The Early Strength Training Program in Post-transplant Liver Cases

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546048
• Other study ID #: 2015970102
• Status: Completed
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: August 24, 2019

Study information

• Verified date: November 2020
• Source: Memorial Hospital Groups
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 24, 2019
• Est. primary completion date: August 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Strength Exercise Training
The 8-week exercise-training program consisted of two 30-min sessions a day for 5 days/week and conducted by elastic exercise bands in 2-3 sets, 6-10 repetitions, with 1-2 min rest between sets (M. Deltoideus and M. Quadriceps are trained as major muscle groups). The 8-repetition maximum(8RM) is used to determine training loads with the rated perceived exertion(RPE) lower than 5-7 on the Modified Borg scale(MBS). The program consisted functional exercises by half squat to squat and sit-to-stand chair exercises. Exercise sessions were supervised twice daily during the 1st week, the 2nd week training included one supervised and one unsupervised daily sessions. The remaining 6-week training program conducted at home individually after discharge. Patients instructed for the ongoing 8-week training program and a patient-specific schedule delivered to subjects. Phone calls are provided weekly and training load is assessed while generating 4th week evaluations.

Locations

Country	Name	City	State
Turkey	Memorial Hospital Groups	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Hospital Groups

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle strength	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.	baseline (pre-operative), 4th and 8th post-operative week
Primary	Peripheral muscle strength	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.	baseline (pre-operative), 4th and 8th post-operative week
Primary	Physical performance	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.	baseline (pre-operative), 4th and 8th post-operative week
Primary	Functional exercise capacity	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.	baseline (pre-operative), 4th and 8th post-operative week
Secondary	Fatigue	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.	baseline (pre-operative), 4th and 8th post-operative week
Secondary	Health-related Quality of Life	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.	baseline (pre-operative), 4th and 8th post-operative week