Clinical Trials Logo
  1. Home
  2. End Stage Liver Disease
  3. NCT03266575
  4. Details
NCT03266575 Clinical Trial

Pulmonary Rehabilitation in End-Stage Liver Disease

End Stage Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03266575
Other study ID # 17-000852
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date December 2026

Study information
Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

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
• 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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03557086 - A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease N/A
Completed NCT04604860 - Use of EL-FIT App to Promote Physical Activity N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Recruiting NCT01728727 - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01724697 - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01728688 - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Not yet recruiting NCT01412593 - Intra-hepatic Artery Bone Marrow Derived Stem Cells Infusion for the Treatment of Advanced Liver Cirrhosis Phase 1/Phase 2
Completed NCT00374582 - End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA) N/A
Completed NCT00249652 - Transplant and Addiction Project (TAP) - 1 Phase 1/Phase 2
Recruiting NCT05998330 - LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease N/A
Completed NCT04546048 - The Early Strength Training Program in Post-transplant Liver Cases N/A
Active, not recruiting NCT03580629 - Pilot Study of the Liver Live Donor Champion Program N/A
Recruiting NCT04037995 - Real World Study of End-stage Liver Disease in China
Recruiting NCT03870568 - Functional Assessment in Liver Transplantation
Recruiting NCT03633812 - Effect of Preoperative Beta Blocker Use Postoperative Renal Function in the Patients Undergoing Liver Transplantation
Active, not recruiting NCT02889094 - French HIV-HBV Cohort
Completed NCT02444273 - The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital N/A
Recruiting NCT01711073 - Mobilization of Stem Cells With G-CSF and Mozobil in Patients With End Stage Liver Disease Phase 1
Not yet recruiting NCT06069050 - SALT in Adolescents With End-stage Liver Disease N/A
Recruiting NCT03228290 - Functional Assessment in Liver Transplantation

External Links