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enrolment difficulties
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| Name | Class |
|---|---|
| Vaincre la Mucoviscidose | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Quadriceps electrostimulation program, performed prior to an endurance retraining program using a cycloergometer |
|
| 2 | Active Comparator | Usual sport activity, performed prior to an endurance retraining program using a cycloergometer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The six-minute walking distance | 0, 1, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cycloergometer test: maximum power, maximum oxygen consumption, minute ventilation | 1 month | |
| Inspiratory reserve volume (IRV), gasometry, dyspnea score | 0, 1, 2 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Cracowski, Dr | Pneumology Department of Grenoble University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneumology Department of Grenoble University Hospital | Grenoble | Isere | 38043 | France | ||
| Pneumology Department of Lyon University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11076386 | Background | 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. | |
| 10051246 | 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. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Usual sport activity | Behavioral | Usual sport activity performed prior to an endurance retraining program using a cycloergometer |
|
| 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 |
| Lyon |
| Rhone |
| 69000 |
| France |
| 14500260 | 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. |
| 8466121 | 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. |
| 10995596 | 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. |
| 8539680 | 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. |
| 11069820 | 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. |
| 22911373 | Derived | 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |