Pulmonary Rehabilitation in End-Stage Liver Disease

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03266575

Collaborator

(none)

Enrollment

Location

Arms

58.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
End Stage Liver Disease	Behavioral: Pulmonary Rehabilitation Exercise Behavioral: Home Based Exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized to pulmonary rehab vs home based exercise rpogramrandomized to pulmonary rehab vs home based exercise rpogram

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pulmonary Rehabilitation Participants will participate in formal Pulmonary Rehabilitation Exercise program	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
Active Comparator: Home based program Participants will participate in a Home based Exercise program	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.

Arm

Intervention/Treatment

Active Comparator: Pulmonary Rehabilitation

Participants will participate in formal Pulmonary Rehabilitation Exercise program

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

Active Comparator: Home based program

Participants will participate in a Home based Exercise program

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Kymberly D Watt, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Kymberly D. Watt, MD, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03266575

Other Study ID Numbers:

17-000852

First Posted:

Aug 30, 2017

Last Update Posted:

Nov 15, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kymberly D. Watt, MD, Mayo Clinic

Frailty

Sarcopenia

Pulmonary Rehabilitation

Additional relevant MeSH terms:

Liver Diseases

End Stage Liver Disease

Study Results

No Results Posted as of Nov 15, 2021