Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:29 AM
Study NCT ID:
NCT07429604
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pilates on Body Awareness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Awareness', 'timeFrame': 'Baseline (Week 0): All outcome measures will be assessed prior to the start of the intervention. Post-intervention (Week 8): All outcome measures will be reassessed immediately after completion of the 8-week program.', 'description': "Body awareness will be assessed using the Body Awareness Questionnaire. The scale evaluates individuals' sensitivity to normal and abnormal bodily processes and awareness of physical sensations. Scores range across items rated on a Likert scale, with higher total scores indicating greater body awareness. Measurements will be collected at baseline and after the 8-week intervention period."}], 'secondaryOutcomes': [{'measure': 'Postural Alignment', 'timeFrame': 'Baseline (Week 0): All outcome measures will be assessed prior to the start of the intervention. Post-intervention (Week 8): All outcome measures will be reassessed immediately after completion of the 8-week program.', 'description': 'Posture will be evaluated using the New York Posture Rating Test, which assesses postural alignment across multiple body segments. Higher scores indicate better postural alignment. Measurements will be obtained at baseline and after the 8-week intervention period.'}, {'measure': 'Flexibility', 'timeFrame': 'Baseline (Week 0): All outcome measures will be assessed prior to the start of the intervention. Post-intervention (Week 8): All outcome measures will be reassessed immediately after completion of the 8-week program.', 'description': 'Flexibility of the lower back and hamstring muscles will be assessed using the Sit-and-Reach Test. The best score from three attempts will be recorded. Measurements will be collected at baseline and after the 8-week intervention period.'}, {'measure': 'Life Satisfaction', 'timeFrame': 'Baseline (Week 0): All outcome measures will be assessed prior to the start of the intervention. Post-intervention (Week 8): All outcome measures will be reassessed immediately after completion of the 8-week program.', 'description': "Life satisfaction will be assessed using a self-reported satisfaction evaluation form examining participants' perceived satisfaction with physical appearance, psychological well-being, and daily life. Measurements will be collected at baseline and after the 8-week intervention period."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Body Awareness', 'Flexibility', 'Life Satisfaction']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of an 8-week mat Pilates exercise program on body awareness, posture, flexibility, and life satisfaction in healthy women aged 30-50 years. A total of 38 sedentary women will be allocated into a Pilates exercise group or a control group. The intervention group will participate in supervised Pilates sessions twice weekly, while the control group will maintain their usual lifestyle without structured exercise. Outcomes will be assessed at baseline and after the intervention using validated measures of body awareness, postural alignment, flexibility, and self-reported satisfaction. The findings of this study are expected to clarify the potential benefits of Pilates exercise in improving physical and psychosocial well-being in healthy adult women.', 'detailedDescription': "Body awareness refers to an individual's ability to perceive bodily position, movement, and internal sensations, and it plays an essential role in motor control, posture regulation, and emotional self-regulation. Higher levels of body awareness are associated with improved coordination, breathing control, and adaptive responses to physical changes. Posture, defined as the balanced alignment of body segments, is critical for minimizing musculoskeletal strain, preventing fatigue, and maintaining efficient movement patterns. Flexibility, another key component of physical fitness, allows joints to move through their full range of motion and is associated with functional independence and reduced injury risk. In addition to these physical parameters, life satisfaction represents an important psychosocial outcome reflecting an individual's overall evaluation of well-being.\n\nThe Pilates method, originally developed by Joseph Pilates, is a mind-body exercise approach emphasizing controlled movement, breathing, core stability, and postural alignment. Previous studies have demonstrated that Pilates training may improve flexibility, posture, and psychological well-being in various populations. However, evidence specifically examining its combined effects on body awareness, posture, flexibility, and life satisfaction in healthy middle-aged women remains limited.\n\nThe present study is designed as a controlled clinical trial including sedentary women aged 30-50 years. Participants will be allocated to either a Pilates intervention group or a non-exercise control group. The intervention group will complete an 8-week supervised mat Pilates program conducted twice weekly, consisting of warm-up exercises, breathing training, Pilates-based strengthening and control exercises, and cool-down activities. The control group will continue their normal daily activities without structured exercise during the study period.\n\nOutcome measures will be collected at baseline and after the 8-week period using validated assessment tools evaluating body awareness, postural alignment, flexibility, and self-reported satisfaction. The primary aim is to determine whether regular Pilates exercise improves physical and psychosocial parameters compared with a non-exercise condition. The results are expected to contribute to the evidence base regarding the role of structured mind-body exercise in promoting health and well-being among adult women."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'This study will include only female participants, as the research aims to investigate the effects of Pilates exercise on body awareness, posture, flexibility, and life satisfaction specifically in healthy adult women aged 30-50 years. Restricting the sample to women ensures a more homogeneous study population and improves the interpretability of the findings for this target group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants aged 30-50 years\n* Body mass index (BMI) below 30 kg/m²\n* No regular structured exercise participation within the past 2 years\n* Able to read and understand the questionnaires\n* Willing to participate and provide informed consent\n\nExclusion Criteria:\n\n* Presence of musculoskeletal pain or injury\n* History of regular exercise within the past 2 years\n* BMI ≥ 30 kg/m²\n* History of major surgery affecting mobility or posture\n* Pregnancy or menopause\n* Inability or unwillingness to complete questionnaires\n* Any medical or physical condition preventing safe participation in exercise'}, 'identificationModule': {'nctId': 'NCT07429604', 'briefTitle': 'Effects of Pilates on Body Awareness', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Investigation of the Effects of Pilates on Body Awareness, Posture, Flexibility, and Satisfaction', 'orgStudyIdInfo': {'id': 'Seda Pilates'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates Exercise Group', 'description': 'Participants in this group will attend a supervised mat Pilates exercise program for 8 weeks, conducted twice weekly for 60 minutes per session. Each session will include warm-up exercises, breathing training, Pilates-based strengthening and control exercises, and cool-down activities. All sessions will be led by a physiotherapist.', 'interventionNames': ['Other: Pilates Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group will not receive any structured exercise intervention during the 8-week study period and will be instructed to maintain their usual daily routines.'}], 'interventions': [{'name': 'Pilates Exercise', 'type': 'OTHER', 'description': 'The intervention consists of a supervised mat-based Pilates exercise program developed according to the principles of the method introduced by Joseph Pilates. The program will be conducted for 8 weeks, with sessions held twice weekly, each lasting approximately 60 minutes.\n\nEach session will include three phases:\n\nWarm-up phase (10-20 minutes): light mobility exercises and breathing control exercises to prepare the body for movement.\n\nMain exercise phase (approximately 30 minutes): mat-based Pilates exercises focusing on core stabilization, postural control, flexibility, coordination, and controlled movement patterns. Exercises will be progressively adapted to participant tolerance and performance.\n\nCool-down phase (approximately 10 minutes): stretching, relaxation, and breathing exercises.\n\nAll sessions will be delivered in small groups and supervised by a licensed physiotherapist experienced in Pilates-based rehabilitation to ensure correct technique and participant safety.', 'armGroupLabels': ['Pilates Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Fizyosağlık Fizyoterapi ve Danışmanlık Merkezi', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}, {'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Fatih Tekin', 'role': 'STUDY_CHAIR', 'affiliation': 'Assoc. Prof.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Fatih Tekin', 'investigatorAffiliation': 'Pamukkale University'}}}}