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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG045551 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a multicenter, randomized, attention-controlled, single-blind trial designed to examine the hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will improve physical function and key clinical outcomes, including the rate of rehospitalization.
There will be three lead centers, Wake Forest Baptist Health along with Thomas Jefferson University and Hospital-Co-Investigator Dr. David Whellan, and Duke University Medical Center-Co-Investigator Dr. Christopher O'Connor. Each center may recruit up to 3 geographically close, tightly affiliated 'satellite' sites under their management and budgetary control. Together, these sites will recruit a total of 352 consenting patients ≥ 60 years old hospitalized with ADHF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 12-week novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The multi-domain rehabilitation intervention will include endurance, mobility, strength, and balance training and will be tailored based on participant performance in each of these domains. It will begin upon randomization during the hospitalization and will continue 3 times per week in an outpatient setting. Participants randomized to the attention control arm will receive all services ordered by their primary physician and will be contacted bi-weekly by study staff. All participants will undergo measures of physical function and quality of life at baseline, 1 month, and 3 months. Clinical events will be monitored for 6 months following the index hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | Other | Usual care group with bi-weekly contact from study staff |
|
| multi-domain rehabilitation intervention | Active Comparator | Individual, tailored, progressive, physical function rehabilitation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-domain rehabilitation intervention | Behavioral | Individual, tailored, progressive physical function rehabilitation intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery (SPPB) at Month 3 | The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Rehospitalization | Number of all-cause rehospitalizations 6 months from index hospital discharge. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute Walk Distance | Exploratory outcome. Distance walked in 6 minutes. | Month 3 |
| Handgrip Strength | Exploratory outcome. Handgrip strength is measured in kilograms by a handgrip dynamometer. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalane W. Kitzman, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Wake Forest Baptist Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41500239 | Derived | Damluji AA, Bruce SA, Reeves G, Pastva AM, Bertoni AG, Mentz RJ, Whellan DJ, Kitzman DW, deFilippi CR. Circulating Biomarkers as Predictors of Improvement in Physical Function in Hospitalized Older Adults With Geriatric Syndromes: Findings From the REHAB-HF Trial. Circ Heart Fail. 2026 Jan 7:e013251. doi: 10.1161/CIRCHEARTFAILURE.125.013251. Online ahead of print. | |
| 39291487 | Derived | Corsi DR, Dikdan S, Upadhyay N, Chen H, Kitzman DW, Mentz R, Whellan DJ, Frisch DR. Atrial Fibrillation Status and Physical Rehabilitation in Older Patients With Acute Decompensated Heart Failure: An Analysis From the REHAB-HF Trial. J Am Heart Assoc. 2024 Oct;13(19):e034366. doi: 10.1161/JAHA.124.034366. Epub 2024 Sep 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control | Usual care group with bi-weekly contact |
| FG001 | Rehabilitation Intervention | Individual, tailored, progressive, multi-domain physical function rehabilitation intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | Usual care group with bi-weekly contact |
| BG001 | Rehabilitation Intervention | Individual, tailored, progressive, multi-domain physical function 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 | Short Physical Performance Battery (SPPB) at Month 3 | The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function. | Analysis completed on all participants alive with Month 3 SPPB obtained (n=304). | Posted | Least Squares Mean | Standard Error | score on a scale | Month 3 |
|
AEs collected from date of discharge from index hospitalization through Month 6.
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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 | Attention Control | Usual care group with bi-weekly contact | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dalane Kitzman | Wake Forest School of Medicine | 336-716-3274 | dkitzman@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2018 | May 20, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2019 | May 28, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Attention Control | Behavioral | Usual care with bi-weekly contact from study staff |
|
| Month 3 |
| Frailty Status (Fried Frailty Criteria) at Month 3 | Exploratory outcome. Frailty is assessed by the Fried criteria consisting of 5 components: low physical activity, exhaustion, weakness, slowness, and unintentional weight loss. Presence of 3 or more Fried criteria indicates frailty, 1-2 criteria indicates pre-frailty, and 0 criteria indicates no frailty. | Month 3 |
| Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Exploratory outcome. The KCCQ Overall Summary Summary Score is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status. | Month 3 |
| Physical Limitation as Assessed by the KCCQ Physical Limitation Score | Exploratory outcome. The Physical Limitation Score of the KCCQ questionnaire is a subscore evaluating disease-specific physical limitation. Scores range 0-100 with a higher score indicating less physical limitation. | Month 3 |
| Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12) | Exploratory outcome. The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status. | Month 3 |
| Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L) | Exploratory outcome. The EQ-5D-5L is a quality of life tool with 5 components designed to detect health utilities: mobility, usual activities, self-care, pain/discomfort, and anxiety/depression. All components are rated on a scale of 1-5 with higher scores indicating worse health status. | Month 6 |
| Depression Measured by the Geriatric Depression Scale | Exploratory outcome. The Geriatric Depression Scale is a 15-item questionnaire evaluating depressive symptoms. Scores range from 0-15 with a higher score indicating more severe depressive symptoms. | Month 3 |
| Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA) | Exploratory outcome. The Montreal Cognitive Assessment is a tool for assessing multiple domains of cognitive function. Scores range 0-30 with higher scores indicating better cognitive function. A score greater than or equal to 26 is considered normal cognitive function. | Month 3 |
| All-cause Rehospitalizations at Month 1 | Exploratory outcome. Number of all-cause rehospitalizations 1 month post index hospitalization discharge. | Month 1 |
| All-cause Rehospitalizations at Month 3 | Exploratory outcome. Number of all-cause rehospitalizations 3 months after discharged from index hospitalization | Month 3 |
| All-cause Combined Rehospitalization and Death at Month 6 | Exploratory outcome. Combined number of all-cause rehospitalizations and death 6 months after discharge from index hospitalization | Month 6 |
| Heart Failure Rehospitalizations at Month 6 | Exploratory outcome. Number of heart failure rehospitalizations 6 months after discharge from index hospitalization | Month 6 |
| Hospitalization Days Post-randomization | Exploratory outcome. Total days spent hospitalized after date of randomization. | Month 6 |
| Facility-free Days Alive | Exploratory outcomes. Total days alive spent outside of hospital, observation unit, acute rehab setting, and skilled nursing facility 6 months after discharge from index hospitalization. | Month 6 |
| Emergency Department Visits | Exploratory outcomes. Number of emergency department visits after 6 months from hospital discharge | Month 6 |
| Observation Unit Stays <24 Hours | Exploratory outcome. Number of observation unit stays <24 hours 6 months after discharge from index hospitalization | Month 6 |
| Unscheduled Urgent Medical Visits | Exploratory outcome. Number of unscheduled urgent medical visits after discharge from index hospitalization | Month 6 |
| Global Rank Score of Short Physical Performance Battery Score + All-cause Rehospitalization + Death | Exploratory outcome. The global rank composite outcome combines non-commensurate endpoints including death, number of all-cause rehospitalizations, and month 3 SPPB into a single non-parametric outcome in a hierarchical manner with death being ranked first and SPPB being ranked last. Participants are ranked from the most adverse response (lowest rank) to the most favorable response (highest rank). | Month 6 |
| Placement at Skilled Nursing Facility | Exploratory outcome. Number of placements at skilled nursing facilities after discharge from index hospitalization. | Month 6 |
| Physical Activity Assessed by Accelerometry | Exploratory outcome. Physical activity assessed by accelerometry quantified in moderate-vigorous physical activity minutes per day. | Month 6 |
| Generalized Optimism Assessed by the Life Orientation Test-Revised | Exploratory outcome. The Life Orientation Test-Revised is a assessment of generalized optimism scored on a scale of 0-24 with higher scores indicating higher optimism. | Month 3 |
| Economic Analysis | Assess direct medical costs, direct non-medical costs, indirect patient time costs, short-term cost-analysis, long-term cost analysis, and sustainability of the intervention. | Month 6 |
| Biomarkers | Two well-accepted biomarkers of HF disease severity and prognosis, NT-proBNP and galectin-3, and increased biomarkers in older HF patients Tumor necrosis factor alpha, C-reactive protein, and interleukin-6. | Month 3 |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
| Thomas Jefferson University and Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| 37889196 | Derived | Gilbert ON, Mentz RJ, Bertoni AG, Kitzman DW, Whellan DJ, Reeves GR, Duncan PW, Nelson MB, Blumer V, Chen H, Reed SD, Upadhya B, O'Connor CM, Pastva AM. Relationship of Race With Functional and Clinical Outcomes With the REHAB-HF Multidomain Physical Rehabilitation Intervention for Older Patients With Acute Heart Failure. J Am Heart Assoc. 2023 Nov 7;12(21):e030588. doi: 10.1161/JAHA.123.030588. Epub 2023 Oct 27. |
| 36598761 | Derived | Pandey A, Kitzman DW, Nelson MB, Pastva AM, Duncan P, Whellan DJ, Mentz RJ, Chen H, Upadhya B, Reeves GR. Frailty and Effects of a Multidomain Physical Rehabilitation Intervention Among Older Patients Hospitalized for Acute Heart Failure: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2023 Feb 1;8(2):167-176. doi: 10.1001/jamacardio.2022.4903. |
| 36372251 | Derived | Nelson MB, Shiroma EJ, Kitzman DW, Duncan PW, Reeves GR, Whellan DJ, Mentz RJ, Chen H, Pastva AM. Physical activity and relationship to physical function, quality of life, and cognitive function in older patients with acute decompensated heart failure. Am Heart J. 2023 Feb;256:85-94. doi: 10.1016/j.ahj.2022.11.002. Epub 2022 Nov 11. |
| 36345825 | Derived | Whellan D, McCarey MM, Chen H, Nelson MB, Pastva AM, Duncan P, Mentz RJ, Kitzman DW, Reeves G, Reed SD. Quality of Life Trajectory and Its Mediators in Older Patients With Acute Decompensated Heart Failure Receiving a Multi-Domain Rehabilitation Intervention: Results From the Rehabilitation Therapy in Older Acute Heart Failure Patients Trial. Circ Heart Fail. 2022 Dec;15(12):e009695. doi: 10.1161/CIRCHEARTFAILURE.122.009695. Epub 2022 Nov 8. |
| 36164731 | Derived | Peters AE, Kitzman DW, Chen H, Nelson MB, Pastva AM, Duncan PW, Reeves GR, Upadhya B, Whellan DJ, Mentz RJ. Obesity Status and Physical Rehabilitation in Older Patients Hospitalized With Acute HF: Insights From REHAB-HF. JACC Heart Fail. 2022 Dec;10(12):918-927. doi: 10.1016/j.jchf.2022.07.008. Epub 2022 Sep 7. |
| 35656973 | Derived | Nelson MB, Gilbert ON, Duncan PW, Kitzman DW, Reeves GR, Whellan DJ, Mentz RJ, Chen H, Hewston LA, Taylor KM, Pastva AM. Intervention Adherence in REHAB-HF: Predictors and Relationship With Physical Function, Quality of Life, and Clinical Events. J Am Heart Assoc. 2022 Jun 7;11(11):e024246. doi: 10.1161/JAHA.121.024246. Epub 2022 Jun 3. |
| 34246602 | Derived | Mentz RJ, Whellan DJ, Reeves GR, Pastva AM, Duncan P, Upadhya B, Nelson MB, Chen H, Reed SD, Rosenberg PB, Bertoni AG, O'Connor CM, Kitzman DW. Rehabilitation Intervention in Older Patients With Acute Heart Failure With Preserved Versus Reduced Ejection Fraction. JACC Heart Fail. 2021 Oct;9(10):747-757. doi: 10.1016/j.jchf.2021.05.007. Epub 2021 Jul 7. |
| 33999544 | Derived | Kitzman DW, Whellan DJ, Duncan P, Pastva AM, Mentz RJ, Reeves GR, Nelson MB, Chen H, Upadhya B, Reed SD, Espeland MA, Hewston L, O'Connor CM. Physical Rehabilitation for Older Patients Hospitalized for Heart Failure. N Engl J Med. 2021 Jul 15;385(3):203-216. doi: 10.1056/NEJMoa2026141. Epub 2021 May 16. |
| 30571197 | Derived | Warraich HJ, Kitzman DW, Whellan DJ, Duncan PW, Mentz RJ, Pastva AM, Nelson MB, Upadhya B, Reeves GR. Physical Function, Frailty, Cognition, Depression, and Quality of Life in Hospitalized Adults >/=60 Years With Acute Decompensated Heart Failure With Preserved Versus Reduced Ejection Fraction. Circ Heart Fail. 2018 Nov;11(11):e005254. doi: 10.1161/CIRCHEARTFAILURE.118.005254. |
| 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. |
| Lost to Follow-up |
|
| 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 |
|
| Short Physical Performance Battery | The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function. | Mean | Standard Deviation | Score on a Scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | All-Cause Rehospitalization | Number of all-cause rehospitalizations 6 months from index hospital discharge. | All participants, regardless of participation in the intervention or Month 3 follow-up were followed for all-cause rehospitalizations. Analysis completed on all participants, including deaths, except participants lost to follow-up (n=1) and participants withdrawn from study (n=1). | Posted | Number | rehospitalizations | Month 6 |
|
|
|
|
| Other Pre-specified | 6-minute Walk Distance | Exploratory outcome. Distance walked in 6 minutes. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Handgrip Strength | Exploratory outcome. Handgrip strength is measured in kilograms by a handgrip dynamometer. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Frailty Status (Fried Frailty Criteria) at Month 3 | Exploratory outcome. Frailty is assessed by the Fried criteria consisting of 5 components: low physical activity, exhaustion, weakness, slowness, and unintentional weight loss. Presence of 3 or more Fried criteria indicates frailty, 1-2 criteria indicates pre-frailty, and 0 criteria indicates no frailty. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Exploratory outcome. The KCCQ Overall Summary Summary Score is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Physical Limitation as Assessed by the KCCQ Physical Limitation Score | Exploratory outcome. The Physical Limitation Score of the KCCQ questionnaire is a subscore evaluating disease-specific physical limitation. Scores range 0-100 with a higher score indicating less physical limitation. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12) | Exploratory outcome. The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Quality of Life Assessed by the EuroQol 5-dimension 5-level (EQ-5D-5L) | Exploratory outcome. The EQ-5D-5L is a quality of life tool with 5 components designed to detect health utilities: mobility, usual activities, self-care, pain/discomfort, and anxiety/depression. All components are rated on a scale of 1-5 with higher scores indicating worse health status. | Not Posted | Month 6 | Participants |
| Other Pre-specified | Depression Measured by the Geriatric Depression Scale | Exploratory outcome. The Geriatric Depression Scale is a 15-item questionnaire evaluating depressive symptoms. Scores range from 0-15 with a higher score indicating more severe depressive symptoms. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA) | Exploratory outcome. The Montreal Cognitive Assessment is a tool for assessing multiple domains of cognitive function. Scores range 0-30 with higher scores indicating better cognitive function. A score greater than or equal to 26 is considered normal cognitive function. | Not Posted | Month 3 | Participants |
| Other Pre-specified | All-cause Rehospitalizations at Month 1 | Exploratory outcome. Number of all-cause rehospitalizations 1 month post index hospitalization discharge. | Not Posted | Month 1 | Participants |
| Other Pre-specified | All-cause Rehospitalizations at Month 3 | Exploratory outcome. Number of all-cause rehospitalizations 3 months after discharged from index hospitalization | Not Posted | Month 3 | Participants |
| Other Pre-specified | All-cause Combined Rehospitalization and Death at Month 6 | Exploratory outcome. Combined number of all-cause rehospitalizations and death 6 months after discharge from index hospitalization | Not Posted | Month 6 | Participants |
| Other Pre-specified | Heart Failure Rehospitalizations at Month 6 | Exploratory outcome. Number of heart failure rehospitalizations 6 months after discharge from index hospitalization | Not Posted | Month 6 | Participants |
| Other Pre-specified | Hospitalization Days Post-randomization | Exploratory outcome. Total days spent hospitalized after date of randomization. | Not Posted | Month 6 | Participants |
| Other Pre-specified | Facility-free Days Alive | Exploratory outcomes. Total days alive spent outside of hospital, observation unit, acute rehab setting, and skilled nursing facility 6 months after discharge from index hospitalization. | Not Posted | Month 6 | Participants |
| Other Pre-specified | Emergency Department Visits | Exploratory outcomes. Number of emergency department visits after 6 months from hospital discharge | Not Posted | Month 6 | Participants |
| Other Pre-specified | Observation Unit Stays <24 Hours | Exploratory outcome. Number of observation unit stays <24 hours 6 months after discharge from index hospitalization | Not Posted | Month 6 | Participants |
| Other Pre-specified | Unscheduled Urgent Medical Visits | Exploratory outcome. Number of unscheduled urgent medical visits after discharge from index hospitalization | Not Posted | Month 6 | Participants |
| Other Pre-specified | Global Rank Score of Short Physical Performance Battery Score + All-cause Rehospitalization + Death | Exploratory outcome. The global rank composite outcome combines non-commensurate endpoints including death, number of all-cause rehospitalizations, and month 3 SPPB into a single non-parametric outcome in a hierarchical manner with death being ranked first and SPPB being ranked last. Participants are ranked from the most adverse response (lowest rank) to the most favorable response (highest rank). | Not Posted | Month 6 | Participants |
| Other Pre-specified | Placement at Skilled Nursing Facility | Exploratory outcome. Number of placements at skilled nursing facilities after discharge from index hospitalization. | Not Posted | Month 6 | Participants |
| Other Pre-specified | Physical Activity Assessed by Accelerometry | Exploratory outcome. Physical activity assessed by accelerometry quantified in moderate-vigorous physical activity minutes per day. | Not Posted | Month 6 | Participants |
| Other Pre-specified | Generalized Optimism Assessed by the Life Orientation Test-Revised | Exploratory outcome. The Life Orientation Test-Revised is a assessment of generalized optimism scored on a scale of 0-24 with higher scores indicating higher optimism. | Not Posted | Month 3 | Participants |
| Other Pre-specified | Economic Analysis | Assess direct medical costs, direct non-medical costs, indirect patient time costs, short-term cost-analysis, long-term cost analysis, and sustainability of the intervention. | Not Posted | Month 6 | Participants |
| Other Pre-specified | Biomarkers | Two well-accepted biomarkers of HF disease severity and prognosis, NT-proBNP and galectin-3, and increased biomarkers in older HF patients Tumor necrosis factor alpha, C-reactive protein, and interleukin-6. | Not Posted | Month 3 | Participants |
| 174 |
| 115 |
| 174 |
| 69 |
| 174 |
| EG001 | Rehabilitation Intervention | Individual, tailored, progressive, multi-domain physical function rehabilitation intervention | 21 | 175 | 106 | 175 | 60 | 175 |
| epitaxis | Blood and lymphatic system disorders | Systematic Assessment |
|
| leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| aortic valve disease | Cardiac disorders | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| atrial flutter | Cardiac disorders | Systematic Assessment |
|
| bradycardia | Cardiac disorders | Systematic Assessment |
|
| cardiac arrest | Cardiac disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| heart failure exacerbation | Cardiac disorders | Systematic Assessment |
|
| mitral stenosis | Cardiac disorders | Systematic Assessment |
|
| mitral valve repair | Cardiac disorders | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| sudden cardiac death | Cardiac disorders | Systematic Assessment |
|
| supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| ventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| colitis | Gastrointestinal disorders | Systematic Assessment |
|
| colonic fistula | Gastrointestinal disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
|
| gastroparesis | Gastrointestinal disorders | Systematic Assessment |
|
| inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
| multiple organ failure | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| edema | General disorders | Systematic Assessment |
|
| non-cardiac chest pain | General disorders | Systematic Assessment |
|
| cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
|
| hepatotoxicity | Hepatobiliary disorders | Systematic Assessment |
|
| liver cirrhosis | Hepatobiliary disorders | Systematic Assessment |
|
| primary amyloidosis | Immune system disorders | Systematic Assessment |
|
| bacterial endocarditis | Infections and infestations | Systematic Assessment |
|
| influenza | Infections and infestations | Systematic Assessment |
|
| osteomyelitis | Infections and infestations | Systematic Assessment |
|
| sepsis | Infections and infestations | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | Systematic Assessment |
|
| wound infection | Infections and infestations | Systematic Assessment |
|
| fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| injurious fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| intracranial hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| oxycontin overdose | Injury, poisoning and procedural complications | Systematic Assessment |
|
| serotonin syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
|
| spinal compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| tacrolimus toxicity | Injury, poisoning and procedural complications | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| gout flare | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| chronic lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| metastatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| pancreatic adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| dysarthia | Nervous system disorders | Systematic Assessment |
|
| neuropathy | Nervous system disorders | Systematic Assessment |
|
| stroke | Nervous system disorders | Systematic Assessment |
|
| syncope | Nervous system disorders | Systematic Assessment |
|
| transient ischemic attack | Nervous system disorders | Systematic Assessment |
|
| sucidal ideation | Psychiatric disorders | Systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | Systematic Assessment |
|
| vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| diabetic foot ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| ablation | Surgical and medical procedures | Systematic Assessment |
|
| arteriovenous fistula placement | Surgical and medical procedures | Systematic Assessment |
|
| bronchoscopy | Surgical and medical procedures | Systematic Assessment |
|
| cateract surgery | Surgical and medical procedures | Systematic Assessment |
|
| implantable cardioverter defibrillator implantation | Surgical and medical procedures | Systematic Assessment |
|
| pacemaker implantation | Surgical and medical procedures | Systematic Assessment |
|
| remodulin pump implantation | Surgical and medical procedures | Systematic Assessment |
|
| renal artery angioplasty | Surgical and medical procedures | Systematic Assessment |
|
| hematoma | Vascular disorders | Systematic Assessment |
|
| hypertension | Vascular disorders | Systematic Assessment |
|
| hypotension | Vascular disorders | Systematic Assessment |
|
| pulmonary embolism | Vascular disorders | Systematic Assessment |
|
| elevated international normalized ratio | Blood and lymphatic system disorders | Systematic Assessment |
|
| epitaxis | Blood and lymphatic system disorders | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| bradycardia | Cardiac disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| heart failure exacerbation | Cardiac disorders | Systematic Assessment |
|
| suprventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| sudden vision loss | Eye disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
|
| melena | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| edema | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| non-cardiac chest pain | General disorders | Systematic Assessment |
|
| weakness | General disorders | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | Systematic Assessment |
|
| abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| ear injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| fall (self-reported) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| foot wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| ICD device complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| inguinal hernia | Injury, poisoning and procedural complications | Systematic Assessment |
|
| post-prodecural complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| fluid retention | Metabolism and nutrition disorders | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| gout flare | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| muscle strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| altered mental status | Nervous system disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| neuropathy | Nervous system disorders | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| syncope | Nervous system disorders | Systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| elevated creatinine | Renal and urinary disorders | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | Systematic Assessment |
|
| kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| hypertension | Vascular disorders | Systematic Assessment |
|
| hypotension | Vascular disorders | Systematic Assessment |
|
| venous stasis | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided