Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-29 @ 8:11 AM
Study NCT ID:
NCT00391703
Status:
TERMINATED
Last Update Posted:
2010-11-11
First Post:
2006-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
enrolment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STIMUCO
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: