Pulmonary Rehabilitation in End-Stage Liver Disease

NCT03266575 | Terminated

• 1 other identifier: 17-000852
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Liver Disease

Keywords

Frailty; Sarcopenia; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pulmonary Rehabilitation

ACTIVE COMPARATOR

Participants will participate in formal Pulmonary Rehabilitation Exercise program

Behavioral: Pulmonary Rehabilitation Exercise

Home based program

ACTIVE COMPARATOR

Participants will participate in a Home based Exercise program

Behavioral: Home Based Exercise

Interventions

Pulmonary Rehabilitation Exercise 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

Pulmonary Rehabilitation

Home Based Exercise 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.

Home based program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• wait listed for liver transplantation with poor 6 MWT

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

End Stage Liver Disease; Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Kymberly D Watt

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized to pulmonary rehab vs home based exercise rpogram

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: August 30, 2017
• Study Start: February 1, 2018
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)