Effect of Physical Training Program on Health-related Quality of Life in Cirrhosis

NCT00517738 | Completed Phase 2

• 1 other identifier: CIIBH-Ref.1639/GAS 166-09/11-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The intention of this study is to assess if patients can improve their QOL and hepatic encephalopathy during a physical training program, and to address its safety.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Improvement in QOL questionnaires

  QOL will be measured by means of SF-36 and CLDQ

  3 months

• Lack of deterioration in portal hypertension

  This will be measured by the hepatic vein pressure gradient (HVPG) through liver catheterization

  3 months

Secondary Outcomes (4)

• Improvement in cognitive status

  3 months

• No increase in the rate of variceal bleeding and no progression in the number/size of esophageal varices

  3 months

• Improved ammonia metabolism and decrease in oxidative stress

  3 months

• Improvement in physical capacity and exercise tolerance

  3 months

Study Arms (4)

Physical training - No encephalopathy

EXPERIMENTAL

Patients randomized to the physical training program and diet intervention

Other: Physical training; Other: Diet intervention

Control - No encephalopathy

ACTIVE COMPARATOR

Patients not allocated to exercise program, but undergoing diet intervention

Other: Diet intervention

Physical training - Early encephalopathy

EXPERIMENTAL

Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program

Other: Physical training; Other: Diet intervention

Control - Early encephalopathy

ACTIVE COMPARATOR

Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention

Other: Diet intervention

Interventions

Physical training OTHER

A program of exercising under strict surveillance, with endurance and coordination maneuvers

Also known as: Exercise, Muscle ammonia metabolism

Physical training - Early encephalopathy; Physical training - No encephalopathy

Diet intervention OTHER

Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema

Also known as: Nutritional therapy, Diet

Control - Early encephalopathy; Control - No encephalopathy; Physical training - Early encephalopathy; Physical training - No encephalopathy

Eligibility Criteria

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

You may qualify if:

• Biopsy-proven or clinically evident cirrhosis
• Able to perform exercise

You may not qualify if:

• Overt hepatic encephalopathy grades 3 or 4
• Cardiovascular complications (pulmonary hypertension, heart failure)
• Diabetes mellitus and microangiopathic complications, or under treatment with insulin
• Renal failure
• Portal hypertension with high risk for variceal bleeding
• Hepatocellular carcinoma

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Instituto Nacional de Cardiologia Ignacio Chavez: collaborator

Study Sites (2)

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico City, 14000, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

Related Publications (1)

• Macias-Rodriguez RU, Ilarraza-Lomeli H, Ruiz-Margain A, Ponce-de-Leon-Rosales S, Vargas-Vorackova F, Garcia-Flores O, Torre A, Duarte-Rojo A. Changes in Hepatic Venous Pressure Gradient Induced by Physical Exercise in Cirrhosis: Results of a Pilot Randomized Open Clinical Trial. Clin Transl Gastroenterol. 2016 Jul 14;7(7):e180. doi: 10.1038/ctg.2016.38.

  PMID: 27415618 DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Physical Conditioning, Human; Exercise; Nutrition Therapy; Diet

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Sergio Ponce de Leon-Rosales, M.D.

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran / Universidad Nacional Autonoma de Mexico

  STUDY CHAIR

• Florencia Vargas-Voráckova, MD

  Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán/ Universidad Nacional Autónoma de México

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: February 1, 2007
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

ME (2)