Heart Failure With Preserved Ejection FractionMOBILE HEARTNCT06479876
Home-Based Cardiac Rehabilitation for Patients With Heart Failure
A study testing HBCR in people with Heart Failure With Preserved Ejection Fraction and Heart Failure With Reduced Ejection Fraction, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Cardiovascular Diseases
- What is being tested?
- HBCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to Aug 2027
- 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
- Stage C HF (NYHA Class I-III) AND
- Discharged from a HF hospitalization OR
- Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
- Scheduled for appointment in a cardiology clinic with a KCCQ-SS <75
- Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase
- Randomized Controlled Trial (beyond roll-in phase)
- 1. Willingness to continue and participate in the study visits and other study activities required for the RCT
Who cannot join
- Unwilling or unable to provide informed consent for participation in the RCT
- Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
- If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
- History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
- Age < 18 years
- Stage D HF (advanced HF under evaluation for LVAD or transplant)
Show all 19Show fewer
- NYHA class IV symptoms
- Congenital heart disease
- Pregnant
- Group 1 pulmonary hypertension
- Moderate-severe or severe (> 3+) mitral or aortic valvular disease
- Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
- Planned surgery within 3 months
- Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
- Treating provider or study team physician indicates that participation in the RCT would be unsafe
- Participation in any ongoing randomized trial that has not completed follow-up
- Randomized Controlled Trial (beyond roll-in phase)
- Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device >9 hours/day for at least 1 day.
- Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial
The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Cardiovascular Diseases
- Being tested
- HBCR
- Keywords
- cardiac rehabilitation, physical activity, functional capacity, quality of life, outcomes
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBCROther
Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist.
| Study group | Role | What they receive |
|---|---|---|
| Home-based cardiac rehabilitation mobile health intervention | Experimental | Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets. Receives: Other: HBCR |
| Control | No intervention | Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily total activity counts
Daily total activity counts are determined by a triaxial actigraphy device.
Measured: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.
Secondary outcomes (26)
Average daily active minutes
Daily active minutes are determined by a triaxial actigraphy device.
Measured: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.
Average daily steps
Daily steps are determined by a triaxial actigraphy device.
Measured: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
Average daily energy expenditure
Average daily energy expenditure is determined by a triaxial actigraphy device.
Measured: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.
Average daily moderate to vigorous active minutes
Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.
Measured: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.
Sustained physical activity bursts of 10 minutes or greater per day
Physical activity bursts are determined by a triaxial actigraphy device.
Measured: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
6 minute walk distance
The distance walked in 6 minutes.
Measured: The comparison will be at 12-weeks after randomization.
Chair sit to stand time
The time taken to complete 5 chair rises.
Measured: The comparison will be at 12-weeks after randomization.
5 meter gait speed
The speed of walking 5 meters (meters/second).
Measured: The comparison will be at 12-weeks after randomization.
Balance test
Score based on ability to stand unsupported for 10 seconds with feet in a certain position (feet together, semi tandem, full tandem). Score ranges from 0-4 (higher score is better).
Measured: The comparison will be at 12-weeks after randomization.
AM-PAC Basic Mobility Outpatient Short Form (Low Function)
Basic mobility will be assessed with the Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Short Form (Low Function); (raw score range 0-39, higher score is better)
Measured: The comparison will be at 12-weeks after randomization.
Short Physical Performance Battery Score
Composite score including 3 components (Chair sit to stand, 5 meter gait speed, balance test). Score ranges from 0-12 (higher score is better).
Measured: The comparison will be at 12-weeks after randomization.
Heart-failure specific health status assessed by the KCCQ
Assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ); (score range 0-100, higher is better health status).
Measured: The comparison will be at 12-weeks after randomization.
Physical health status assessed by the PROMIS 10
Global physical health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20, higher is better).
Measured: The comparison will be at 12-weeks after randomization.
Mental health status assessed by the PROMIS 10
Global mental health score from the PROMIS 10 Global Health Short Form questionnaire (raw score range 4-20, higher is better)
Measured: The comparison will be at 12-weeks after randomization.
Mood disturbance assessed by PHQ9
Patient health questionnaire 9 (PHQ9); (score range 1-27, lower is better)
Measured: The comparison will be at 12-weeks after randomization.
Behavioral Regulation In Exercise Questionnaire 3
Behavioral Regulation In Exercise Questionnaire 3 (BREQ-3); (score range per question of 0-4, higher is better).
Measured: The comparison will be at 12-weeks after randomization.
Social support and exercise survey
Social support and exercise survey (score range per question of 1-5, higher is better).
Measured: The comparison will be at 12-weeks after randomization.
Multidimensional Self-Efficacy for Exercise Scale
Multidimensional Self-Efficacy for Exercise Scale (MSES); (score range per question of 0-10, higher is better).
Measured: The comparison will be at 12-weeks after randomization.
General self-efficacy scale
General self-efficacy scale (GSE); (score range per question of 1-4, higher is better).
Measured: The comparison will be at 12-weeks after randomization.
Blood pressure
Measured: The comparison will be at 12-weeks after randomization.
Modified Heart Failure Collaborative GDMT score
Guideline directed medical therapy (GDMT) score includes 4 components of RAASi, BB, SGLT2i, and MRA (maximum score of 9, higher scores indicate increased GDMT utilization).
Measured: The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less.
Probability of the hierarchical clinical event composite
The hierarchical clinical event composite includes (in order of hierarchy): (1) all-cause death and (2) all-cause hospitalization. To examine whether the intervention improves mortality and hospitalization, in heart failure patients, we will conduct Bayesian Markov longitudinal proportional odds model on weekly outcome measures. The active treatment vs. control group comparison (primary comparison for the trial) will be estimated by contrasting the average of posterior probability that Y≥y of the active treatment group to the control group.
Measured: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
All-cause unplanned rehospitalization
This includes inpatient, observation, or ER visit.
Measured: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
Worsening heart failure event
This includes inpatient, observation, ER visit, or urgent clinic visit for worsening heart failure.
Measured: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
All-cause mortality
Death for any reason.
Measured: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
"Thriving patient" composite
Percent of patients that meet the following criteria: 1) alive 2) no all-cause hospitalization 3) Improvement in average daily total activity counts by 10% or greater from baseline to 12 weeks.
Measured: The comparison will be made at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start5 Aug 2024
- Primary completionJan 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Model description
- Participants randomized 1:1 to 2 groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Lindman, Vanderbilt University Medical Center
- Investigators
- Brian R Lindman, MD, MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479876
- Sponsor's protocol ID
- 240749
- Acronym
- MOBILE HEART
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2024
- Last updated
- 2 Oct 2026
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06479876
- Acronym / sponsor ID
- MOBILE HEART / 240749
- Conditions
- Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Cardiovascular Diseases
- Keywords
- cardiac rehabilitation, physical activity, functional capacity, quality of life, outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 28 Jun 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 vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomized 1:1 to 2 groups.
| Arm | Type | Receives |
|---|---|---|
| Home-based cardiac rehabilitation mobile health intervention | Experimental | Other: HBCRHome-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets. |
| Control | No intervention | –Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage C HF (NYHA Class I-III) AND
- Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase
- Randomized Controlled Trial (beyond roll-in phase)
- 1. Willingness to continue and participate in the study visits and other study activities required for the RCT
Key exclusion criteria (19 listed)
- Unwilling or unable to provide informed consent for participation in the RCT
- Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
- If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
- History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
- Age < 18 years
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 |
|---|---|---|
| HBCRHome-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist. | Other | Home-based cardiac rehabilitation mobile health intervention |
Primary outcome
Average daily total activity counts
Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.
Daily total activity counts are determined by a triaxial actigraphy device.
26 secondary outcomes
Average daily active minutes
Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.
Average daily steps
Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
Average daily energy expenditure
Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.
Average daily moderate to vigorous active minutes
Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.
Sustained physical activity bursts of 10 minutes or greater per day
Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.
6 minute walk distance
Time frame: The comparison will be at 12-weeks after randomization.
Chair sit to stand time
Time frame: The comparison will be at 12-weeks after randomization.
5 meter gait speed
Time frame: The comparison will be at 12-weeks after randomization.
Balance test
Time frame: The comparison will be at 12-weeks after randomization.
AM-PAC Basic Mobility Outpatient Short Form (Low Function)
Time frame: The comparison will be at 12-weeks after randomization.
Short Physical Performance Battery Score
Time frame: The comparison will be at 12-weeks after randomization.
Heart-failure specific health status assessed by the KCCQ
Time frame: The comparison will be at 12-weeks after randomization.
Physical health status assessed by the PROMIS 10
Time frame: The comparison will be at 12-weeks after randomization.
Mental health status assessed by the PROMIS 10
Time frame: The comparison will be at 12-weeks after randomization.
Mood disturbance assessed by PHQ9
Time frame: The comparison will be at 12-weeks after randomization.
Behavioral Regulation In Exercise Questionnaire 3
Time frame: The comparison will be at 12-weeks after randomization.
Social support and exercise survey
Time frame: The comparison will be at 12-weeks after randomization.
Multidimensional Self-Efficacy for Exercise Scale
Time frame: The comparison will be at 12-weeks after randomization.
General self-efficacy scale
Time frame: The comparison will be at 12-weeks after randomization.
Blood pressure
Time frame: The comparison will be at 12-weeks after randomization.
Modified Heart Failure Collaborative GDMT score
Time frame: The comparison will be at 12-weeks after randomization in patients with LVEF of 40% or less.
Probability of the hierarchical clinical event composite
Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
All-cause unplanned rehospitalization
Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
Worsening heart failure event
Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
All-cause mortality
Time frame: Over the entire available follow-up period for randomized participants (minimum of 12 weeks).
"Thriving patient" composite
Time frame: The comparison will be made at 12 weeks.
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 2 Oct 2026.
- 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.
Brian R Lindman, MD, MSCI principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBCR in people with Heart Failure With Preserved Ejection Fraction and Heart Failure With Reduced Ejection Fraction, run by Vanderbilt University Medical Center 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 7 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 2 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 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?
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?
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?
Average daily total activity counts (time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.). 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 2 Oct 2026.