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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cystic Fibrosis, Mucoviscidosis

Intervention / Treatment
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* Behavioral: Electrostimulation programme: using a cycloergometer
* Behavioral: Usual sport activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer | Behavioral: Electrostimulation programme: using a cycloergometer<br>* Quadriceps electrostimulation programme performed prior to an endurance retraining program using a cycloergometer, for 6 weeks, 60 to 90 minutes by session, 5 to 6 sessions per week<br>|
| Active Comparator: 2<br>Usual sport activity, performed prior to an endurance retraining program using a cycloergometer | Behavioral: Usual sport activity<br>* Usual sport activity performed prior to an endurance retraining program using a cycloergometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The six-minute walking distance |  | 0, 1, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation |  | 1 month | 
| Inspiratory reserve volume (IRV), gasometry, dyspnea score |  | 0, 1, 2 months | 
| Measurement of voluntary maximum force and non cooperative force of the quadriceps |  | 0, 1, 2 months | 
| Area of quadriceps cross section measured with a scanner |  | 1, 2 months | 
| Quadriceps muscle mass |  | 0, 1, 2 months | 
| Quality of life: CFQ14, BDI-TDI questionnaires |  | 0, 1, 2 months | 
| Compliance with ergocycle rehabilitation |  | 1 month | 
| HOMA and QUICKI tests |  | 0, 1, 2 months | 
| Spirometry |  | 0, 1, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic fibrosis, mucoviscidosis, electrostimulation, retraining