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

University of Alberta

Status: Completed

Conditions: Cirrhosis

Treatments: Behavioral: No Intervention; Behavioral: Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01960127

LZPTMH2.0

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups, including a placebo group

Aerobic Exercise

Experimental group

Description:

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

Treatment:

Behavioral: Aerobic Exercise

Usual Care Group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: No Intervention