Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
HF, rehabilitation
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.
Interventions
DEVICENeuromuscular electrical stimulation
Bilateral quadriceps muscle stimulation
Sponsors
University of Vermont Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Distance (6MW) | Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery | Change from Hospital Discharge (Within 1 day) to 4-weeks post-discharge | 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. |
| Katz Index of Independence in Activities of Daily Living | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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. |
| Medical Outcomes Short Form 36 | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 Question 1 | Hospital discharge (Within 1 day) and 4-weeks post-discharge | Responses to Q1. In general, would you say your health is: |
| Medical Outcomes Short Form 36 Question 2 | Hospital discharge (Within 1 day) and 4-weeks post-discharge | Responses to Q2. Compared to one year ago, how would you rate your health in general now? |
| Medical Outcomes Short Form 36 Question 3a | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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. |
| Medical Outcomes Short Form 36 Question 3b | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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. |
| Medical Outcomes Short Form 36 Question 3c | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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. |
| Medical Outcomes Short Form 36 Question 3d | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 3e | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 3f | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 3g | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 3h | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 3i | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 3j | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 4a | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 4b | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 4c | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 4d | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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) |
| Medical Outcomes Short Form 36 Question 5a | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 5b | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 5c | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 6 | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 7 | Hospital discharge (Within 1 day) and 4-weeks post-discharge | Responses to Q7. How much bodily pain have you had during the past four weeks? |
| Medical Outcomes Short Form 36 Question 8 | Hospital discharge (Within 1 day) and 4-weeks post-discharge | Responses to Q8. During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? |
| Medical Outcomes Short Form 36 Question 9a | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9b | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9c | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9d | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9e | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9f | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9g | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9h | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9i | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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? |
| Medical Outcomes Short Form 36 Question 9j | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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.)? |
| Medical Outcomes Short Form 36 Question 10a | Hospital discharge (Within 1 day) and 4-weeks post-discharge | 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 |
| Medical Outcomes Short Form 36 Question 10b | Hospital discharge (Within 1 day) and 4-weeks post-discharge | How TRUE or FALSE is each of the following statements for you: Responses to Q10b. I am as healthy as anybody I know |
| Medical Outcomes Short Form 36 Question 10c | Hospital discharge (Within 1 day) and 4-weeks post-discharge | How TRUE or FALSE is each of the following statements for you: Responses to Q10c. I expect my health to get worse |
| Medical Outcomes Short Form 36 Question 10d | Hospital discharge (Within 1 day) and 4-weeks post-discharge | How TRUE or FALSE is each of the following statements for you: Responses to Q10d. My health is excellent |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 80 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
None listed