Backpack Carrying in Children With Cystic Fibrosis

December 8, 2016 updated by: Groupe Hospitalier du Havre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Havre, France, 76290
        • Le Havre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cystic Fibrosis children

Children with Cystic Fibrosis will experience lung function measurement while backpack carrying.

Aerobic Capacities will also be assessed during treadmill gait.
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.
Active Comparator: Healthy Children

Healthy Children will experience lung function measurement while backpack carrying.

Aerobic Capacities will also be assessed during treadmill gait.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lung Function (Forced Vital Capacity)
Time Frame: Immediate assessment while standing
Immediate assessment while standing

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier du Havre

Investigators

  • Study Director: Pascal Le Roux, MD, Le Havre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01467-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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