Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF)

Heart Failure Clinical Trial

— Pilot-CRHF  

Official title:

Pilot Study to Determine Feasibility of Home-based Cardiac Rehabilitation in Patients With Chronic Heart Failure (Pilot-CRHF)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269263
• Other study ID #: 339/23-ek
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: University of Leipzig
• Contact: Annika Reuser, MD
• Phone: +49-341-97-12390
• Email: Annika.Reuser[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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, we 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, we 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.

Description:

See above

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1. Chronic heart failure irrespective of the ejection fraction 2. After acute cardiac decompensation leading to hospitalization

Exclusion Criteria:

• 1. Patients not willing to participate 2. Patients with orthopedic diseases limiting their mobility 3. Cognitive diseases that hinder adequate participation in the opinion of the investigator 4. Inpatient rehabilitation.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Home-based cardiac rehabilitation
Guided by physiotherapists, patients will receive different trainings regrading endurance/balance/resistance,/coordination at home

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients completing the program	Percentage of patients completing the program	After 12 weeks
Secondary	Quality of life	QoL measured by KCCQ	After 12 weeks
Secondary	Exercise capacity	Exercise capacity measured by 6-minutes walk test	After 12 weeks