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

Primary Purpose

Heart Failure With Preserved Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sponsored by
University of Vermont Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure With Preserved Ejection Fraction focused on measuring HFpEF

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 50-90 years of age
  • clinical diagnosis of HFpEF 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

Sites / Locations

  • University of Vermont Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neuromuscular electrical stimulation

Control

Arm Description

Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week

No treatment control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Medical Outcomes Short Form 36 - Role Emotional
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 sub-domain focuses on limitations in usual role activities because of emotional problems. Lower scores represent more limitations, while higher scores represent less limitations.
Medical Outcomes Short Form 36 - Social Function
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 sub-domain focuses on limitations in social activities because of physical or emotional problems. Lower scores represent more more limitations, while higher scores represent less limitations.
Medical Outcomes Short Form 36 - Vitality
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 sub-domain focused on vitality (energy and fatigue). Lower scores represent less vitality, while higher scores represent more vitality.
Medical Outcomes Short Form 36 - General Health
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Medical Outcomes Short Form 36 - Bodily Pain
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Medical Outcome Short Form 36 - Role Physical
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Medical Outcomes Short Form 36 - Physical Function
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
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.
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 are excluded. 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 0 through 5 for men.

Full Information

First Posted
March 21, 2022
Last Updated
April 13, 2022
Sponsor
University of Vermont Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05338437
Brief Title
NMES in HF Patients to Improve Functional Recovery Following Hospitalization
Acronym
NeuHFRecover
Official Title
Neuromuscular Electrical Stimulation in Heart Failure Patients to Improve Functional Recovery Following Hospitalization (NeuHF-Recover)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont Medical Center

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
HFpEF

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation of the quadriceps. 45 minutes, 5 days per week
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment control
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
Bilateral quadriceps muscle stimulation
Primary Outcome Measure Information:
Title
6 Minute Walk Distance (6MW)
Description
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.
Time Frame
Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
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.
Time Frame
Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge
Title
Medical Outcomes Short Form 36
Description
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.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Medical Outcomes Short Form 36 - Role Emotional
Description
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 sub-domain focuses on limitations in usual role activities because of emotional problems. Lower scores represent more limitations, while higher scores represent less limitations.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Medical Outcomes Short Form 36 - Social Function
Description
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 sub-domain focuses on limitations in social activities because of physical or emotional problems. Lower scores represent more more limitations, while higher scores represent less limitations.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Medical Outcomes Short Form 36 - Vitality
Description
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 sub-domain focused on vitality (energy and fatigue). Lower scores represent less vitality, while higher scores represent more vitality.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Medical Outcomes Short Form 36 - General Health
Description
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Medical Outcomes Short Form 36 - Bodily Pain
Description
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Medical Outcome Short Form 36 - Role Physical
Description
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Medical Outcomes Short Form 36 - Physical Function
Description
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 sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Katz Index of Independence in Activities of Daily Living
Description
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.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Title
Lawton Instrumental Activities of Daily Living (IADL) Scale
Description
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 are excluded. 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 0 through 5 for men.
Time Frame
Hospital discharge (Within 1 day) and 4-weeks post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50-90 years of age clinical diagnosis of HFpEF 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherrie Khadanga, MD
Phone
802-847-6317
Email
sherrie.khadanga@uvmhealth.org
Facility Information:
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherrie Khadanga
Phone
802-847-2700
Email
sherrie.khadanga@uvmhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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NMES in HF Patients to Improve Functional Recovery Following Hospitalization

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