Effects of Aerobic Training on Exercise Capacity in Patients With Advanced Cirrhosis 2

NCT01960127 | Completed

• 1 other identifier: LZPTMH2.0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact on morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. The effect of this training has not yet been evaluated in the decompensated cirrhosis patient population. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change in peak exercise pulmonary oxygen uptake (peak V02)

  Baseline (day1) and Study End (8 weeks)

Secondary Outcomes (2)

• Change in muscle mass as measured by thigh ultrasound

  Baseline (day 1) and Study End (8 weeks)

• Change in quality of life-Chronic Liver Disease Questionnaire

  Baseline (day1) and Study End (8 weeks)

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions)

Behavioral: Aerobic Exercise

Usual Care Group

PLACEBO COMPARATOR

These patients will continue with their normal daily activity ad will not be provided with supervised aerobic exercise training during the study period.

Behavioral: No Intervention

Interventions

Aerobic Exercise BEHAVIORAL

Aerobic exercise

Aerobic Exercise

No Intervention BEHAVIORAL

No Intervention

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 and ≤ 70 years
• Cirrhosis
• Child Pugh class B or C
• If required, primary or secondary variceal prophylaxis in place

You may not qualify if:

• Post-liver transplantation
• Hepatocelluar carcinoma beyond transplant criteria
• Active non-hepatocelluar carcinoma malignancy
• Significant cardiac disease
• Hemoglobin (\<80 g/L)
• Oxygen saturation at rest \<95%
• Known myopathy
• Chronic renal failure on dialysis
• Physical impairment making it impossible to ride an exercise bike or treadmill
• Orthopedic abnormality preventing exercise training
• HIV infection
• Patient unwilling to consent to study

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta, Mazankowski Heart Institute

Edmonton, Alberta, T6G2B1, Canada

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Haykowsky, PhD

  University of Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: October 15, 2013
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

CA (1)