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

Cystic Fibrosis Clinical Trial

— STIMUCO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00391703
• Other study ID #: DCIC05/31
• Status: Terminated
• Phase: N/A
• First received: October 23, 2006
• Last updated: November 10, 2010
• Start date: October 2006
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Mucoviscidosis

Intervention

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
• Usual sport activity
Usual sport activity performed prior to an endurance retraining program using a cycloergometer

Locations

Country	Name	City	State
France	Pneumology Department of Grenoble University Hospital	Grenoble	Isere
France	Pneumology Department of Lyon University Hospital	Lyon	Rhone

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Vaincre la Mucoviscidose

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. French. — View 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. Epub 2003 Sep 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The six-minute walking distance		0, 1, 2 months	No
Secondary	Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation		1 month	No
Secondary	Inspiratory reserve volume (IRV), gasometry, dyspnea score		0, 1, 2 months	No
Secondary	Measurement of voluntary maximum force and non cooperative force of the quadriceps		0, 1, 2 months	No
Secondary	Area of quadriceps cross section measured with a scanner		1, 2 months	No
Secondary	Quadriceps muscle mass		0, 1, 2 months	No
Secondary	Quality of life: CFQ14, BDI-TDI questionnaires		0, 1, 2 months	No
Secondary	Compliance with ergocycle rehabilitation		1 month	No
Secondary	HOMA and QUICKI tests		0, 1, 2 months	No
Secondary	Spirometry		0, 1, 2 months	No