HFpEF - Heart Failure With Preserved Ejection FractionNCT06670001
MOVE-HF MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction
A study testing Gamification plus social incentive and Gamification plus competition in people with HFpEF - Heart Failure With Preserved Ejection Fraction, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Gamification plus social incentive and Gamification plus competition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 31 Mar 2029
- Phase
- Interventional
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
- Adults (age ≥ 18 years) who: 1) have a diagnosis of heart failure with preserved ejection; 2) have an ejection fraction ≥ 50%; 3) meet ONE of the following criteria: any history of hospitalization with a primary diagnosis of heart failure with preserved ejection fraction, BNP > 75 pg/mL (> 225 pg/mL in patients with atrial fibrillation), H2FPEF score ≥ 5, OR elevated pulmonary capillary wedge pressure on right heart catheterization (≥ 15 mm Hg at rest or ≥ 25 mm Hg with exercise); 4) own a smartphone or tablet capable of connecting to the internet; 5) are able to read English; 6) are able to provide informed consent
Who cannot join
- Participants will be excluded if they are currently participating in another interventional physical activity study, have medical conditions prohibiting ambulation without assistance (including use of an assistive device other than a cane) or participation in an exercise program, if a 9-month physical activity program is infeasible or unsafe, upcoming cardiovascular procedures (e.g. stent or surgery) or if the patient is at a high level of physical activity (>7500 steps per day) or very low level of physical activity (< 1000 steps/day) at baseline. Patients taking > 7500 steps/day will be excluded based on data showing that increasing step count beyond 7500 steps/day does not improve outcomes in all-comer populations, and to ensure that we are recruiting a population of patients with symptomatic HF. Patients taking < 1000 steps/day at baseline will be excluded to ensure that we will not enroll very frail patients with a need for more intensive exercise training or physical therapy. To ensure that we are capturing patients who are limited in their exertional capacity by heart failure, we will also exclude patients with dementia, end-stage renal disease on dialysis, cirrhosis, cardiac surgery or transcatheter valve replacement within the last year, severe aortic stenosis or severe mitral stenosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chinyere Anucha contact
United States1 site, 1 recruiting
- Recruiting
The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Samantha Coratti, samantha.coratti@pennmedicine.upenn.edu
Alexander Fanaroff, MD, MHS
About this study
Official title: MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction (MOVE-HF)
This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. There will be a 2-week run-in period to obtain baseline measures of physical activity, followed by a 6-month intervention period and then a 3-month follow-up period.
Read the detailed description
Heart failure (HF) with preserved ejection fraction (HFpEF), a syndrome characterized by exercise intolerance due to breathlessness and fatigue, is a major public health problem rising in prevalence. No pharmacologic strategy has been shown to consistently improve functional capacity of HFpEF patients, though exercise training is beneficial. However, reimbursement barriers and access limitations preclude widespread implementation of cardiac rehabilitation. Despite the association between increased physical activity, lower HF hospitalization, and improved quality of life, physical activity levels remain dismally low in HF patients. This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. There will be a 2-week run-in period to obtain baseline measures of physical activity, followed by a 6-month intervention period and then a 3-month follow-up period. All participants will be asked to use the wearable device during the day every day during the intervention and follow-up periods. The three interventions by study arm will vary as follows: Control, Gamification plus social incentive which includes; Pre commitment, support partner, a game using; points, levels, fresh starts, trophies and automated coaching. Competition arm which includes; Pre commitment, a game using; points, levels, fresh starts, trophies and automated coaching and a competition with other participants and access to the leadership board.
- Being tested
- Gamification plus social incentive, Gamification plus competition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamification plus social incentiveBehavioural
Participants in the Gamification plus social incentive intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
Gamification plus competitionBehavioural
Participants in the Gamification plus competition intervention arm will receive gamification and a competition as part of the intervention. See arm descriptions for more detail.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In addition to using a wearable device, participants in the control arm will receive a daily notification of their step count from the previous day. |
| Gamification plus social incentive | Experimental | Participants will receive daily text messages on whether or not they hit their step goal.
Participants will be entered into a game, that runs for 6 months. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level.
They will receive twice-weekly motivational or educational text messages that highlight the effect of exercise on functional capacity in patients with HFpEF.
Participants will select a family member or friend who will serve as a support partner. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. The support partner will receive a weekly email reminding him/her of these approaches and updating him/her on the participant's progress including accumulated points, level in the game, and average step count. Receives: Behavioral: Gamification plus social incentive |
| Gamification plus competition | Experimental | Participants will receive daily text messages on whether or not they hit their step goal.
Participants will be entered into a game, that runs for 6 months. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level.
They will receive twice-weekly motivational or educational text messages that highlight the effect of exercise on functional capacity in patients with HFpEF. Participants will have access to a leaderboard that will include two other participants. Participants will be ranked on the leaderboard by total points over the course of the study. They will receive a weekly text message with their position on the leaderboard. Receives: Behavioral: Gamification plus competition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period.
The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period.
Measured: 9 months
Secondary outcomes (5)
Change in mean daily steps from baseline to through the 6-month intervention period
Change in mean daily steps from baseline to through the 6-month intervention period
Measured: 6 months
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 6-month intervention period
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 6-month intervention period
Measured: 6 months
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 3-month post-intervention follow-up period
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 3-month post-intervention follow-up period
Measured: 9 months
Change in six-minute walk distance from baseline through the 6-month intervention period
Change in six-minute walk distance from baseline through the 6-month intervention period
Measured: 6 months
Change in six-minute walk distance from baseline through the 3-month post-intervention follow-up period
Change in six-minute walk distance from baseline through the 3-month post-intervention follow-up period
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start5 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 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
- Alexander Fanaroff, MD, MHS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670001
- Sponsor's protocol ID
- 855906
- Other IDs
- 1R01HL174691
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No