Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Terminated Not applicable Interventional Results available

Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)

ClinicalTrials.gov ID: NCT03615469

Public ClinicalTrials.gov record NCT03615469. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Building Strength Through Rehabilitation for Heart Failure Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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, after the intervention patients will be better able to tolerate an exercise program thus improving adherence to exercise recommendations. After 6 weeks of intervention, patients will be encouraged to participate in a formalized exercise program.

Study identification

NCT ID
NCT03615469
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
Indiana University
Other
Enrollment
15 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 5, 2018
Primary completion
Jun 30, 2020
Completion
Nov 30, 2020
Last update posted
May 30, 2023

2018 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Indiana University Indianapolis Indiana 46202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03615469, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 30, 2023 · Synced Sep 2, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03615469 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →