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)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Device: Neuromuscular electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular electrical stimulation; Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week	Device: Neuromuscular electrical stimulation; Bilateral quadriceps muscle stimulation
No Intervention: Control; No treatment control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery	Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.	Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
Medical Outcomes Short Form 36	The Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This measure represents the total computed score across all sub-domains. Lower scores represent worse overall health, while higher scores represent better health.	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Katz Index of Independence in Activities of Daily Living	The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. Clinicians typically use the tool to detect problems in performing activities of daily living and to plan care accordingly. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Lawton Instrumental Activities of Daily Living (IADL) Scale	The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering have been excluded. Since men regularly complete food preparation, housekeeping, and laundering tasks, they were scored in all 8 domains as well. Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and men.	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 1	Responses to Q1. In general, would you say your health is:	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 2	Responses to Q2. Compared to one year ago, how would you rate your health in general now?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3a	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports.	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3b	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf.	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3c	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3c. Lifting or carrying groceries.	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3d	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3d. Climbing several flights ofstairs	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3e	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3e. Climbing one flight of stairs	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3f	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3f. Bending, kneeling, or stooping	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3g	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3g. Walking more than a mile	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3h	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3h. Walking several blocks	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3i	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3i. Walking one block	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3j	The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3j. Bathing or dressing yourself	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4a	During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4a. Cut down the amount of time you spent on work or other activities	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4b	During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4b. Accomplished less than you would like	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4c	During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4c. Were limited in the kind of work or other activities	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4d	During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4d. Had difficulty performing the work or other activities (for example, it took extra effort)	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 5a	During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5a. Cut down the amount of time you spent on work or other activities	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 5b	During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5b. Accomplished less than you would like	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 5c	During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5c. Didn't do work or other activities as carefully as usual	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 6	Responses to Q6. During the past 4weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 7	Responses to Q7. How much bodily pain have you had during the past four weeks?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 8	Responses to Q8. During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9a	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9a. Did you feel full of pep?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9b	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9b. Have you been a very nervous person?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9c	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9c. Have you felt so down in the dumps that nothing could cheer you up?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9d	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9d. Have you felt calm and peaceful?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9e	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9e. Did you have a lot of energy?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9f	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9f. Have you felt down hearted and blue?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9g	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9g. Did you feel worn out?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9h	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9h. Have you been a happy person?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9i	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9i. Did you feel tired?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9j	These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks... Responses to Q9j. During the past 4weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10a	How TRUE or FALSE is each of the following statements for you: Responses to Q10a. I seem to get sick a little easier than other people	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10b	How TRUE or FALSE is each of the following statements for you: Responses to Q10b. I am as healthy as anybody I know	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10c	How TRUE or FALSE is each of the following statements for you: Responses to Q10c. I expect my health to get worse	Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10d	How TRUE or FALSE is each of the following statements for you: Responses to Q10d. My health is excellent	Hospital discharge (Within 1 day) and 4-weeks post-discharge

Collaborators and Investigators

• Sponsor: University of Vermont Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: HF, rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: STUDY00001757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No