Cystic Fibrosis, Mucoviscidosis
Conditions
Keywords
Cystic fibrosis, mucoviscidosis, electrostimulation, retraining
Brief 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.
Detailed 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.
Interventions
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
Usual sport activity performed prior to an endurance retraining program using a cycloergometer
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The six-minute walking distance | 0, 1, 2 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation | 1 month |
| Compliance with ergocycle rehabilitation | 1 month |
| HOMA and QUICKI tests | 0, 1, 2 months |
| Spirometry | 0, 1, 2 months |
| Quality of life: CFQ14, BDI-TDI questionnaires | 0, 1, 2 months |
Countries
France