Pulmonary Rehabilitation in End-Stage Liver Disease
Primary Purpose
End Stage Liver Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulmonary Rehabilitation Exercise
Home Based Exercise
Sponsored by
About this trial
This is an interventional supportive care trial for End Stage Liver Disease focused on measuring Frailty, Sarcopenia, Pulmonary Rehabilitation
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).
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pulmonary Rehabilitation
Home based program
Arm Description
Participants will participate in formal Pulmonary Rehabilitation Exercise program
Participants will participate in a Home based Exercise program
Outcomes
Primary Outcome Measures
Change in 6 minute walk test
Participants will walk on a straight, flat surface for 6 minutes at a self-determined pace.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03266575
Brief Title
Pulmonary Rehabilitation in End-Stage Liver Disease
Official Title
Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease
Keywords
Frailty, Sarcopenia, Pulmonary Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized to pulmonary rehab vs home based exercise rpogram
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Rehabilitation
Arm Type
Active Comparator
Arm Description
Participants will participate in formal Pulmonary Rehabilitation Exercise program
Arm Title
Home based program
Arm Type
Active Comparator
Arm Description
Participants will participate in a Home based Exercise program
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation Exercise
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Home Based Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 6 minute walk test
Description
Participants will walk on a straight, flat surface for 6 minutes at a self-determined pace.
Time Frame
baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kymberly D Watt
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kymberly Watt, MD
Phone
507-266-1586
Email
watt.kymberly@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Pulmonary Rehabilitation in End-Stage Liver Disease
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