Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis — STIMUCO  

Cystic Fibrosis Clinical Trial

Official title: Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction

Status Terminated

Clinical Trial Summary

This is an add-on, randomized, open label, clinical trial that evaluates the use of quadriceps electrostimulation as an additional retraining procedure in patients suffering from cystic fibrosis.

Clinical Trial Description

Cystic fibrosis is an autosomal recessive genetic disease due to a mutation of the CFTR protein gene. The CFTR protein transports chloride ions (Cl-) across cell membranes in the lungs, pancreas, digestive tract, reproductive tract, and skin.

CFTR mutation mainly leads to a dysfunction of the pulmonary system and pancreas exocrine function.

Several studies showed that cystic fibrosis commonly induces a reduction of effort tolerance, peripheral muscular strength and work capacity.

Patients suffering from cystic fibrosis with a high endurance capacity have a lower risk of poor prognosis. Those with a severe dyspnea have a higher benefit with a force training or a combined force and endurance training than with endurance training alone.

We propose to study the effect of a quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer, in patients with cystic fibrosis associated with severe pulmonary dysfunction, to enhance their muscular performance and increase their adherence to the cycloergometer retraining program.

This is a randomized trial with two groups:

Group A: experimental group, twenty patients. Six weeks with electrostimulation program followed by six weeks under a cycloergometer program.

Group B: control group, twenty patients. Six weeks with their usual physical activity followed by six weeks with a cycloergometer program.

The Randomization is stratified on expiratory volume per second. The size of randomization blocks is random because of the open design. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Mucoviscidosis

• NCT number: NCT00391703
• Study type: Interventional
• Source: University Hospital, Grenoble
• Status: Terminated
• Phase: N/A
• Start date: October 2006
• Completion date: September 2010