Child DevelopmentESWWSVNCT03519620
Swimming and Water Walking on Spirometry Values
A study testing SWWSV in people with Child Development and Child Obesity, run by Instituto Politécnico de Castelo Branco at 1 site in Portugal.
Trial summary
To study the effects of swimming with water walking in children aged between 6 and 12 years in terms of spirometric values. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Obesity, BMI
- What is being tested?
- SWWSV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Mar 2018to 3 Mar 2018
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children inside this age range;
- water experience between 6 and 12 months
- children with no other activities besides swimming
Who cannot join
- Children with Asma;
- Children with DPOC
- Children with pulmonary limitations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Swimming and Swimming Complemented With Water Walking on Spirometry Values
To study the effects of swimming with water walking in children aged between 6 and 12 years in terms of spirometric values.
Read the detailed description
The present research aims to verify if there are differences in body composition and spirometric values in children aged between 6 and 12 years who practice swimming complemented with water walking at the end of each session and those who only practice swimming. The sample consisted of 28 individuals aged 6 to 12 years and was divided into two groups: swimming group (SG) with 9 children and swimming complemented with water walking group (SWWG) of 19 children. In this study, the investigators wanted to know which were the benefits in body composition and for that purpose used a bio-impedance scale Targa Silvercrest Z29777A (Germany), and an anthropometric tape to measure the waist circumference. To calculate the spirometric values, namely forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and even peak expiratory flow (PEF) a Cosmed Microquark spirometer was used. In terms of statistical procedures, the investigators used the program Statistical Package for the Social Sciences version number 20 (SPSS 20.0). The investigators used descriptive statistics (minimum, maximum, means and standard deviations), the Shapiro Wilk test for testing the normality of the sample, inferential statistics (non-parametric Mann-Whitney tests, Friedman's Anova, and for the calculation of the effect magnitude the d-Cohen test). After the data treatment, regarding the inter-group analysis (comparison between the swimming group and the swimming group with water walking) the investigators observed that there were significant differences in three variables at the end of the study, that is, at the end of the 3 moments. These variables were weight relative to body composition, forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF), these values are relative to the spirometry evaluation. Concerning intra-group differences (improvement in the swimming group and the swimming with water walking group in the three moments evaluated), the SWWG showed significant improvements in the variables of weight, muscle mass, fat mass, percentage of water, body mass index (BMI), body percentiles, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1).
- Conditions
- Child Development, Child Obesity, BMI
- Being tested
- SWWSV
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWWSVOther
Behaviours to prevent child obesity
| Study group | Role | What they receive |
|---|---|---|
| SWWSV | Experimental | Spirometric Values: Forced Vital Capacity; Forced Expiratory Volume in 1 second; Peak Expiratory Flow Receives: Other: SWWSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity
described in liters
Measured: 12 weeks
Forced Expiratory Volume in 1 second
described in liters
Measured: 12 weeks
Peak Expiratory Flow
described in liters
Measured: 12 weeks
Secondary outcomes (6)
Fat mass
described in percentage
Measured: 12 weeks
Weight
described in kilograms
Measured: 12 weeks
Height
described in meters
Measured: 12 weeks
weight and height will be combined to report BMI
BMI described in kg/m^2
Measured: 12 weeks
Muscle mass
described in percentage
Measured: 12 weeks
waist circumference
described in centimeters
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start3 Mar 2018
- Primary completion3 Mar 2018
- Study completion3 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Castelo Branco
- Sponsor type
- University, hospital or other
- Collaborators
- Municipal Swimming Clube
- Responsible party
- Principal investigator, Samuel Honório, Instituto Politécnico de Castelo Branco
- Investigators
- João B Oliveira, Master, Principal investigator, Castelo BRanco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519620
- Sponsor's protocol ID
- IPCB
- Acronym
- ESWWSV
- Status last verified
- May 2018
- First submitted
- 16 Apr 2018
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Swimming and Swimming Complemented With Water Walking on Spirometry Values
- ClinicalTrials.gov ID
- NCT03519620
- Acronym / sponsor ID
- ESWWSV / IPCB
- Conditions
- Child Development, Child Obesity, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Instituto Politécnico de Castelo BrancoUniversity, hospital or other
- Collaborators
- Municipal Swimming Clube
- Study start
- 3 Mar 2018 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 9 May 2018 (actual)
- 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.
To study the effects of swimming with water walking in children aged between 6 and 12 years in terms of spirometric values.
Detailed description
The present research aims to verify if there are differences in body composition and spirometric values in children aged between 6 and 12 years who practice swimming complemented with water walking at the end of each session and those who only practice swimming. The sample consisted of 28 individuals aged 6 to 12 years and was divided into two groups: swimming group (SG) with 9 children and swimming complemented with water walking group (SWWG) of 19 children. In this study, the investigators wanted to know which were the benefits in body composition and for that purpose used a bio-impedance scale Targa Silvercrest Z29777A (Germany), and an anthropometric tape to measure the waist circumference. To calculate the spirometric values, namely forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and even peak expiratory flow (PEF) a Cosmed Microquark spirometer was used. In terms of statistical procedures, the investigators used the program Statistical Package for the Social Sciences version number 20 (SPSS 20.0). The investigators used descriptive statistics (minimum, maximum, means and standard deviations), the Shapiro Wilk test for testing the normality of the sample, inferential statistics (non-parametric Mann-Whitney tests, Friedman's Anova, and for the calculation of the effect magnitude the d-Cohen test). After the data treatment, regarding the inter-group analysis (comparison between the swimming group and the swimming group with water walking) the investigators observed that there were significant differences in three variables at the end of the study, that is, at the end of the 3 moments. These variables were weight relative to body composition, forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF), these values are relative to the spirometry evaluation. Concerning intra-group differences (improvement in the swimming group and the swimming with water walking group in the three moments evaluated), the SWWG showed significant improvements in the variables of weight, muscle mass, fat mass, percentage of water, body mass index (BMI), body percentiles, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SWWSV | Experimental | Other: SWWSVSpirometric Values: Forced Vital Capacity; Forced Expiratory Volume in 1 second; Peak Expiratory Flow |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children inside this age range;
- water experience between 6 and 12 months
- children with no other activities besides swimming
Key exclusion criteria (3 listed)
- Children with Asma;
- Children with DPOC
- Children with pulmonary limitations.
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 |
|---|---|---|
| SWWSVBehaviours to prevent child obesity | Other | SWWSV |
Primary outcome
Forced Vital Capacity
Time frame: 12 weeks
described in liters
Forced Expiratory Volume in 1 second
Time frame: 12 weeks
described in liters
Peak Expiratory Flow
Time frame: 12 weeks
described in liters
6 secondary outcomes
Fat mass
Time frame: 12 weeks
Weight
Time frame: 12 weeks
Height
Time frame: 12 weeks
weight and height will be combined to report BMI
Time frame: 12 weeks
Muscle mass
Time frame: 12 weeks
waist circumference
Time frame: 12 weeks
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 May 2018.
- Individual participant dataSharing planned: No
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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.
João B Oliveira, Master principal investigator
Castelo BRanco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWWSV in people with Child Development and Child Obesity, run by Instituto Politécnico de Castelo Branco at 1 site in Portugal.
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 3 inclusion and 3 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 May 2018. 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 Portugal. 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.
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?
Forced Vital Capacity (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2018.