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MOVE-HF MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction

MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction (MOVE-HF)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Travel or expenses covered

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will be asked to use the wearable device during the day every day during the intervention and follow-up periods."
Compensation
Travel or expenses covered
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether game-like activities with social support or competition help adults with heart failure stay physically active. It is for people with HFpEF, a type of heart failure in which the heart still pumps out a normal share of blood. The study includes 2 weeks of starting measurements, a 6-month program, and 3 months of follow-up.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have HFpEF and an ejection fraction of at least 50%. This means the heart pumps out at least half the blood in its main pumping chamber with each beat.
  • Meet at least one of these checks: a past hospital stay mainly for HFpEF; a BNP blood test above 75 pg/mL (above 225 pg/mL if you have atrial fibrillation, an irregular heartbeat); an H2FPEF heart failure score of at least 5; or high pressure on a right-heart tube test (at least 15 mm Hg at rest or 25 mm Hg during exercise).
  • Own a smartphone or tablet that can connect to the internet.
  • Be able to read English.
  • Be able to understand the study and give consent to join.

Who can't join

  • You are in another study that tests a physical activity program.
  • A health condition keeps you from walking without help or taking part in exercise. A cane is allowed, but other walking aids are not.
  • A 9-month physical activity program would be unsafe or not possible for you.
  • You have a heart or blood vessel procedure planned, such as a stent or surgery.
  • At the start, you walk more than 7,500 steps a day or fewer than 1,000 steps a day.
  • You have dementia, kidney failure treated with dialysis, or cirrhosis (serious liver scarring).
  • You had heart surgery or a heart valve replaced through a tube within the past year.
  • You have severe narrowing of the aortic or mitral heart valve.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Study sites (1)

PA