Backpack Carrying in Children With Cystic Fibrosis

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Backpack Carrying

• Registration Number: NCT02700282
• Lead Sponsor: Groupe Hospitalier du Havre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cystic Fibrosis children	Backpack Carrying	Children with Cystic Fibrosis will experience lung function measurement while backpack carrying. Aerobic Capacities will also be assessed during treadmill gait.
Healthy Children	Backpack Carrying	Healthy Children will experience lung function measurement while backpack carrying. Aerobic Capacities will also be assessed during treadmill gait.

Primary Outcome Measures

Name	Time	Method
Lung Function (Forced Vital Capacity)	Immediate assessment while standing

Secondary Outcome Measures

Name	Time	Method
Lung function (Forced Expiratory Volume in 1 second)	Immediate assessment while standing
Respiratory Muscle Strength (MIP)	Immediate assessment while standing	Maximal inspiratory pressure
Respiratory Muscle Strength (MEP)	Immediate assessment while standing	Maximal expiratory pressure
Oxygen uptake (VO2)	During 12min treadmill gait
Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)	During 12min treadmill gait	Number of liters of air must be ventilated to consume 1 Liter of O2
Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)	During 12min treadmill gait	Number of liters of air must be ventilated to reject 1 Liter of CO2
Dyspnea (Borg Scale)	During 12min treadmill gait

Trial Locations

Locations (1)

Le Havre Hospital; 🇫🇷 Le Havre, France