NCT02700282

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

February 23, 2016

Last Update Submit

December 8, 2016

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisBackpack carryingRespiratory functionChildren

Outcome Measures

Primary Outcomes (1)

  • Lung Function (Forced Vital Capacity)

    Immediate assessment while standing

Secondary Outcomes (7)

  • Lung function (Forced Expiratory Volume in 1 second)

    Immediate assessment while standing

  • Respiratory Muscle Strength (MIP)

    Immediate assessment while standing

  • Respiratory Muscle Strength (MEP)

    Immediate assessment while standing

  • Oxygen uptake (VO2)

    During 12min treadmill gait

  • Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)

    During 12min treadmill gait

  • +2 more secondary outcomes

Study Arms (2)

Cystic Fibrosis children

EXPERIMENTAL

Children with Cystic Fibrosis will experience lung function measurement while backpack carrying. Aerobic Capacities will also be assessed during treadmill gait.

Behavioral: Backpack Carrying

Healthy Children

ACTIVE COMPARATOR

Healthy Children will experience lung function measurement while backpack carrying. Aerobic Capacities will also be assessed during treadmill gait.

Behavioral: Backpack Carrying

Interventions

Backpack CarryingBEHAVIORAL

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.

Cystic Fibrosis childrenHealthy Children

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Havre Hospital

Le Havre, 76290, France

Location

Related Publications (5)

  • 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. Epub 2015 Jan 13.

    PMID: 25584722BACKGROUND

  • 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. Epub 2015 Jun 11.

    PMID: 26154227BACKGROUND

  • 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. Epub 2015 Feb 18.

    PMID: 25789173BACKGROUND

  • 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. Epub 2014 Jun 19.

    PMID: 24948040BACKGROUND

  • Pastre J, Prevotat 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.

    PMID: 24884656BACKGROUND

MeSH Terms

Conditions

Cystic FibrosisRespiratory Aspiration

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pascal Le Roux, MD

    Le Havre Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 7, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)