- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06269263
Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF) (Pilot-CRHF)
April 30, 2026 updated by: University of Leipzig
Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF)
The proposed study will determine the willingness of patients for participation.
Furthermore, the assessment of tests to identify eligible patients and the type of exercise intervention that goes along with a high patient compliance is crucial.
Also, more information about possible factors preventing patients from participating is required.
Therefore, if the patient is willing to participate, the investigators will assess patients' medical history, medication and QoL as well as parameters of routine diagnostics (i.e.
echocardiography, laboratory testing, MRI).
Following, while the in-patient stay due to cardiac decompensation, the investigators will conduct several assessment-tests to determine the physical status, the exercise capacity and the cognitive function.
Moreover, physiotherapists will instruct the patients in the exercise program.
After discharge from the hospital, physiotherapist will visit the patient at home to instruct them again in the exercises.
Then, the patients will conduct the program on their own for a period of 12 weeks.
During the exercise period, a doctoral student will visit the patients at home every 3 weeks to check whether they are doing the exercises correctly and to determine whether there are any problems with the program.
After the exercise period of 12 weeks, the baseline characteristics will be assessed again at the University Hospital Leipzig.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See above
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saxony
-
Leipzig, Saxony, Germany, 04103
- Universitätsklinikum Leipzig
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Chronic heart failure irrespective of the ejection fraction
- Recent history of acute cardiac decompensation leading to hospitalization
Exclusion Criteria:
- Patients not willing to participate
- Patients with orthopedic diseases limiting their mobility
- Cognitive diseases that hinder adequate participation in the opinion of the investigator
- Inpatient rehabilitation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home-based cardiac rehabilitation
|
Guided by physiotherapists, patients will receive different trainings regrading endurance/balance/resistance,/coordination at home
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients completing the program
Time Frame: After 12 weeks
|
Percentage of patients completing the program
|
After 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise capacity
Time Frame: After 12 weeks
|
Exercise capacity measured by 6-minutes walk test
|
After 12 weeks
|
|
Quality of life by KCCQ
Time Frame: After 12 weeks
|
QoL measured by Kansas City Cardiomyopathy Questionnaire (KCCQ).
KCCQ measures in values from 0 to 100 with higher values indicating better quality of life
|
After 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 29, 2024
Primary Completion (Actual)
April 30, 2025
Study Completion (Actual)
April 30, 2025
Study Registration Dates
First Submitted
February 13, 2024
First Submitted That Met QC Criteria
February 20, 2024
First Posted (Actual)
February 21, 2024
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
April 30, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 339/23-ek
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Not decided at this timepoint
IPD Sharing Time Frame
After publication of main study results
IPD Sharing Access Criteria
Upon reasonable request by other researchers
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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