Clinical trial NCT04546048: The Early Strength Training Program in Post-transplant Liver Cases
Official title: The Early Strength Training Exercise Therapy in Liver Recipients: Protocol for an Observational Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Liver DIsease
Chronic Liver Failure
Liver Transplant Disorder
Muscle Loss
Muscle Weakness
Sarcopenia
Fatigue
Quality of Life
Keywords: muscle strength
liver transplantation
resistance training
functional status
Lead sponsor: Memorial Hospital Groups
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory muscle strength
timeFrame: baseline (pre-operative), 4th and 8th post-operative week
measure: Peripheral muscle strength
timeFrame: baseline (pre-operative), 4th and 8th post-operative week
measure: Physical performance
timeFrame: baseline (pre-operative), 4th and 8th post-operative week
measure: Functional exercise capacity
timeFrame: baseline (pre-operative), 4th and 8th post-operative week
Secondary outcomes:
measure: Fatigue
timeFrame: baseline (pre-operative), 4th and 8th post-operative week
measure: Health-related Quality of Life
timeFrame: baseline (pre-operative), 4th and 8th post-operative week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Memorial Hospital Groups
Study officials:
References: