Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Backpack Carrying in Children With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02700282
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Behavioral: Backpack Carrying Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Backpack Position on Lung Function and Oxygen Consumption in School-aged Children With Cystic Fibrosis
Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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.




Primary Outcome Measures :
  1. Lung Function (Forced Vital Capacity) [ Time Frame: Immediate assessment while standing ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700282


Locations
Layout table for location information
France
Le Havre Hospital
Le Havre, France, 76290
Sponsors and Collaborators
Groupe Hospitalier du Havre
Investigators
Layout table for investigator information
Study Director: Pascal Le Roux, MD Le Havre Hospital

Publications:
Layout table for additonal information
Responsible Party: Groupe Hospitalier du Havre
ClinicalTrials.gov Identifier: NCT02700282     History of Changes
Other Study ID Numbers: 2015-A01467-42
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Groupe Hospitalier du Havre:
Cystic fibrosis
Backpack carrying
Respiratory function
Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases