized recommendation to increase their walking activity to 30 minutes 5 days/week. | Behavioural | Usual Care |
Primary outcome
Mean number of clinic visits
Time frame: 1 year
Healthcare utilization will be measured as the sum of all-cause rehospitalizations, outpatient VAD Clinic visits and emergency room visits room visits
4 secondary outcomes
Mean number of days out of the hospital
Time frame: 1 year
Mean change in the number of daily steps taken
Time frame: 1 year
Mean change 6-minute walk distance
Time frame: baseline to 1 year
Mean change in number of participants with improved quality of life
Time frame: baseline to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Exercise Rehabilitation. in people with Heart Failure and Left Ventricular Dysfunction, run by University of Rochester at 1 site 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 6 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: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of clinic visits (time frame: 1 year). 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 8 Nov 2023.