Pulmonary Rehabilitation in End-Stage Liver Disease

NCT ID: NCT03266575

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2024-12-09

Brief Summary

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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

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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.

Conditions

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End Stage Liver Disease

Keywords

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Frailty Sarcopenia Pulmonary Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized to pulmonary rehab vs home based exercise rpogram
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pulmonary Rehabilitation

Participants will participate in formal Pulmonary Rehabilitation Exercise program

Group Type ACTIVE_COMPARATOR

Pulmonary Rehabilitation Exercise

Intervention Type BEHAVIORAL

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 program

Participants will participate in a Home based Exercise program

Group Type ACTIVE_COMPARATOR

Home Based Exercise

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kymberly D. Watt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kymberly D Watt

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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17-000852

Identifier Type: -

Identifier Source: org_study_id