NMES in HF Patients to Improve Functional Recovery Following Hospitalization

NCT ID: NCT05338437

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2023-09-30

Brief Summary

The goal of this research study is to understand whether an at-home exercise program started after hospitalization for HFpEF, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.

Detailed Description

Heart failure is the leading cause of hospitalization among adults in the US with patients with preserved ejection fraction (HFpEF) comprising half of those admissions. Many patients exhibit chronic fatigue, exercise intolerance and an inability to perform activities of daily living, which is exacerbated by hospitalization. The goal of this research study is to understand whether an at-home exercise program started soon after hospitalization and continuing for 4 weeks following discharge can improve functional recovery in HFpEF patients. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated during hospitalization and 4 weeks following discharge. Assessments will include measurements of physical function by 6 minute walk test and the Short Physical Performance Battery, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36 and Kansas City Cardiomyopathy questionnaire.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Neuromuscular electrical stimulation

Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: DEVICE

Bilateral quadriceps muscle stimulation

Control

No treatment control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neuromuscular electrical stimulation

Bilateral quadriceps muscle stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 50-90 years of age
• clinical diagnosis of HF being actively managed during hospitalization
• live within 30 miles of the medical center
• able to perform informed consent

Exclusion Criteria

• rheumatoid arthritis or other inflammatory/autoimmune disease
• cancer, excluding non-melanoma skin cancer or low-grade prostate cancer
• severe dementia/alzheimer's disease
• exercise limiting peripheral vascular disease
• neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event
• body mass index ≥40 kg/m2
• lower extremity blood clot or implantable cardioverter-defibrillator or pacemaker

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sherrie Khadanga

Associate Director Cardiac Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00001757

Identifier Type: -

Identifier Source: org_study_id