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临床试验/NCT07425314
NCT07425314已完成不适用

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

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年10月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
6-Minute Walk Test (6MWT) Distance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: 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.

结局指标

主要结局

6-Minute Walk Test (6MWT) Distance

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

İlker DEMİR

Principal Investigator

Inonu University

研究点 (1)

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