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NCT03615469 · ClinicalTrials.gov registry record · NA
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT03615469 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 15 participants.
The verdict
NCT03615469, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
In the U.S., 5.7 million people have heart failure (HF), 915,000 new cases are diagnosed each year, and both incidence and prevalence are increasing due to the aging of the population and to better survival from ischemic heart disease. A hallmark of HF, is poor functional status that, characteristically, deteriorates as the condition progresses, negatively affecting patients' quality of life. Poor functional status is associated with increased risk of hospitalization for exacerbations of HF and with increased mortality. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of HF management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing HF symptoms and hospitalizations in patients with HF. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity. In this study, we propose to use neuromuscular electrical stimulation (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance. NMES has been shown to improve muscle strength, exercise capacity and quality of life, in samples less than 20 of male patients with HF. Larger sample studies are needed to demonstrate efficacy of this practice to jump start patients' abilities to benefit from formalized exercise program. The purpose of this double blinded, randomized, controlled, longitudinal study is to determine if NMES will increase muscle mass and strength, decrease sedentary time, and improve HF symptoms and exercise capacity, thus improving quality of life in patients with HF. It is hypothesized that with this increase in muscle mass, patients will improve overall exercise tolerance and capacity. In addition, a
Interventions
- DEVICE Neuromuscular electrical stimulation
- DEVICE Transcutaneous electrical stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2020-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03615469
The ClinicalTrials.gov registry entry for NCT03615469 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Neuromuscular electrical stimulation is the first listed.
NCT03615469 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03615469 about?
NCT03615469 is a clinical study titled "Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)". In the U.S., 5.7 million people have heart failure (HF), 915,000 new cases are diagnosed each year, and both incidence and prevalence are increasing due to the aging of the population and to better survival from ischemic heart disease. A hallmark of HF, is poor functional status that, characteristic...
What is the current status of trial NCT03615469?
This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2018-09-06. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT03615469?
The interventions under investigation include: Neuromuscular electrical stimulation (DEVICE), Transcutaneous electrical stimulation (DEVICE).
Who is sponsoring clinical trial NCT03615469?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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