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

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Mucoviscidosis; Cystic Fibrosis

Treatments: Behavioral: Electrostimulation programme: using a cycloergometer; Behavioral: Usual sport activity

Study type: Interventional

Funder types: Other

Identifiers

NCT00391703

DCIC05/31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >= 18 years
• Patient suffering from cystic fibrosis
• Patient has at least three measures of maximum expiratory volume per second <= 45% of the theory among the 6 last measures performed
• Affiliation to French social security
• Capacity to consent

Exclusion criteria

• Pregnant women
• Contraindication to application of magnetic field
• Pacemaker
• History of neurosurgical intervention
• Presence of metallic particles near the stimulation site.

Trial design

40 participants in 2 patient groups

1

Experimental group

Description:

Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer

Treatment:

Behavioral: Electrostimulation programme: using a cycloergometer

2

Active Comparator group

Description:

Usual sport activity, performed prior to an endurance retraining program using a cycloergometer

Treatment:

Behavioral: Usual sport activity