Pulmonary Rehabilitation in End-Stage Liver Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program

Detailed Description
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Participants will be randomized into two groups. The Pulmonary Rehabilitation group will undergo exercise under a supervised setting for a total duration of 12 weeks. Patients will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session. Exercises will be supervised by physiotherapists or exercise physiologists. Compliance and performance will be monitored by the trainer. They will receive a pedometer for home use. The Home based program group will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Patients will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.

Official Title
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Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?

Conditions
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End Stage Liver Disease

Intervention / Treatment
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* Behavioral: Pulmonary Rehabilitation Exercise
* Behavioral: Home Based Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: wait listed for liver transplantation with poor 6 MWT Exclusion Criteria: age < 18 years recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month large esophageal varices without primary prophylaxis active excessive alcohol intake (in the previous 3 months) current overt uncontrolled hepatic encephalopathy hepatopulmonary syndrome with uncontrolled hypoxia portopulmonary hypertension inability to perform exercise marked symptomatic comorbidities (cardiac, pulmonary, renal).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized to pulmonary rehab vs home based exercise rpogram
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary Rehabilitation<br>Participants will participate in formal Pulmonary Rehabilitation Exercise program | Behavioral: Pulmonary Rehabilitation Exercise<br>* Participants will undergo Pulmonary Rehabilitation exercise. Participants will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session<br>|
| Active Comparator: Home based program<br>Participants will participate in a Home based Exercise program | Behavioral: Home Based Exercise<br>* Participants will undergo Home based exercise program consisting of strength and conditioning. Participants will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Participants will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 minute walk test | Participants will walk on a straight, flat surface for 6 minutes at a self-determined pace. | baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Sarcopenia, Pulmonary Rehabilitation