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

NCT00391703 | Terminated

• 1 other identifier: DCIC05/31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis; Mucoviscidosis

Keywords

Cystic fibrosis; mucoviscidosis; electrostimulation; retraining

Outcome Measures

Primary Outcomes (1)

• The six-minute walking distance

  0, 1, 2 months

Secondary Outcomes (9)

• 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

Study Arms (2)

1

EXPERIMENTAL

Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer

Behavioral: Electrostimulation programme: using a cycloergometer

2

ACTIVE COMPARATOR

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

Behavioral: Usual sport activity

Interventions

Electrostimulation programme: using a cycloergometer BEHAVIORAL

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

1

Usual sport activity BEHAVIORAL

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Contraindication to application of magnetic field
• Pacemaker
• History of neurosurgical intervention
• Presence of metallic particles near the stimulation site.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Vaincre la Mucoviscidose: collaborator

Study Sites (2)

Pneumology Department of Grenoble University Hospital

Grenoble, Isere, 38043, France

Location

Pneumology Department of Lyon University Hospital

Lyon, Rhone, 69000, France

Location

Related Publications (8)

• 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.

  PMID: 11076386 BACKGROUND

• 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.

  PMID: 10051246 BACKGROUND

• 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.

  PMID: 14500260 BACKGROUND

• 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.

  PMID: 8466121 BACKGROUND

• 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.

  PMID: 10995596 BACKGROUND

• 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.

  PMID: 8539680 BACKGROUND

• 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.

  PMID: 11069820 BACKGROUND

• 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.

  PMID: 22911373 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Claire Cracowski, Dr

  Pneumology Department of Grenoble University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 24, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: September 1, 2010
• Last Updated: November 11, 2010

Record last verified: 2010-11

Locations

FR (2)