Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT05932004
Status:
UNKNOWN
Last Update Posted:
2023-07-06
First Post:
2023-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will not informed about the intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demographic information', 'timeFrame': 'Up to one month', 'description': 'Demographic information such as age, height, weight, education level and smoking of all individuals participating in the study will be questioned.'}, {'measure': 'Stroop Test', 'timeFrame': 'Up to one month', 'description': 'The Stroop Test Form will be used to evaluate the cognitive functions of the participants such as attention, reaction inhibition, and information processing.'}, {'measure': 'Right-Left Discrimination', 'timeFrame': 'Up to one month', 'description': 'Motor imaging technique left/right discrimination will be used as cognitive evaluation.'}], 'secondaryOutcomes': [{'measure': 'Assessment of sleep quality and disorder', 'timeFrame': 'Up to one month', 'description': 'The Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality and disorder of the individuals participating in the study in the past month.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Reformer Pilates Exercise, Cognitive Performans']}, 'referencesModule': {'references': [{'pmid': '39593541', 'type': 'DERIVED', 'citation': 'Ozeren A, Ulug N, Sahan N, Can Karahan Z. Does reformer pilates exercise improve cognitive functions in sedentary women? A randomized controlled study. J Bodyw Mov Ther. 2024 Oct;40:1899-1905. doi: 10.1016/j.jbmt.2024.10.031. Epub 2024 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'The reformer is an apparatus on which to perform the foot work and the body in a comfortable, non weight-bearing supine position and keeps the muscles in balance. Studies on Pilates generally include individuals with chronic diseases, geriatric and obese individuals also active women.\n\nThe aim of this study was to investigate the effect of reformer Pilates exercises on cognitive functions in sedentary women', 'detailedDescription': 'A total of 44 sedentary women aged between 24-50 will be randomized into two groups. The reformer Pilates group will receivea 6-week exercise program (45 minutes/twice per week) , while the participants in the control group will be selected from those on the exercise list who will start exercise after the study finishes, but are on a waiting exercise program list. Outcomes measured before and after the interventions are, right/left discrimination and scores of two questionnaires: Stroop Test and The Pittsburgh Sleep Quality Index.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Healthy Sedentary women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 44 sedentary women aged 25-50 years without regular exercise habits\n\nExclusion Criteria:\n\n* Individuals who cannot participate to the exercise program regularly,\n* those with a serious musculoskeletal or neurological history,\n* individuals with communication and emotional problems'}, 'identificationModule': {'nctId': 'NCT05932004', 'briefTitle': 'Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women?', 'organization': {'class': 'OTHER', 'fullName': 'Atılım University'}, 'officialTitle': 'Does Reformer Pilates Exercise Improve Cognitive Functions in Sedentary Women? A Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'E-59394181-604.01.02-22602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Reformer pilates group', 'description': 'Reformer pilates', 'interventionNames': ['Other: Reformer pilates exercise']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'intervention waiting group', 'interventionNames': ['Other: Reformer pilates exercise']}], 'interventions': [{'name': 'Reformer pilates exercise', 'type': 'OTHER', 'description': 'The reformer Pilates group will receivea 6-week exercise program (45 minutes/twice per week) , while the participants in the control group will be selected from those on the exercise list who will start exercise after the study finishes, but are on a waiting exercise program list', 'armGroupLabels': ['Control group', 'Reformer pilates group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atılım University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}