REHAB-HF: Rehabilitation and Exercise Training After Hospitalization
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: No intervention Usual care control group |
Behavioral: Usual care
Usual care control group
|
| Active Comparator: Active Comparator Multi domain rehabilitation intervention |
Behavioral: Rehabilitation intervention
Multi-domain rehabilitation intervention
|
Outcome Measures
Primary Outcome Measures
- 6 Minute Walk Test [up to 3 months]
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.
Secondary Outcome Measures
- SPPB (Short Physical Performance Battery) [up to 3 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 60 years old
-
Hospitalized for the management of ADHF or diagnosed with ADHF after being hospitalized for another reason. ADHF will be defined as a combination of symptoms, signs, and HF-specific medical treatments.
Exclusion Criteria:
-
Planned discharge other than to home or a facility where the participant will live independently.
-
Acute myocardial infarction
-
Already participating in cardiac rehabilitation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Medical Center | Durham | North Carolina | United States | 27710 |
| 2 | Wake Forest Baptist Hospital | Winston-Salem | North Carolina | United States | 27157 |
| 3 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Wake Forest University
Investigators
- Principal Investigator: Dalane W Kitzman, MD, Wake Forest Baptist Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00016973
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | No Intervention | Active Comparator |
|---|---|---|
| Arm/Group Description | Usual care control group | Multi domain rehabilitation intervention |
| Period Title: Overall Study | ||
| STARTED | 12 | 15 |
| COMPLETED | 12 | 12 |
| NOT COMPLETED | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | No Intervention | Active Comparator | Total |
|---|---|---|---|
| Arm/Group Description | Usual care control group | Multi domain rehabilitation intervention | Total of all reporting groups |
| Overall Participants | 12 | 15 | 27 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
71.8
(10.8)
|
72.7
(9.1)
|
72.3
(9.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
66.7%
|
8
53.3%
|
16
59.3%
|
| Male |
4
33.3%
|
7
46.7%
|
11
40.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
8.3%
|
0
0%
|
1
3.7%
|
| Not Hispanic or Latino |
11
91.7%
|
15
100%
|
26
96.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
7
58.3%
|
8
53.3%
|
15
55.6%
|
| White |
5
41.7%
|
7
46.7%
|
12
44.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | 6 Minute Walk Test |
|---|---|
| Description | 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. |
| Time Frame | up to 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | No Intervention | Active Comparator |
|---|---|---|
| Arm/Group Description | Usual care control group | Multi domain rehabilitation intervention |
| Measure Participants | 12 | 12 |
| Least Squares Mean (Standard Error) [meters] |
224
(22)
|
247
(22)
|
| Title | SPPB (Short Physical Performance Battery) |
|---|---|
| Description | 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. |
| Time Frame | up to 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | No Intervention | Active Comparator |
|---|---|---|
| Arm/Group Description | Usual care control group | Multi domain rehabilitation intervention |
| Measure Participants | 12 | 12 |
| Least Squares Mean (Standard Error) [units on a scale] |
6.3
(0.5)
|
7.4
(0.5)
|
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | No Intervention | Active Comparator | ||
| Arm/Group Description | Usual care control group | Multi domain rehabilitation intervention | ||
All Cause Mortality |
||||
| No Intervention | Active Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/15 (0%) | ||
Serious Adverse Events |
||||
| No Intervention | Active Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/12 (66.7%) | 11/15 (73.3%) | ||
| Cardiac disorders | ||||
| Rehospitalization | 7/12 (58.3%) | 15 | 7/15 (46.7%) | 11 |
| Gastrointestinal disorders | ||||
| Rehospitalization | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| General disorders | ||||
| Rehospitalization | 1/12 (8.3%) | 1 | 2/15 (13.3%) | 2 |
| Infections and infestations | ||||
| Rehospitalization | 1/12 (8.3%) | 1 | 0/15 (0%) | 0 |
| Nervous system disorders | ||||
| Rehospitalization | 0/12 (0%) | 0 | 1/15 (6.7%) | 1 |
| Renal and urinary disorders | ||||
| Rehospitalization | 0/12 (0%) | 0 | 1/15 (6.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Rehospitalization | 1/12 (8.3%) | 1 | 3/15 (20%) | 3 |
| Surgical and medical procedures | ||||
| Rehospitalization | 0/12 (0%) | 0 | 1/15 (6.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| No Intervention | Active Comparator | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/12 (16.7%) | 5/15 (33.3%) | ||
| General disorders | ||||
| ED visit | 2/12 (16.7%) | 2 | 2/15 (13.3%) | 3 |
| Injury, poisoning and procedural complications | ||||
| ED visit | 0/12 (0%) | 0 | 1/15 (6.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Urgent Care Visit | 0/12 (0%) | 0 | 1/15 (6.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| ED visit | 0/12 (0%) | 0 | 1/15 (6.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Dalane Kitzman |
|---|---|
| Organization | Wake Forest School of Medicine |
| Phone | 336-716-2227 |
| dkitzman@wakehealth.edu |
- IRB00016973