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

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.

Study Overview

• Status: Terminated
• Conditions: Cystic Fibrosis; Mucoviscidosis
• Intervention / Treatment: Behavioral: Electrostimulation programme: using a cycloergometer; Behavioral: Usual sport activity

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Isere
    • Grenoble, Isere, France, 38043
      • Pneumology Department of Grenoble University Hospital
  • Rhone
    • Lyon, Rhone, France, 69000
      • Pneumology Department of Lyon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The six-minute walking distance	0, 1, 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation	1 month
Inspiratory reserve volume (IRV), gasometry, dyspnea score	0, 1, 2 months
Measurement of voluntary maximum force and non cooperative force of the quadriceps	0, 1, 2 months
Area of quadriceps cross section measured with a scanner	1, 2 months
Quadriceps muscle mass	0, 1, 2 months
Quality of life: CFQ14, BDI-TDI questionnaires	0, 1, 2 months
Compliance with ergocycle rehabilitation	1 month
HOMA and QUICKI tests	0, 1, 2 months
Spirometry	0, 1, 2 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Vaincre la Mucoviscidose
• Investigators: Study Director: Claire Cracowski, Dr, Pneumology Department of Grenoble University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. doi: 10.1136/thx.50.9.980.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: October 23, 2006
• First Submitted That Met QC Criteria: October 23, 2006
• First Posted (Estimate): October 24, 2006

Study Record Updates

• Last Update Posted (Estimate): November 11, 2010
• Last Update Submitted That Met QC Criteria: November 10, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Cystic fibrosis; electrostimulation; mucoviscidosis; retraining
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: DCIC05/31