Pulmonary Rehabilitation in End-Stage Liver Disease

Not Applicable

Terminated

• Conditions: End Stage Liver Disease
• Interventions: Behavioral: Pulmonary Rehabilitation Exercise; Behavioral: Home Based Exercise

• Registration Number: NCT03266575
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-30
• Study Start: 2018-02-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-09
• Study Completion: 2024-12-09
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary Rehabilitation	Pulmonary Rehabilitation Exercise	Participants will participate in formal Pulmonary Rehabilitation Exercise program
Home based program	Home Based Exercise	Participants will participate in a Home based Exercise program

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States