Cystic FibrosisPhase 4NCT02700282
Backpack Carrying in Children With Cystic Fibrosis
A Phase 4 study testing Backpack Carrying in people with Cystic Fibrosis, run by Groupe Hospitalier du Havre at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Backpack Carrying
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Cystic Fibrosis
- School-aged children (10 to 18)
Who cannot join
- Backpack carrying contraindication
- Acute exacerbation
- Impossible gait
- Other respiratory disease (asthma ...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Backpack Carrying
- Keywords
- Cystic fibrosis, Backpack carrying, Respiratory function, Children
- Medical subject headings
- Cystic Fibrosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Backpack CarryingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Backpack Carrying |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Function (Forced Vital Capacity)
Measured: Immediate assessment while standing
Secondary outcomes (7)
Lung function (Forced Expiratory Volume in 1 second)
Measured: Immediate assessment while standing
Respiratory Muscle Strength (MIP)
Maximal inspiratory pressure
Measured: Immediate assessment while standing
Respiratory Muscle Strength (MEP)
Maximal expiratory pressure
Measured: Immediate assessment while standing
Oxygen uptake (VO2)
Measured: During 12min treadmill gait
Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
Number of liters of air must be ventilated to consume 1 Liter of O2
Measured: During 12min treadmill gait
Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
Number of liters of air must be ventilated to reject 1 Liter of CO2
Measured: During 12min treadmill gait
Dyspnea (Borg Scale)
Measured: During 12min treadmill gait
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Le Roux, MD, Study director, Le Havre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700282
- Sponsor's protocol ID
- 2015-A01467-42
- Status last verified
- Dec 2016
- First submitted
- 23 Feb 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25584722Dockrell 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.
PubMed 26154227Thobani 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.
PubMed 25789173Ramsey 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.
PubMed 24948040Pastre 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.
PubMed 24884656
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Backpack Position on Lung Function and Oxygen Consumption in School-aged Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02700282
- Acronym / sponsor ID
- 2015-A01467-42
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Backpack carrying, Respiratory function, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis children | Experimental | Behavioral: Backpack CarryingChildren with Cystic Fibrosis will experience lung function measurement while backpack carrying. Aerobic Capacities will also be assessed during treadmill gait. |
| Healthy Children | Active comparator | Behavioral: Backpack CarryingHealthy Children will experience lung function measurement while backpack carrying. Aerobic Capacities will also be assessed during treadmill gait. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Cystic Fibrosis
- School-aged children (10 to 18)
Key exclusion criteria (4 listed)
- Backpack carrying contraindication
- Acute exacerbation
- Impossible gait
- Other respiratory disease (asthma ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Backpack CarryingA 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. | Behavioural | Cystic Fibrosis children, Healthy Children |
Primary outcome
Lung Function (Forced Vital Capacity)
Time frame: Immediate assessment while standing
7 secondary outcomes
Lung function (Forced Expiratory Volume in 1 second)
Time frame: Immediate assessment while standing
Respiratory Muscle Strength (MIP)
Time frame: Immediate assessment while standing
Respiratory Muscle Strength (MEP)
Time frame: Immediate assessment while standing
Oxygen uptake (VO2)
Time frame: During 12min treadmill gait
Ratio Ventilation/VO2 (Ventilation equivalent for oxygen)
Time frame: During 12min treadmill gait
Ratio Ventilation/VCO2 (Ventilation equivalent for carbon dioxide)
Time frame: During 12min treadmill gait
Dyspnea (Borg Scale)
Time frame: During 12min treadmill gait
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Background: PubMed 25584722Vieira 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.
- Background: PubMed 26154227Dockrell 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.
- Background: PubMed 25789173Thobani 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.
- Background: PubMed 24948040Ramsey 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.
- Background: PubMed 24884656Pastre 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.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal Le Roux, MD study director
Le Havre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Backpack Carrying in people with Cystic Fibrosis, run by Groupe Hospitalier du Havre at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Function (Forced Vital Capacity) (time frame: Immediate assessment while standing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700282, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.