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Clinical Trials/NCT07425314
NCT07425314
Completed
Not Applicable

Effects of The Telerehabilitation-Based Exercise Program On Muscle Strength, Exercise Capacity and Fatigue Levels in Liver Transplant Patients

Hasan Kalyoncu University1 site in 1 country140 target enrollmentStarted: October 12, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Hasan Kalyoncu University
Enrollment
140
Locations
1
Primary Endpoint
6-Minute Walk Test (6MWT) Distance

Overview

Brief Summary

This randomized controlled study aims to evaluate the effects of a telerehabilitation-based exercise program on muscle strength, exercise capacity, fatigue level, and cognitive status in adult liver transplant recipients. Liver transplantation is a major surgical procedure, and patients may experience reduced physical capacity, muscle weakness, and fatigue during recovery. Exercise-based rehabilitation may help improve these outcomes, but access to in-person rehabilitation programs may be limited after discharge.

Participants will be randomly assigned to either a control group receiving routine post-transplant care or an intervention group participating in a supervised telerehabilitation exercise program. The intervention consists of a 12-week program conducted twice weekly via video communication with a physiotherapist. Outcomes will be assessed at baseline and after completion of the program.

The study seeks to determine whether a structured, remotely supervised exercise program can improve functional recovery and reduce fatigue in liver transplant patients, potentially offering an accessible rehabilitation option after hospital discharge.

Detailed Description

Liver transplantation is a complex surgical procedure that requires a structured recovery process extending from the pre-transplant period through hospitalization and post-discharge phases. After transplantation, patients frequently experience reduced physical capacity, decreased muscle strength, fatigue, and functional limitations that may negatively affect quality of life and recovery. Early and structured rehabilitation interventions are therefore considered important components of post-transplant care.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult liver transplant recipients aged 18 years or older
  • Medically stable and cleared for participation in an exercise program
  • Able to communicate and cooperate with the researcher
  • Literate and able to understand instructions
  • No orthopedic or neurological condition that would limit exercise participation
  • Approximately one month post-discharge following liver transplantation
  • Willing to participate and provide informed consent

Exclusion Criteria

  • Presence of medical conditions that contraindicate exercise participation
  • Severe cardiovascular, respiratory, neurological, or musculoskeletal disorders that could interfere with the exercise program
  • Cognitive impairment preventing understanding of instructions or participation in assessments
  • Postoperative complications requiring activity restriction
  • Participation in another structured exercise or rehabilitation program during the study period
  • Refusal or inability to provide informed consent

Arms & Interventions

Telerehabilitation Exercise Group

Experimental

Participants assigned to this arm received a structured telerehabilitation-based exercise program in addition to routine post-transplant care. The program was conducted for 12 weeks, twice weekly, via real-time video communication with a physiotherapist. Sessions included warm-up exercises, posture and breathing exercises, isometric strengthening exercises, functional movements such as sit-to-stand, walking training, and cool-down stretching. Exercise intensity was maintained at a moderate level and progressed gradually throughout the program.

Intervention: Telerehabilitation Exercise Group (Behavioral)

Control Group

No Intervention

Participants assigned to this arm continued their routine daily activities and received standard post-transplant care without participating in a structured or supervised exercise or rehabilitation program during the study period.

Outcomes

Primary Outcomes

6-Minute Walk Test (6MWT) Distance

Time Frame: Baseline (pre-intervention) and end of the 12-week intervention period

Change in functional exercise capacity measured by the distance (meters) walked during the 6-minute walk test.

Fatigue Severity Scale

Time Frame: Baseline (pre-intervention) and end of the 12-week intervention period

Change in fatigue severity measured using the Fatigue Severity Scale (FSS). Total scores range from 9 to 63, with higher scores indicating greater fatigue severity.

Secondary Outcomes

  • Peripheral Oxygen Saturation (SpO₂)(Baseline and end of 12 weeks)
  • Montreal Cognitive Assessment (MoCA) Score(Baseline and end of 12 weeks)
  • Heart Rate(Baseline and end of 12 weeks)

Investigators

Sponsor
Hasan Kalyoncu University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

İlker DEMİR

Principal Investigator

Inonu University

Study Sites (1)

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