- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417423
Home-Based Exercise Education in Liver Transplant Recipients (Liv (Liver))
The Effect of Brochure- and Video-Based Home Exercise Education on Physical Activity, Fatigue, and Caregiver Burden in Liver Transplant Recipients: A Randomized Controlled Trial
Liver transplant recipients often experience reduced physical activity levels, fatigue, and increased caregiver burden after transplantation. Structured home-based exercise education may help improve these outcomes. This study aims to evaluate the effects of brochure-based and video-based home exercise education programs on physical activity levels, fatigue, and caregiver burden in liver transplant recipients.
Participants are assigned to either a brochure-based exercise education group, a video-based exercise education group, or a control group receiving standard care. The primary objective is to determine whether structured home exercise education improves physical activity and reduces fatigue and caregiver burden compared to standard care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Regular physical activity is essential for improving functional capacity and quality of life in liver transplant recipients. However, many recipients experience persistent fatigue, decreased physical activity levels, and increased caregiver burden after transplantation. Structured and accessible home-based exercise education may provide a practical approach to support long-term rehabilitation in this population.
This study evaluates the effectiveness of two different home-based exercise education methods: brochure-based education and video-based education. Participants receive standardized exercise recommendations designed to promote safe and gradual increases in physical activity. The intervention period includes structured follow-up and guidance to enhance adherence. A control group receives standard post-transplant care without structured exercise education.
Outcome measures include physical activity level, fatigue severity, and caregiver burden, assessed at predefined time points during the study period. The findings of this study may contribute to the development of accessible rehabilitation strategies for liver transplant recipients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gaziantep
-
Malatya, Gaziantep, Turkey (Türkiye), 27010
- Inonu University Turgut Ozal Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult liver transplant recipients
- Aged 18 years or older
- Clinically stable and cleared for participation in physical activity
- Able to understand and follow exercise instructions
- Provided written informed consent
Exclusion Criteria:
- Presence of severe cardiovascular, respiratory, or musculoskeletal conditions that contraindicate exercise
- Acute transplant rejection or severe post-transplant complications
- Cognitive impairment limiting participation
- Participation in another structured exercise program during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brochure-Based Exercise Education
Participants receive structured home-based exercise education delivered through a printed brochure.
The brochure includes information on safe physical activity, recommended exercises, frequency, intensity, and progression guidelines designed for liver transplant recipients.
|
Participants receive structured home-based exercise education delivered through a printed brochure specifically developed for liver transplant recipients.
The brochure includes written instructions and illustrations describing aerobic and strengthening exercises, along with recommendations for frequency, duration, intensity, and progression.
The material is designed to enable participants to independently perform safe and gradual physical activity at home throughout the study period.
|
|
Experimental: Video-Based Exercise Education
Participants receive structured home-based exercise education delivered through instructional videos.
The videos demonstrate recommended exercises, provide guidance on proper technique, frequency, intensity, and progression suitable for liver transplant recipients.
|
Home-Based Exercise Education consists of structured guidance designed to promote safe and progressive physical activity in liver transplant recipients.
The program includes recommendations regarding exercise type, frequency, duration, and intensity appropriate for the post-transplant period.
Education is delivered either through a printed brochure or instructional video materials.
The content focuses on aerobic and strengthening exercises that can be performed at home without specialized equipment.
Participants are encouraged to follow the prescribed exercise recommendations throughout the study period.
|
|
No Intervention: Standard Care Control
Participants receive standard post-transplant follow-up care without additional structured exercise education during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Level
Time Frame: Baseline and end of intervention (8 weeks)
|
International Physical Activity Questionnaire (IPAQ).
Physical activity is expressed as MET-minutes per week calculated from activity intensity and duration.
Scores range from 0 to >3000 MET-min/week, with higher values indicating higher physical activity level.
|
Baseline and end of intervention (8 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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