Clinical trial NCT02700282: Backpack Carrying in Children With Cystic Fibrosis
Official title: Impact of Backpack Position on Lung Function and Oxygen Consumption in School-aged Children With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Backpack carrying
Respiratory function
Children
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a progressive decline in lung function.

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.


Eligibility criteria: Inclusion Criteria:

* Cystic Fibrosis
* School-aged children (10 to 18)

Exclusion Criteria:

* Backpack carrying contraindication
* Acute exacerbation
* Impossible gait
* Other respiratory disease (asthma ...)

Primary outcomes:
measure: Lung Function (Forced Vital Capacity)
timeFrame: Immediate assessment while standing
Secondary outcomes:
measure: Lung function (Forced Expiratory Volume in 1 second)
timeFrame: Immediate assessment while standing
measure: Respiratory Muscle Strength (MIP)
timeFrame: Immediate assessment while standing
measure: Respiratory Muscle Strength (MEP)
timeFrame: Immediate assessment while standing
measure: Oxygen uptake (VO2)
timeFrame: During 12min treadmill gait
measure: Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
timeFrame: During 12min treadmill gait
measure: Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
timeFrame: During 12min treadmill gait
measure: Dyspnea (Borg Scale)
timeFrame: During 12min treadmill gait
Other outcomes:
Locations:
city: Le Havre
country: France
facility: Le Havre Hospital
Study officials:
affiliation: Le Havre Hospital
name: Pascal Le Roux, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.