Clinical trial NCT00391703: Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Mucoviscidosis
Keywords: Cystic fibrosis
mucoviscidosis
electrostimulation
retraining
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Vaincre la Mucoviscidose
First posted: 2006-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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.

Primary outcomes:
measure: The six-minute walking distance
timeFrame: 0, 1, 2 months
Secondary outcomes:
measure: Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation
timeFrame: 1 month
measure: Inspiratory reserve volume (IRV), gasometry, dyspnea score
timeFrame: 0, 1, 2 months
measure: Measurement of voluntary maximum force and non cooperative force of the quadriceps
timeFrame: 0, 1, 2 months
measure: Area of quadriceps cross section measured with a scanner
timeFrame: 1, 2 months
measure: Quadriceps muscle mass
timeFrame: 0, 1, 2 months
measure: Quality of life: CFQ14, BDI-TDI questionnaires
timeFrame: 0, 1, 2 months
measure: Compliance with ergocycle rehabilitation
timeFrame: 1 month
measure: HOMA and QUICKI tests
timeFrame: 0, 1, 2 months
measure: Spirometry
timeFrame: 0, 1, 2 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Pneumology Department of Grenoble University Hospital
state: Isere
city: Lyon
country: France
facility: Pneumology Department of Lyon University Hospital
state: Rhone
Study officials:
affiliation: Pneumology Department of Grenoble University Hospital
name: Claire Cracowski, Dr
role: STUDY_DIRECTOR
References:
citation: Pin I, Grenet D, Scheid P, Domblides P, Stern M, Hubert D. [Specific aspects and care of lung involvement in adults with cystic fibrosis]. Rev Mal Respir. 2000 Aug;17(3 Pt 2):758-78. French.
citation: de Meer K, Gulmans VA, van Der Laag J. Peripheral muscle weakness and exercise capacity in children with cystic fibrosis. Am J Respir Crit Care Med. 1999 Mar;159(3):748-54. doi: 10.1164/ajrccm.159.3.9802112.
citation: Selvadurai HC, Allen J, Sachinwalla T, Macauley J, Blimkie CJ, Van Asperen PP. Muscle function and resting energy expenditure in female athletes with cystic fibrosis. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1476-80. doi: 10.1164/rccm.200303-363OC. Epub 2003 Sep 18.
citation: Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9. doi: 10.1164/ajrccm/147.4.865.
citation: Elkin SL, Williams L, Moore M, Hodson ME, Rutherford OM. Relationship of skeletal muscle mass, muscle strength and bone mineral density in adults with cystic fibrosis. Clin Sci (Lond). 2000 Oct;99(4):309-14.
citation: de Meer K, Jeneson JA, Gulmans VA, van der Laag J, Berger R. Efficiency of oxidative work performance of skeletal muscle in patients with cystic fibrosis. Thorax. 1995 Sep;50(9):980-3. doi: 10.1136/thx.50.9.980.
citation: Moser C, Tirakitsoontorn P, Nussbaum E, Newcomb R, Cooper DM. Muscle size and cardiorespiratory response to exercise in cystic fibrosis. Am J Respir Crit Care Med. 2000 Nov;162(5):1823-7. doi: 10.1164/ajrccm.162.5.2003057.
citation: Vivodtzev I, Decorte N, Wuyam B, Gonnet N, Durieu I, Levy P, Cracowski JL, Cracowski C. Benefits of neuromuscular electrical stimulation prior to endurance training in patients with cystic fibrosis and severe pulmonary dysfunction. Chest. 2013 Feb 1;143(2):485-493. doi: 10.1378/chest.12-0584.