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NCT03266575 Clinical Trial

Pulmonary Rehabilitation in End-Stage Liver Disease

End Stage Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03266575
Other study ID # 17-000852
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date December 2026

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• 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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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