Clinical Trials Logo

Clinical Trial 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, 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03615469
Study type Interventional
Source Indiana University
Contact Christine Haedtke, PhD
Phone 317-274-5358
Email chaedtke@iu.edu
Status Recruiting
Phase N/A
Start date September 6, 2018
Completion date December 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT03087084 - RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF) N/A
Recruiting NCT03300791 - Predictive Models of Readmission in Heart Failure N/A
Completed NCT03294512 - Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform N/A
Recruiting NCT03565328 - The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects Phase 2
Recruiting NCT03560167 - Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study N/A
Not yet recruiting NCT03647891 - Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients N/A
Recruiting NCT03281122 - A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction Phase 1
Recruiting NCT02275819 - Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Completed NCT03238729 - Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure N/A
Not yet recruiting NCT03360448 - AC6 Gene Transfer in Patients With Reduced Left Ventricular Ejection Fraction Heart Failure Phase 3
Not yet recruiting NCT03587064 - Comparison of CRT-D and CRT-DX Systems (CRT-NEXT) N/A
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Recruiting NCT03013270 - Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure N/A
Recruiting NCT02823795 - The Supporting Patient Activation in Transition to Home Intervention N/A
Recruiting NCT02911493 - Reducing Sedentary Time in Patients With Heart Failure N/A
Recruiting NCT02674438 - Comparison of Outcomes and Access to Care for Heart Failure Trial Phase 3
Recruiting NCT02713126 - Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) Phase 2
Recruiting NCT02877914 - China PEACE 5r-HF Study N/A