Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials.
Study Goal
The researchers aimed to determine whether a pedometer-based walking intervention improves functional capacity and neurohumoral modulation in patients with chronic heart failure (both reduced and preserved ejection fraction).
Results Summary
The study is ongoing, but the abstract suggests that walking is a popular, effective, and safe form of physical activity for heart failure patients, with primary and secondary outcomes focused on functional capacity, biomarkers, and quality of life.
Population
Patients with chronic heart failure (HFrEF and HFpEF) who are physically inactive.
Effective Dosage
Individualized pedometer-based walking program with weekly step goals (specific step count not provided).
Duration
6-month intervention with follow-up assessments at 3 months, 6 months, and 6 months post-intervention.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
regular physical activity | increase | functional capacity | patients with chronic heart failure | - | recommended to improve | #1 |
walking | neutral | physical activity | patients with chronic heart failure | - | popular, effective, and safe form | #2 |
pedometers | increase | amount of walking | patients across a range of chronic diseases | - | have shown potential to increase | #3 |
pedometer-based intervention | increase | functional capacity | heart failure patients | - | unknown whether improves | #4 |
pedometer-based intervention | increase | neurohumoral modulation | heart failure patients | - | unknown whether improves | #5 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | change in 6-min walk distance | physically inactive participants with chronic heart failure | - | will be evaluated | #6 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | changes in serum biomarkers levels | physically inactive participants with chronic heart failure | - | will be evaluated | #7 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | pulmonary congestion assessed by ultrasound | physically inactive participants with chronic heart failure | - | will be evaluated | #8 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | average daily step count measured by accelerometry | physically inactive participants with chronic heart failure | - | will be evaluated | #9 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | anthropometric measures | physically inactive participants with chronic heart failure | - | will be evaluated | #10 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | symptoms of depression | physically inactive participants with chronic heart failure | - | will be evaluated | #11 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | health-related quality of life | physically inactive participants with chronic heart failure | - | will be evaluated | #12 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | self-efficacy | physically inactive participants with chronic heart failure | - | will be evaluated | #13 |
individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse | neutral | MAGGIC risk score | physically inactive participants with chronic heart failure | - | will be evaluated | #14 |
BACKGROUND: Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients. METHODS: Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). The primary outcome is the change in 6-min walk distance at the end of the 6-month intervention. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC risk score. DISCUSSION: To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical activity promotion in heart failure patients to inform future physical activity recommendations and heart failure guidelines. Trial registration The trials are registered in ClinicalTrials.gov, identifiers: NCT03041610, registered 29 January 2017 (HFrEF), NCT03041376, registered 1 February 2017 (HFpEF).