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

This study has been terminated.
(enrolment difficulties)
Sponsor:
Collaborator:
Vaincre la Mucoviscidose
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00391703
First received: October 23, 2006
Last updated: November 10, 2010
Last verified: November 2010

October 23, 2006
November 10, 2010
October 2006
November 2009   (final data collection date for primary outcome measure)
The six-minute walking distance [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
The six-minute walking distance
Complete list of historical versions of study NCT00391703 on ClinicalTrials.gov Archive Site
  • Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Inspiratory reserve volume (IRV), gasometry, dyspnea score [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Measurement of voluntary maximum force and non cooperative force of the quadriceps [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Area of quadriceps cross section measured with a scanner [ Time Frame: 1, 2 months ] [ Designated as safety issue: No ]
  • Quadriceps muscle mass [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Quality of life: CFQ14, BDI-TDI questionnaires [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Compliance with ergocycle rehabilitation [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • HOMA and QUICKI tests [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • Spirometry [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
Assessment of Quadriceps Muscle Electrostimulation Used as an Additional Procedure for Effort Retraining in Patients Suffering From Cystic Fibrosis Associated With Severe Pulmonary Dysfunction

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Cystic Fibrosis
  • Mucoviscidosis
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
September 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00391703
DCIC05/31
No
M. Eric Svahn, Clinical Research Department, Grenoble University Hospital
University Hospital, Grenoble
Vaincre la Mucoviscidose
Study Director: Claire Cracowski, Dr Pneumology Department of Grenoble University Hospital
University Hospital, Grenoble
November 2010

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