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Clinical Trials/NCT03266575
NCT03266575
Terminated
Not Applicable

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

Mayo Clinic1 site in 1 country4 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End Stage Liver Disease
Sponsor
Mayo Clinic
Enrollment
4
Locations
1
Primary Endpoint
Change in 6 minute walk test
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
December 9, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kymberly D. Watt

MD

Mayo Clinic

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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.

Study Sites (1)

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