NCT01508650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2012

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

February 7, 2019

Completed
Last Updated

February 7, 2019

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

December 21, 2011

Results QC Date

January 26, 2018

Last Update Submit

September 21, 2018

Conditions

Heart Failure

Keywords

heart failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • SPPB (Short Physical Performance Battery)

    up to 3 months

Study Arms (2)

No intervention

ACTIVE COMPARATOR

Usual care control group

Behavioral: Usual care

Active Comparator

ACTIVE COMPARATOR

Multi domain rehabilitation intervention

Behavioral: Rehabilitation intervention

Interventions

Usual careBEHAVIORAL

Usual care control group

No intervention
Rehabilitation interventionBEHAVIORAL

Multi-domain rehabilitation intervention

Active Comparator

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Planned discharge other than to home or a facility where the participant will live independently.
  • Acute myocardial infarction
  • Already participating in cardiac rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 28285121DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Dalane Kitzman
Organization
Wake Forest School of Medicine
dkitzman@wakehealth.edu
336-716-2227

Study Officials

  • Dalane W Kitzman, MD

    Wake Forest Baptist Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

January 12, 2012

Study Start

October 1, 2011

Primary Completion

June 8, 2012

Study Completion

September 7, 2012

Last Updated

February 7, 2019

Results First Posted

February 7, 2019

Record last verified: 2018-09

Locations

US(3)