Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT06409858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Testing of Les Mills Pilates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-08-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core endurance (time to failure in seconds)', 'timeFrame': '8 weeks', 'description': 'Endurance of the core muscles- abdominals, back extensors, hip extensors, quadriceps- time to hold a plank (abdominals), biering-sorenson test (back extensors), unilateral hip bridge (hip extensors), wall sit (quadriceps) will be recorded. Participants will hold each position until failure. Higher times to reach failure indicate more endurance (better value).'}], 'secondaryOutcomes': [{'measure': 'Balance (single leg reach distance in cm)', 'timeFrame': '8 weeks', 'description': 'Y-balance test- distance in cm. Higher distances are better outcomes.'}, {'measure': 'Core stability: Sahrmann trunk stability test', 'timeFrame': '8 weeks', 'description': 'Sahrmann trunk stability test- maximum level participants can perform with neutral lumbar spine. Level 1 (minimum value) to Level 5 (maximum value). Higher scores are better outcome.'}, {'measure': 'Flexibility in cm', 'timeFrame': '8 weeks', 'description': 'Forward reach test. Participants sit with legs extended and reach forward as far as they can. Reach distance is measured. Higher scores are better outcome (more flexibility).'}, {'measure': 'Mood', 'timeFrame': 'Daily for 8 weeks', 'description': 'Perceived motivation, stress and fatigue on 0 (minimum value) -5 (maximum value) Likert scale, where higher numbers indicate more motivation (better outcome), stress (worst outcome), or fatigue (worse outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Core Muscle Endurance']}, 'descriptionModule': {'briefSummary': 'Objectives: Determine the effect of an 8-week intervention of the new group fitness program Les Mills Pilates on balance, core stability, abdominal, back, and hip muscle endurance, flexibility, and mood. Research questions: Does doing Les Mills Pilates twice per week for 8 weeks result in: 1) increased balance, 2) increased core stability, 3) increased abdominal, back, and hip muscle endurance, 4) increased flexibility, and 5) improved mood? Intended outcomes: this study will determine the efficacy of a new group fitness program developed by Les Mills International. Results will be used to help refine the program, as well as in marketing of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not participating in regular core training (no more than 10 minutes per session, twice per week)\n* Active (150 minutes per week of moderate to vigorous physical activity)\n\nExclusion Criteria:\n\n* any neurological, cardiovascular, or musculoskeletal conditions that would put them at risk while participating, or be made worse by exercise\n* Participants with current lower back pain\n* Pregnant participants'}, 'identificationModule': {'nctId': 'NCT06409858', 'briefTitle': 'Efficacy Testing of Les Mills Pilates', 'organization': {'class': 'OTHER', 'fullName': 'University of the Fraser Valley'}, 'officialTitle': 'Efficacy Testing of Les Mills Pilates', 'orgStudyIdInfo': {'id': '101548'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'All participants will receive twice weekly Pilates classes for 8 weeks', 'interventionNames': ['Other: Pilates']}], 'interventions': [{'name': 'Pilates', 'type': 'OTHER', 'description': 'Twice-weekly mat Pilates class for 8 weeks, either in person or online (depending on participant availability)', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gillian L Hatfield, PhD', 'role': 'CONTACT', 'email': 'gillian.hatfield@ufv.ca', 'phone': '604-504-7441', 'phoneExt': '2217'}], 'overallOfficials': [{'name': 'Gillian L Hatfield, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Fraser Valley'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Fraser Valley', 'class': 'OTHER'}, 'collaborators': [{'name': 'Les Mills International', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gillian Hatfield', 'investigatorAffiliation': 'University of the Fraser Valley'}}}}