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临床试验/NCT04546048
NCT04546048已完成不适用

The Early Strength Training Exercise Therapy in Liver Recipients: Protocol for an Observational Feasibility Trial

Memorial Hospital Groups1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Respiratory muscle strength

研究概览

简要总结

Liver transplantation (LT) is a current life-saving procedure performed as an open-abdominal surgery for patients with end-stage liver diseases (ESLD). However, a high risk of post-surgical complications is relevant to major intra-abdominal interventions. In managing post-LT recovery, it is important to consider the extending pre-transplant physical status of ESLD patients concerning an impaired exercise capacity, a prolonged period of deconditioning, fatigue and muscle weakness, which leads to global motor impairment and decreased functional capacity.

Sarcopenia and physical deconditioning are known as the hallmark features of ESLD. The quality and the quantity of skeletal muscle mass have been closely correlated with post-transplantation mortality in individuals undergoing LT. In addition to chronic deconditioning or myopathy related to chronic liver failure, post-transplant immunosuppressive medication contributes to increased risk for age-related decline in muscular strength and physical ability. It reportedly persists impaired physical function including reduced muscle strength, which have been consistently associated with impaired quality of life after a liver transplant.

Exercise interventions in solid-organ recipients provide improvements in physical function including skeletal muscle strength. The literature has defined many types of exercise-based interventions including aerobic and resistive training or physical activity counselling in improving physical performance tasks, muscle strength and physical domain of quality of life in postoperative liver transplanted adults. Although there are studies in improving muscle performance and functional status, no study conducted in the post-transplant early period and an optimal exercise regimen for post-liver recipients. In the present study, it will be provided a framework for a possible change in practice aiming to improve muscle strength and functionality in liver recipients through a strength training exercise intervention at the early post-transplant period. The purposes of this trial were: 1) to evaluate the feasibility and safety of a strength exercise training program on functional mobility and quality of life of liver transplanted individuals and 2) to initiate physiotherapy protocols in this population. A key component of this approach was that it was individualized, providing one-to-one therapy with tailored progression specific to a person's individual mobility goals.

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

  • Liver recipients were eligible to participate if they were 1) over 18 years old, 2) completed the pre-operative evaluation procedure, 3) post-op hemodynamically stabled and had spontaneous breathing, 4) able to read, write and understand Turkish language.

排除标准

  • Study exclusion criteria were having unstable cardiovascular disease, a primary lung pathology requiring regular bronchodilator treatment, neuromusculoskeletal complication and/or limitation which requiring the use of assistive device, being a multi-organ transplant recipient and difficulty in following verbal orders.

结局指标

主要结局

Respiratory muscle strength

时间窗: baseline (pre-operative), 4th and 8th post-operative week

The measurement of the maximal inspiratory and expiratory pressures were measured during a maximal effort for 3 times. The highest value was recorded as cmH2O and also expressed as a percentage of predicted normal values.

Peripheral muscle strength

时间窗: baseline (pre-operative), 4th and 8th post-operative week

Knee extension, shoulder flexion and abduction were assessed with a handheld dynamometer. Three maximal isometric contractions are performed. The highest value during the preserved max tension for 1 s was recorded in kg.

Physical performance

时间窗: baseline (pre-operative), 4th and 8th post-operative week

30-s Sit-to-Stand Test (STST) provided the number of stands completed with the arms folded across the chest in 30 s. Each functional test was performed twice, in a standardized order, with a 5-min resting period and the best score was recorded.

Functional exercise capacity

时间窗: baseline (pre-operative), 4th and 8th post-operative week

Functional exercise capacity was determined by 6-minute walk test (6MWT). The distance covered in 6 minutes along a 30-meters corridor was recorded in meters (6MWD). The predicted 6MWD is calculated using the reference equations.

次要结局

  • Fatigue(baseline (pre-operative), 4th and 8th post-operative week)
  • Health-related Quality of Life(baseline (pre-operative), 4th and 8th post-operative week)

研究者

发起方
Memorial Hospital Groups
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tuba Ergene

MSc

Memorial Hospital Groups

研究点 (1)

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