The Early Strength Training Program in Post-transplant Liver Cases

Not Applicable

Completed

• Conditions: Sarcopenia; Muscle Loss; Muscle Weakness; Chronic Liver Failure; Liver Transplant Disorder; Fatigue; Quality of Life; End Stage Liver DIsease

• Registration Number: NCT04546048
• Lead Sponsor: Memorial Hospital Groups

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Primary Completion: 2019-08-24
• Study Completion: 2019-08-24
• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-06
• Study First Posted: 2020-09-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strength	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Fatigue	baseline (pre-operative), 4th and 8th post-operative week	The 20-item patient-assessed questionnaire Turkish version of Checklist Individual Strength (CIS-T) was used to assess four qualitatively different and relevant aspects of fatigue. Each item is scored on a 7-point Likert scale.
Health-related Quality of Life	baseline (pre-operative), 4th and 8th post-operative week	HRQoL was measured by Short-Form 36 as a generic tool and The Liver Disease Symptom Index 2.0 as a disease-specific 24-item assessment tool to evaluate the effect of symptoms and their severity on daily activities of patients with chronic liver disease.

Trial Locations

Locations (1)

Memorial Hospital Groups; 🇹🇷 Istanbul, Turkey