Backpack Carrying in Children With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Impact of Backpack Position on Lung Function and Oxygen Consumption in School-aged Children With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700282
• Other study ID #: 2015-A01467-42
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2016
• Last updated: December 8, 2016
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Groupe Hospitalier du Havre
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Cystic Fibrosis

• School-aged children (10 to 18)

Exclusion Criteria:

• Backpack carrying contraindication

• Acute exacerbation

• Impossible gait

• Other respiratory disease (asthma ...)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	Le Havre Hospital	Le Havre

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Pastré J, Prévotat 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Function (Forced Vital Capacity)		Immediate assessment while standing	No
Secondary	Lung function (Forced Expiratory Volume in 1 second)		Immediate assessment while standing	No
Secondary	Respiratory Muscle Strength (MIP)	Maximal inspiratory pressure	Immediate assessment while standing	No
Secondary	Respiratory Muscle Strength (MEP)	Maximal expiratory pressure	Immediate assessment while standing	No
Secondary	Oxygen uptake (VO2)		During 12min treadmill gait	No
Secondary	Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)	Number of liters of air must be ventilated to consume 1 Liter of O2	During 12min treadmill gait	No
Secondary	Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)	Number of liters of air must be ventilated to reject 1 Liter of CO2	During 12min treadmill gait	No
Secondary	Dyspnea (Borg Scale)		During 12min treadmill gait	No