Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis (STIMUCO)
|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|
|Cystic Fibrosis Mucoviscidosis||Behavioral: Electrostimulation programme: using a cycloergometer Behavioral: Usual sport activity|
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|
|Primary Completion Date :||November 2009|
|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 ]
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|