Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-31 @ 12:39 PM
Study NCT ID:
NCT06977958
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-18
First Post:
2025-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NASM OPT for Gluteal Enhancement in Non-Athletic Women: An RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2025-05-10', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gluteal Strength', 'timeFrame': 'Baseline, 12 weeks (post-intervention)', 'description': 'kg; handheld dynamometer'}, {'measure': 'Perceived Hip Shape/Lift', 'timeFrame': 'Baseline, 12 weeks (post-intervention)', 'description': '5-point Likert scale'}, {'measure': 'Hip Circumference', 'timeFrame': 'Baseline, 12 weeks (post-intervention)', 'description': 'cm'}], 'secondaryOutcomes': [{'measure': 'Aesthetic Satisfaction', 'timeFrame': 'Baseline, 12 weeks', 'description': '5-point Likert scale'}, {'measure': 'Functional Performance', 'timeFrame': 'Baseline, 12 weeks', 'description': '30-second squat test'}, {'measure': 'Low Back Pain', 'timeFrame': 'Baseline, 12 weeks', 'description': 'VAS, 0-10 cm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NASM OPT', 'Gluteal Muscles', 'Hip Aesthetics', 'Non-Athletic Women', 'Resistance Training'], 'conditions': ['Low Back Pain', 'Muscle Weakness', 'Body Image Disturbance']}, 'descriptionModule': {'briefSummary': 'This RCT evaluates a 12-week NASM OPT program targeting gluteal muscle strength, hip aesthetics (shape, lift, circumference), and low back pain in 120 non-athletic women. The intervention group performed structured resistance training, while the control group engaged in general exercise. Outcomes included gluteal strength (dynamometer), aesthetic satisfaction (Likert scale), and functional performance (squat test).', 'detailedDescription': 'Participants were randomized to NASM OPT (3 weekly sessions: stabilization, strength, and hypertrophy phases) or general exercise (brisk walking/aerobics). Measurements at baseline and 12 weeks included gluteal strength, hip circumference, low back pain (VAS), and perceived aesthetics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-athletic women (no exercise in prior 6 months).\n* Interest in improving hip aesthetics.\n* No musculoskeletal injuries.\n\nExclusion Criteria:\n\n* Pregnancy\n* Chronic illness\n* Exercise contraindications'}, 'identificationModule': {'nctId': 'NCT06977958', 'acronym': 'GlutealEnhan', 'briefTitle': 'NASM OPT for Gluteal Enhancement in Non-Athletic Women: An RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of Sistan and Baluchestan'}, 'officialTitle': 'Efficacy of a 12-Week NASM Optimum Performance Training Program on Gluteal Muscle Strength, Hip Aesthetics, and Low Back Pain in Non-Athletic Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '9378-30-2-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NASM OPT Group', 'description': 'Behavioral: NASM OPT Program Three 60-minute weekly sessions for 12 weeks, progressing through stabilization (weeks 1-4), strength endurance (weeks 5-8), and hypertrophy (weeks 9-12) phases. Exercises included hip thrusts, squats, and glute bridges.', 'interventionNames': ['Behavioral: NASM OPT Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General Exercise Group', 'description': 'Behavioral: General Exercise Three 60-minute weekly sessions of brisk walking and light aerobics without targeted resistance training.', 'interventionNames': ['Behavioral: General Exercise Group']}], 'interventions': [{'name': 'NASM OPT Group', 'type': 'BEHAVIORAL', 'description': 'Three 60-minute weekly sessions for 12 weeks, progressing through stabilization (weeks 1-4), strength endurance (weeks 5-8), and hypertrophy (weeks 9-12) phases. Exercises included hip thrusts, squats, and glute bridges.', 'armGroupLabels': ['NASM OPT Group']}, {'name': 'General Exercise Group', 'type': 'BEHAVIORAL', 'description': 'Three 60-minute weekly sessions of brisk walking and light aerobics without targeted resistance training.', 'armGroupLabels': ['General Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ferdows', 'state': 'South Khorasan Province', 'country': 'Iran', 'facility': 'Ferdows Shafa Center', 'geoPoint': {'lat': 34.0185, 'lon': 58.17222}}], 'overallOfficials': [{'name': 'Mohammadreza Rezaeipour, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Privacy concerns regarding sensitive participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sistan and Baluchestan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.Dr. of Sports Sciences', 'investigatorFullName': 'Mohammadreza Rezaeipour', 'investigatorAffiliation': 'University of Sistan and Baluchestan'}}}}