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