Ignite Creation Date:
2025-12-17 @ 1:44 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT07107061
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-07-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PILATES AND AEROBIC TRAINING ON BODY COMPOSITION IN YOUNG ADULTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Researcher responsible for randomization'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of total body fat mass (%)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Percentage of total body fat mass assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Total lean mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Absolute total body lean mass assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Total fat mass (Kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Absolute total body fat mass assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Total lean mass adjusted for height (kg/m²)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Total lean mass adjusted for height assessed by dual-energy X-ray absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Trunk fat mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Trunk fat mass assessed by dual-energy X-ray densitometry (DXA)'}, {'measure': 'Upper limb fat mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Upper limb fat mass assessed by dual-energy X-ray densitometry (DXA)'}, {'measure': 'Lower limb fat mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Lower limb fat mass assessed by dual-energy X-ray densitometry (DXA)'}, {'measure': 'Trunk lean mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Trunk lean mass assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Upper limb lean mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Upper limb lean mass assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Lower limb lean mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Lower limb lean mass assessed by dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Total body mass (kg)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Total body mass assessed by precision scale'}, {'measure': 'Body mass index (kg/m²)', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Body mass index calculated by the ratio of total body mass (measured by a precision scale) to height (measured by a stadiometer) squared'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Improved Body Composition']}, 'descriptionModule': {'briefSummary': "Pilates exercises have been shown to be effective for a range of outcomes; however, it is unclear whether they can effectively contribute to fat mass reduction, especially when compared with a technique known to be effective for this purpose, such as aerobic training. Furthermore, Pilates' potential for increasing lean mass also requires further investigation. The aim of this study was to assess the effectiveness of Pilates compared with aerobic training, as well as the combination of these activities, on body composition in young adults. Eighty women aged 18 to 40 years were randomized to four groups: Pilates (n = 20), aerobic (n = 20), Pilates plus aerobic (n = 20), and control (n = 20). Body composition was assessed by dual-energy X-ray absorptiometry (DXA), considering: total fat mass (kg), percentage of total fat mass (%), total lean mass (kg), and total lean mass adjusted for height (kg/m²). Additionally, total body mass (kg) and body mass index (BMI) (kg/m2) values were considered. The interventions were carried out for 12 weeks, three times a week, lasting 60 minutes/session. Analyses were performed by intention-to-treat and per protocol."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female;\n* Age between 18 and 35 years;\n* Not having exercised in the last 6 months;\n* Agreeing not to perform any other type of exercise during the study period;\n* Being fit to exercise according to the Physical Activity Readiness Questionnaire (PAR-Q) criteria;\n* Not having musculoskeletal or neurological disorders that could affect exercise performance;\n* Not having known cardiovascular or respiratory diseases;\n* Not having cognitive impairment that leads to the inability to follow simple commands;\n* Not being a smoker;\n* Not being pregnant;\n* Not being on any specific diets.\n\nExclusion Criteria:\n\n* Refusing to sign the informed consent form;\n* Unable to complete the pre-intervention assessment procedures.'}, 'identificationModule': {'nctId': 'NCT07107061', 'briefTitle': 'PILATES AND AEROBIC TRAINING ON BODY COMPOSITION IN YOUNG ADULTS', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual do Norte do Parana'}, 'officialTitle': 'Pilates and Aerobic Training on Body Composition in Young Adults: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GPASD_001_2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates', 'description': 'A total of 13 exercises were selected for the Pilates group, including two stretching exercises and 11 strengthening exercises for the main muscle groups. Mat exercises and equipment exercises (Ladder Barrel, Cadillac, Step Chair, Reformer, Springboard, and Small Barrel) will be used. Two protocols will be adopted for progression (protocol 1: weeks 1-6; protocol 2: weeks 7-12). Two sets of 10 repetitions will be performed, with a 30-second rest between sets and exercises. The two-by-two rule will be used to increase the load. In this case, the load will increase when the participant performs ≥ 2 repetitions above their target of 10 repetitions in the last set, in two consecutive training sessions. The interventions will last 12 weeks, three times a week, for 60 minutes.', 'interventionNames': ['Other: Pilates exercises']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic', 'description': 'The aerobic group will perform walking/running exercises on a treadmill using the extensive interval training method. To define the intensity and periodization of the training, the running speed associated with V̇O2max (vV̇O2max), second ventilatory threshold (vLV2), and average speed between vV̇O2max and vLV2 (v50%Δ) will be used as reference. These parameters will be obtained from a maximal exercise test on a treadmill, performed before the start of the interventions. Two protocols will be adopted, with adjustments in density (work-to-recovery ratio) every two weeks. The interventions will last 12 weeks, three times a week, for 60 minutes.', 'interventionNames': ['Other: Aerobic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Pilates plus aerobic', 'description': 'They will perform the same exercises as the Pilates group, however, with 1 set of 10 repetitions, with a 30-second rest between sets and exercises, totaling 30 minutes of intervention per session. In the second half of the intervention period, aerobic exercises will be performed, identical to those of the aerobic group, but for 30 minutes. The interventions will last 12 weeks, three times a week, for 60 minutes.', 'interventionNames': ['Other: Pilates exercises plus aerobic exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will be instructed to maintain their usual routine.'}], 'interventions': [{'name': 'Pilates exercises plus aerobic exercise', 'type': 'OTHER', 'otherNames': ['Pilates', 'aeróbio'], 'description': 'Pilates exercises are characterized as muscle strengthening and stretching, while aerobic exercises are characterized as a modality that works cardiorespiratory fitness.', 'armGroupLabels': ['Pilates plus aerobic']}, {'name': 'Pilates exercises', 'type': 'OTHER', 'otherNames': ['Pilates'], 'description': 'Pilates exercises are characterized as muscle strengthening and stretching.', 'armGroupLabels': ['Pilates']}, {'name': 'Aerobic exercise', 'type': 'OTHER', 'otherNames': ['aerobic'], 'description': 'Aerobic exercises are characterized as a modality that works cardiorespiratory fitness.', 'armGroupLabels': ['Aerobic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86400-000', 'city': 'Jacarezinho', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Universidade Estadual do Norte do Paraná', 'geoPoint': {'lat': -23.16056, 'lon': -49.96944}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'Between 09/01/2025 until the date of publication of the study.', 'ipdSharing': 'YES', 'description': 'Individual participant data will be provided as supplementary material when the study results are published.', 'accessCriteria': 'The information will be freely accessible.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual do Norte do Parana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Raphael Goncalves de Oliveira', 'investigatorAffiliation': 'Universidade Estadual do Norte do Parana'}}}}