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NMES in HF Patients to Improve Functional Recovery Following Hospitalization (NeuHFRecover)

U

University of Vermont Medical Center

Status

Completed

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Device: Neuromuscular electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05338437
STUDY00001757

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

9 participants in 2 patient groups

Neuromuscular electrical stimulation
Experimental group
Description:
Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week
Treatment:
Device: Neuromuscular electrical stimulation
Control
No Intervention group
Description:
No treatment control

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Sherrie Khadanga, MD

Data sourced from clinicaltrials.gov

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