Pulmonary Rehabilitation in End-Stage Liver Disease

Mayo Clinic

Status: Terminated

Conditions: End Stage Liver Disease

Treatments: Behavioral: Pulmonary Rehabilitation Exercise; Behavioral: Home Based Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03266575

17-000852

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Pulmonary Rehabilitation

Active Comparator group

Description:

Participants will participate in formal Pulmonary Rehabilitation Exercise program

Treatment:

Behavioral: Pulmonary Rehabilitation Exercise

Home based program

Active Comparator group

Description:

Participants will participate in a Home based Exercise program

Treatment:

Behavioral: Home Based Exercise