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The Early Strength Training Program in Post-transplant Liver Cases

M

Memorial Hospital Groups

Status

Completed

Conditions

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

Treatments

Behavioral: Strength Exercise Training

Study type

Interventional

Funder types

Other

Identifiers

NCT04546048
2015970102

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Exercise group (EG)
Experimental group
Description:
The exercise group (EG) were received an 8-week resistance training program in addition to standard post-transplant physiotherapy follow-up.
Treatment:
Behavioral: Strength Exercise Training
Control Group (CG)
No Intervention group
Description:
The control group (CG) were received only standard physiotherapy program. The usual post-transplant care consisting of preoperative patient education, respiratory physiotherapy program, active/active assistive exercises of cervical, upper and lower extremities, and early mobilization. Patients were instructed about the postoperative physiotherapy process including all details within the preoperative education. Respiratory physiotherapy consisted of positioning, lung expansion exercises and bronchial hygiene techniques. They were allowed to pursue their normal daily activities and mobilized as early as possible when clinically stable.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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