Cystic Fibrosis Clinical Trial
— STIMUCOOfficial 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
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Pneumology Department of Grenoble University Hospital | Grenoble | Isere |
France | Pneumology Department of Lyon University Hospital | Lyon | Rhone |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | Vaincre la Mucoviscidose |
France,
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
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 |
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