Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
27 participants
INTERVENTIONAL
2016-03-31
2016-11-30
Brief Summary
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School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle strength is also impaired.
No studies assessed aerobic capacities during children's gait while carrying a backpack.
The investigators hypothesized that backpack carrying will induce an acute decline in lung function in children with cystic fibrosis compared to healthy children. Investigators also hypothesized that aerobic capacities will be impaired.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Cystic Fibrosis children
Children with Cystic Fibrosis will experience lung function measurement while backpack carrying.
Aerobic Capacities will also be assessed during treadmill gait.
Backpack Carrying
A 12,5% of body weight backpack will be used for each measurement. Lung function will be assessed while carrying a double strap backpack, a mono shoulder backpack and without a backpack.
Healthy Children
Healthy Children will experience lung function measurement while backpack carrying.
Aerobic Capacities will also be assessed during treadmill gait.
Backpack Carrying
A 12,5% of body weight backpack will be used for each measurement. Lung function will be assessed while carrying a double strap backpack, a mono shoulder backpack and without a backpack.
Interventions
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Backpack Carrying
A 12,5% of body weight backpack will be used for each measurement. Lung function will be assessed while carrying a double strap backpack, a mono shoulder backpack and without a backpack.
Eligibility Criteria
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Inclusion Criteria
* School-aged children (10 to 18)
Exclusion Criteria
* Acute exacerbation
* Impossible gait
* Other respiratory disease (asthma ...)
10 Years
18 Years
ALL
Yes
Sponsors
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Groupe Hospitalier du Havre
OTHER
Responsible Party
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Principal Investigators
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Pascal Le Roux, MD
Role: STUDY_DIRECTOR
Le Havre Hospital
Locations
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Le Havre Hospital
Le Havre, , France
Countries
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References
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Vieira AC, Ribeiro F. Impact of backpack type on respiratory muscle strength and lung function in children. Ergonomics. 2015;58(6):1005-11. doi: 10.1080/00140139.2014.997803. Epub 2015 Jan 13.
Dockrell S, Simms C, Blake C. Schoolbag carriage and schoolbag-related musculoskeletal discomfort among primary school children. Appl Ergon. 2015 Nov;51:281-90. doi: 10.1016/j.apergo.2015.05.009. Epub 2015 Jun 11.
Thobani A, Alvarez JA, Blair S, Jackson K, Gottlieb ER, Walker S, Tangpricha V. Higher mobility scores in patients with cystic fibrosis are associated with better lung function. Pulm Med. 2015;2015:423219. doi: 10.1155/2015/423219. Epub 2015 Feb 18.
Ramsey KA, Ranganathan S. Interpretation of lung function in infants and young children with cystic fibrosis. Respirology. 2014 Aug;19(6):792-9. doi: 10.1111/resp.12329. Epub 2014 Jun 19.
Pastre J, Prevotat A, Tardif C, Langlois C, Duhamel A, Wallaert B. Determinants of exercise capacity in cystic fibrosis patients with mild-to-moderate lung disease. BMC Pulm Med. 2014 Apr 30;14:74. doi: 10.1186/1471-2466-14-74.
Other Identifiers
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2015-A01467-42
Identifier Type: -
Identifier Source: org_study_id