NMES in HF Patients to Improve Functional Recovery Following Hospitalization
NeuHFRecover
Neuromuscular Electrical Stimulation in Heart Failure Patients to Improve Functional Recovery Following Hospitalization (NeuHF-Recover)
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2022
CompletedFirst Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedNovember 25, 2024
November 1, 2024
1.6 years
March 21, 2022
November 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
6 Minute Walk Distance (6MW)
6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in heart failure patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course.
Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
Secondary Outcomes (11)
Short Physical Performance Battery
Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
Medical Outcomes Short Form 36
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 - Role Emotional
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 - Social Function
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 - Vitality
Hospital discharge (Within 1 day) and 4-weeks post-discharge
- +6 more secondary outcomes
Study Arms (2)
Neuromuscular electrical stimulation
EXPERIMENTALNeuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week
Control
NO INTERVENTIONNo treatment control
Interventions
Bilateral quadriceps muscle stimulation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont Medical Center
Burlington, Vermont, 05405, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director Cardiac Rehabilitation
Study Record Dates
First Submitted
March 21, 2022
First Posted
April 21, 2022
Study Start
February 7, 2022
Primary Completion
September 30, 2023
Study Completion
September 30, 2023
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share