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Rehabilitation and Exercise Training after Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) pilot is a multi-site, randomized clinical pilot study designed to establish the feasibility of conducting a larger clinical trial to address the hypothesis that, in addition to standard care, a novel, progressive, multi-domain 3-month rehabilitation intervention administered to elderly patients with acute decompensated heart failure (ADHF) will improve key clinical outcomes, including the rate of rehospitalization and death, physical function, and quality of life.
Three centers,Wake Forest Baptist Health along with Thomas Jefferson University Hospital-Co-Investigator Dr. David Whellan, and Duke Medical Center- Co-Investigator Dr. Christopher O'Connor, will recruit a total of 60 consenting patients ≥ 60 years old hospitalized with ADHF. Once identified and screened, the participants will be randomized in a 1:1 fashion to receive a 3 month novel rehabilitation and exercise training intervention or usual care. This multi-domain intervention will include endurance, mobility, strength, and balance training and be tailored based on participant performance in each of these domains. It will begin during the hospitalization and continue three times per week in an outpatient facility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | Active Comparator | Usual care control group |
|
| Active Comparator | Active Comparator | Multi domain rehabilitation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Behavioral | Usual care control group |
| |
| Rehabilitation intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test | The 6 minute walk test submaximal exercise test that measures how far a participant can walk in 6 continuous minutes. Participants are instructed to walk as far as possible in 6 minutes, and are allowed to slow down and take breaks as needed due to symptoms. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| SPPB (Short Physical Performance Battery) | The SPPB is a multi-component measure of physical function. The SPPB is composed of 3 components-standing balance, gait speed, and timed repeated chair rise-each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. A higher score denotes better physical function. | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalane W Kitzman, MD | Wake Forest Baptist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Medical Center | Durham | North Carolina | 27710 | United States | ||
| Wake Forest Baptist Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28285121 | Derived | Reeves GR, Whellan DJ, O'Connor CM, Duncan P, Eggebeen JD, Morgan TM, Hewston LA, Pastva A, Patel MJ, Kitzman DW. A Novel Rehabilitation Intervention for Older Patients With Acute Decompensated Heart Failure: The REHAB-HF Pilot Study. JACC Heart Fail. 2017 May;5(5):359-366. doi: 10.1016/j.jchf.2016.12.019. Epub 2017 Mar 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention | Usual care control group |
| FG001 | Active Comparator | Multi domain rehabilitation intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention | Usual care control group |
| BG001 | Active Comparator | Multi domain rehabilitation intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6 Minute Walk Test | The 6 minute walk test submaximal exercise test that measures how far a participant can walk in 6 continuous minutes. Participants are instructed to walk as far as possible in 6 minutes, and are allowed to slow down and take breaks as needed due to symptoms. | Posted | Least Squares Mean | Standard Error | meters | up to 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Intervention | Usual care control group | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rehospitalization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED visit | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dalane Kitzman | Wake Forest School of Medicine | 336-716-2227 | dkitzman@wakehealth.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Behavioral |
Multi-domain rehabilitation intervention |
|
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | SPPB (Short Physical Performance Battery) | The SPPB is a multi-component measure of physical function. The SPPB is composed of 3 components-standing balance, gait speed, and timed repeated chair rise-each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. A higher score denotes better physical function. | Posted | Least Squares Mean | Standard Error | units on a scale | up to 3 months |
|
|
|
| 12 |
| 8 |
| 12 |
| 2 |
| 12 |
| EG001 | Active Comparator | Multi domain rehabilitation intervention | 0 | 15 | 11 | 15 | 5 | 15 |
| Rehospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rehospitalization | General disorders | Systematic Assessment |
|
| Rehospitalization | Renal and urinary disorders | Systematic Assessment |
|
| Rehospitalization | Surgical and medical procedures | Systematic Assessment |
|
| Rehospitalization | Gastrointestinal disorders | Systematic Assessment |
|
| Rehospitalization | Nervous system disorders | Systematic Assessment |
|
| Rehospitalization | Infections and infestations | Systematic Assessment |
|
| ED visit | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ED visit | General disorders | Systematic Assessment |
|
| Urgent Care Visit | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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