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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
40
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
Pneumology Department of Grenoble University Hospital
Grenoble, Isere, France
Pneumology Department of Lyon University Hospital
Lyon, Rhone, France
The six-minute walking distance
Time frame: 0, 1, 2 months
Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation
Time frame: 1 month
Inspiratory reserve volume (IRV), gasometry, dyspnea score
Time frame: 0, 1, 2 months
Measurement of voluntary maximum force and non cooperative force of the quadriceps
Time frame: 0, 1, 2 months
Area of quadriceps cross section measured with a scanner
Time frame: 1, 2 months
Quadriceps muscle mass
Time frame: 0, 1, 2 months
Quality of life: CFQ14, BDI-TDI questionnaires
Time frame: 0, 1, 2 months
Compliance with ergocycle rehabilitation
Time frame: 1 month
HOMA and QUICKI tests
Time frame: 0, 1, 2 months
Spirometry
Time frame: 0, 1, 2 months
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