Assessment of Quadriceps Muscle Electrostimulation Used in Patients Suffering From Cystic Fibrosis - Full Text View

Purpose

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	Intervention
Cystic Fibrosis Mucoviscidosis	Behavioral: Electrostimulation programme: using a cycloergometer Behavioral: Usual sport activity

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

The six-minute walking distance [ Time Frame: 0, 1, 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	October 2006
Study Completion Date:	September 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

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.

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.

Lands LC, Heigenhauser GJ, Jones NL. Respiratory and peripheral muscle function in cystic fibrosis. Am Rev Respir Dis. 1993 Apr;147(4):865-9.

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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):485-93.

Responsible Party:	M. Eric Svahn, Clinical Research Department, Grenoble University Hospital
ClinicalTrials.gov Identifier:	NCT00391703 History of Changes
Other Study ID Numbers:	DCIC05/31
Study First Received:	October 23, 2006
Last Updated:	November 10, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:

Cystic fibrosis
mucoviscidosis
electrostimulation
retraining

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Stress, Psychological
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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