NCT03519620

Brief Summary

To study the effects of swimming with water walking in children aged between 6 and 12 years in terms of spirometric values.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

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

Study Start

First participant enrolled

March 3, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

Same day

First QC Date

April 16, 2018

Last Update Submit

May 8, 2018

Conditions

Child DevelopmentChild ObesityBMI

Outcome Measures

Primary Outcomes (3)

  • Forced Vital Capacity

    described in liters

    12 weeks

  • Forced Expiratory Volume in 1 second

    described in liters

    12 weeks

  • Peak Expiratory Flow

    described in liters

    12 weeks

Secondary Outcomes (6)

  • Fat mass

    12 weeks

  • Weight

    12 weeks

  • Height

    12 weeks

  • weight and height will be combined to report BMI

    12 weeks

  • Muscle mass

    12 weeks

  • +1 more secondary outcomes

Study Arms (1)

SWWSV

EXPERIMENTAL

Spirometric Values: Forced Vital Capacity; Forced Expiratory Volume in 1 second; Peak Expiratory Flow

Other: SWWSV

Interventions

SWWSVOTHER

Behaviours to prevent child obesity

SWWSV

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children inside this age range;
  • water experience between 6 and 12 months
  • children with no other activities besides swimming

You may not qualify if:

  • Children with Asma;
  • Children with DPOC
  • Children with pulmonary limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Municipal Swimming Pools

Castelo Branco, 6000, Portugal

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • João B Oliveira, Master

    Castelo BRanco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 9, 2018

Study Start

March 3, 2018

Primary Completion

March 3, 2018

Study Completion

March 3, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)