Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis (STIMUCO)
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|ClinicalTrials.gov Identifier: NCT00391703|
Recruitment Status : Terminated (enrolment difficulties)
First Posted : October 24, 2006
Last Update Posted : November 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Mucoviscidosis||Behavioral: Electrostimulation programme: using a cycloergometer Behavioral: Usual sport activity||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||September 2010|
Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer
Behavioral: Electrostimulation programme: using a cycloergometer
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
Active Comparator: 2
Usual sport activity, performed prior to an endurance retraining program using a cycloergometer
Behavioral: Usual sport activity
Usual sport activity performed prior to an endurance retraining program using a cycloergometer
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391703
|Pneumology Department of Grenoble University Hospital|
|Grenoble, Isere, France, 38043|
|Pneumology Department of Lyon University Hospital|
|Lyon, Rhone, France, 69000|
|Study Director:||Claire Cracowski, Dr||Pneumology Department of Grenoble University Hospital|