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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
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Cystic Fibrosis Mucoviscidosis Behavioral: Electrostimulation programme: using a cycloergometer Behavioral: Usual sport activity

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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


Outcome Measures

Primary Outcome Measures :
  1. The six-minute walking distance [ Time Frame: 0, 1, 2 months ]

Secondary Outcome Measures :
  1. Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation [ Time Frame: 1 month ]
  2. Inspiratory reserve volume (IRV), gasometry, dyspnea score [ Time Frame: 0, 1, 2 months ]
  3. Measurement of voluntary maximum force and non cooperative force of the quadriceps [ Time Frame: 0, 1, 2 months ]
  4. Area of quadriceps cross section measured with a scanner [ Time Frame: 1, 2 months ]
  5. Quadriceps muscle mass [ Time Frame: 0, 1, 2 months ]
  6. Quality of life: CFQ14, BDI-TDI questionnaires [ Time Frame: 0, 1, 2 months ]
  7. Compliance with ergocycle rehabilitation [ Time Frame: 1 month ]
  8. HOMA and QUICKI tests [ Time Frame: 0, 1, 2 months ]
  9. Spirometry [ Time Frame: 0, 1, 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Patient suffering from cystic fibrosis
  • Patient has at least three measures of maximum expiratory volume per second <= 45% of the theory among the 6 last measures performed
  • Affiliation to French social security
  • Capacity to consent

Exclusion Criteria:

  • Pregnant women
  • Contraindication to application of magnetic field
  • Pacemaker
  • History of neurosurgical intervention
  • Presence of metallic particles near the stimulation site.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
France
Pneumology Department of Grenoble University Hospital
Grenoble, Isere, France, 38043
Pneumology Department of Lyon University Hospital
Lyon, Rhone, France, 69000
Sponsors and Collaborators
University Hospital, Grenoble
Vaincre la Mucoviscidose
Investigators
Study Director: Claire Cracowski, Dr Pneumology Department of Grenoble University Hospital
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. Eric Svahn, Clinical Research Department, Grenoble University Hospital
ClinicalTrials.gov Identifier: NCT00391703     History of Changes
Other Study ID Numbers: DCIC05/31
First Posted: October 24, 2006    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by University Hospital, Grenoble:
Cystic fibrosis
mucoviscidosis
electrostimulation
retraining

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases