Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT03519620
Status:
COMPLETED
Last Update Posted:
2018-05-09
First Post:
2018-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swimming and Water Walking on Spirometry Values
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Vital Capacity', 'timeFrame': '12 weeks', 'description': 'described in liters'}, {'measure': 'Forced Expiratory Volume in 1 second', 'timeFrame': '12 weeks', 'description': 'described in liters'}, {'measure': 'Peak Expiratory Flow', 'timeFrame': '12 weeks', 'description': 'described in liters'}], 'secondaryOutcomes': [{'measure': 'Fat mass', 'timeFrame': '12 weeks', 'description': 'described in percentage'}, {'measure': 'Weight', 'timeFrame': '12 weeks', 'description': 'described in kilograms'}, {'measure': 'Height', 'timeFrame': '12 weeks', 'description': 'described in meters'}, {'measure': 'weight and height will be combined to report BMI', 'timeFrame': '12 weeks', 'description': 'BMI described in kg/m\\^2'}, {'measure': 'Muscle mass', 'timeFrame': '12 weeks', 'description': 'described in percentage'}, {'measure': 'waist circumference', 'timeFrame': '12 weeks', 'description': 'described in centimeters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Development', 'Child Obesity', 'BMI']}, 'descriptionModule': {'briefSummary': 'To study the effects of swimming with water walking in children aged between 6 and 12 years in terms of spirometric values.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children inside this age range;\n* water experience between 6 and 12 months\n* children with no other activities besides swimming\n\nExclusion Criteria:\n\n* Children with Asma;\n* Children with DPOC\n* Children with pulmonary limitations.'}, 'identificationModule': {'nctId': 'NCT03519620', 'acronym': 'ESWWSV', 'briefTitle': 'Swimming and Water Walking on Spirometry Values', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Politécnico de Castelo Branco'}, 'officialTitle': 'The Effects of Swimming and Swimming Complemented With Water Walking on Spirometry Values', 'orgStudyIdInfo': {'id': 'IPCB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SWWSV', 'description': 'Spirometric Values: Forced Vital Capacity; Forced Expiratory Volume in 1 second; Peak Expiratory Flow', 'interventionNames': ['Other: SWWSV']}], 'interventions': [{'name': 'SWWSV', 'type': 'OTHER', 'description': 'Behaviours to prevent child obesity', 'armGroupLabels': ['SWWSV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Castelo Branco', 'country': 'Portugal', 'facility': 'Municipal Swimming Pools', 'geoPoint': {'lat': 39.82364, 'lon': -7.49101}}], 'overallOfficials': [{'name': 'João B Oliveira, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Castelo BRanco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Politécnico de Castelo Branco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Municipal Swimming Clube', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Samuel Honório', 'investigatorAffiliation': 'Instituto Politécnico de Castelo Branco'}}}}