Pulmonary Rehabilitation in End-Stage Liver Disease

Overview

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

Full Title of Study: “Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2019

Detailed Description

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.

Interventions

  • Behavioral: Pulmonary Rehabilitation Exercise
    • 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
  • Behavioral: Home Based Exercise
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: Pulmonary Rehabilitation
    • Participants will participate in formal Pulmonary Rehabilitation Exercise program
  • Active Comparator: Home based program
    • Participants will participate in a Home based Exercise program

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kymberly D. Watt, MD – Mayo Clinic
  • Overall Official(s)
    • Kymberly D Watt, Principal Investigator, Mayo Clinic

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