NCT06269263

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

February 13, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients completing the program

    Percentage of patients completing the program

    After 12 weeks

Secondary Outcomes (2)

  • Quality of life by KCCQ

    After 12 weeks

  • Exercise capacity

    After 12 weeks

Study Arms (1)

Home-based cardiac rehabilitation

EXPERIMENTAL

Home-based cardiac rehabilitation

Behavioral: Home-based cardiac rehabilitation

Interventions

Guided by physiotherapists, patients will receive different trainings regrading endurance/balance/resistance,/coordination at home

Home-based cardiac rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic heart failure irrespective of the ejection fraction
  • Recent history of acute cardiac decompensation leading to hospitalization

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

  • Reuser A, Schittenhelm J, Schroder SC, Kandels J, Richter E, Gaal L, Pfister F, Stegmann T, Uhe T, Wachter R. Bridging the post-hospitalization gap: a feasibility study of home-based rehabilitation in decompensated heart failure. ESC Heart Fail. 2026 Feb 3;13(1):xvaf021. doi: 10.1093/eschf/xvaf021.

    PMID: 41711697BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pilot study of home-based cardiac rehabilitation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 21, 2024

Study Start

February 29, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication of main study results
Access Criteria
Upon reasonable request by other researchers

Locations