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Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis (STIMUCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00391703
Recruitment Status : Terminated (enrolment difficulties)
First Posted : October 24, 2006
Last Update Posted : November 11, 2010
Sponsor:
Collaborator:
Vaincre la Mucoviscidose
Information provided by:
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE October 23, 2006
First Posted Date  ICMJE October 24, 2006
Last Update Posted Date November 11, 2010
Study Start Date  ICMJE October 2006
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
The six-minute walking distance [ Time Frame: 0, 1, 2 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2006)
The six-minute walking distance
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2006)
  • Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation
  • Inspiratory reserve volume (IRV), gasometry, dyspnea score
  • Measurement of voluntary maximum force and non cooperative force of the quadriceps
  • Area of quadriceps cross section measured with a scanner
  • Quadriceps muscle mass
  • Quality of life: CFQ14, BDI-TDI questionnaires
  • Compliance with ergocycle rehabilitation
  • HOMA and QUICKI tests
  • Spirometry
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
Official Title  ICMJE Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Cystic Fibrosis
  • Mucoviscidosis
Intervention  ICMJE
  • 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
  • Behavioral: Usual sport activity
    Usual sport activity performed prior to an endurance retraining program using a cycloergometer
Study Arms  ICMJE
  • Experimental: 1
    Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer
    Intervention: Behavioral: Electrostimulation programme: using a cycloergometer
  • Active Comparator: 2
    Usual sport activity, performed prior to an endurance retraining program using a cycloergometer
    Intervention: Behavioral: Usual sport activity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: October 23, 2006)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00391703
Other Study ID Numbers  ICMJE DCIC05/31
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M. Eric Svahn, Clinical Research Department, Grenoble University Hospital
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Vaincre la Mucoviscidose
Investigators  ICMJE
Study Director: Claire Cracowski, Dr Pneumology Department of Grenoble University Hospital
PRS Account University Hospital, Grenoble
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP