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Backpack Carrying in Children With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Backpack Carrying

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring Cystic fibrosis, Backpack carrying, Respiratory function, Children

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Cystic Fibrosis
School-aged children (10 to 18)

Exclusion Criteria:

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

Sites / Locations

Le Havre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cystic Fibrosis children

Healthy Children

Arm Description

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

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

Outcomes

Primary Outcome Measures

Lung Function (Forced Vital Capacity)

Secondary Outcome Measures

Lung function (Forced Expiratory Volume in 1 second)

Respiratory Muscle Strength (MIP)

Maximal inspiratory pressure

Respiratory Muscle Strength (MEP)

Maximal expiratory pressure

Oxygen uptake (VO2)

Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)

Number of liters of air must be ventilated to consume 1 Liter of O2

Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)

Number of liters of air must be ventilated to reject 1 Liter of CO2

Dyspnea (Borg Scale)

Full Information

NCT ID

NCT02700282

First Posted

February 23, 2016

Last Updated

December 8, 2016

Sponsor

Groupe Hospitalier du Havre

1. Study Identification

Unique Protocol Identification Number

NCT02700282

Brief Title

Backpack Carrying in Children With Cystic Fibrosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Groupe Hospitalier du Havre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Cystic fibrosis, Backpack carrying, Respiratory function, Children

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cystic Fibrosis children

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy Children

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Backpack Carrying

Intervention Description

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 Measure Information:

Title

Lung Function (Forced Vital Capacity)

Time Frame

Immediate assessment while standing

Secondary Outcome Measure Information:

Title

Lung function (Forced Expiratory Volume in 1 second)

Time Frame

Immediate assessment while standing

Title

Respiratory Muscle Strength (MIP)

Description

Maximal inspiratory pressure

Time Frame

Immediate assessment while standing

Title

Respiratory Muscle Strength (MEP)

Description

Maximal expiratory pressure

Time Frame

Immediate assessment while standing

Title

Oxygen uptake (VO2)

Time Frame

During 12min treadmill gait

Title

Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)

Description

Number of liters of air must be ventilated to consume 1 Liter of O2

Time Frame

During 12min treadmill gait

Title

Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)

Description

Number of liters of air must be ventilated to reject 1 Liter of CO2

Time Frame

During 12min treadmill gait

Title

Dyspnea (Borg Scale)

Time Frame

During 12min treadmill gait

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cystic Fibrosis School-aged children (10 to 18) Exclusion Criteria: Backpack carrying contraindication Acute exacerbation Impossible gait Other respiratory disease (asthma ...)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal Le Roux, MD

Organizational Affiliation

Le Havre Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Le Havre Hospital

City

Le Havre

ZIP/Postal Code

76290

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25584722

Citation

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.

Results Reference

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PubMed Identifier

26154227

Citation

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.

Results Reference

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PubMed Identifier

25789173

Citation

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.

Results Reference

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PubMed Identifier

24948040

Citation

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.

Results Reference

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PubMed Identifier

24884656

Citation

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.

Results Reference

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Backpack Carrying in Children With Cystic Fibrosis

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