Clinical trial NCT05338437: NMES in HF Patients to Improve Functional Recovery Following Hospitalization
Official title: Neuromuscular Electrical Stimulation in Heart Failure Patients to Improve Functional Recovery Following Hospitalization (NeuHF-Recover)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: HF, rehabilitation
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 6 Minute Walk Distance (6MW)
timeFrame: Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
measure: Medical Outcomes Short Form 36
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Role Emotional
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Social Function
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Vitality
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - General Health
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Bodily Pain
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Medical Outcome Short Form 36 - Role Physical
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Physical Function
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Katz Index of Independence in Activities of Daily Living
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
measure: Lawton Instrumental Activities of Daily Living (IADL) Scale
timeFrame: Hospital discharge (Within 1 day) and 4-weeks post-discharge
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References: