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OpenTrials
Completed

NCT Number: NCT02700282

Backpack Carrying in 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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Le Havre Hospital

Le Havre, 76290, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Backpack Carrying

Behavioral

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.

Primary outcomes

  1. Lung Function (Forced Vital Capacity)

    Time frame: Immediate assessment while standing

Secondary outcomes

  1. Lung function (Forced Expiratory Volume in 1 second)

    Time frame: Immediate assessment while standing

  2. Respiratory Muscle Strength (MIP)

    Time frame: Immediate assessment while standing

    Maximal inspiratory pressure

  3. Respiratory Muscle Strength (MEP)

    Time frame: Immediate assessment while standing

    Maximal expiratory pressure

  4. Oxygen uptake (VO2)

    Time frame: During 12min treadmill gait

  5. 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

  6. 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

  7. Dyspnea (Borg Scale)

    Time frame: During 12min treadmill gait

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier du Havre

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 7, 2016
Registry last updated
Dec 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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