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Heart Failure With Preserved Ejection FractionNeuHFRecoverNCT05338437

NMES in HF Patients to Improve Functional Recovery Following Hospitalization

A study testing Neuromuscular electrical stimulation in people with Heart Failure With Preserved Ejection Fraction, run by University of Vermont Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
Neuromuscular electrical stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
7 Feb 2022to 30 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • University of Vermont Medical Center

    Burlington, Vermont, 05405

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Neuromuscular electrical stimulation
Keywords
HF, rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular electrical stimulationDevice

    Bilateral quadriceps muscle stimulation

Study groups in NCT05338437
Study groupRoleWhat they receive
Neuromuscular electrical stimulationExperimentalNeuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week
Receives: Device: Neuromuscular electrical stimulation
ControlNo interventionNo treatment control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge

Secondary outcomes (40)
  1. 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.

    Measured: Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge

  2. 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.

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  3. 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.

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  4. 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.

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  5. Medical Outcomes Short Form 36 Question 1

    Responses to Q1. In general, would you say your health is:

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  6. Medical Outcomes Short Form 36 Question 2

    Responses to Q2. Compared to one year ago, how would you rate your health in general now?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  7. 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.

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  8. 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.

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  9. 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.

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  10. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  11. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  12. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  13. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  14. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  15. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  16. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  17. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  18. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  19. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  20. 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)

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  21. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  22. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  23. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  24. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  25. Medical Outcomes Short Form 36 Question 7

    Responses to Q7. How much bodily pain have you had during the past four weeks?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  26. 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)?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  27. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  28. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  29. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  30. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  31. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  32. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  33. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  34. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  35. 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?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  36. 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.)?

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  37. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  38. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  39. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

  40. 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

    Measured: Hospital discharge (Within 1 day) and 4-weeks post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start7 Feb 2022
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338437
Sponsor's protocol ID
STUDY00001757
Acronym
NeuHFRecover
Status last verified
Apr 2025
First submitted
21 Mar 2022
Last updated
10 Jun 2026
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular electrical stimulation in people with Heart Failure With Preserved Ejection Fraction, run by University of Vermont Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minute Walk Distance (6MW) (time frame: Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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