Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 1:10 PM
Study NCT ID:
NCT06375356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stronger: Muscle Strengthening for Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of strength exercises the participant logged over the intervention', 'timeFrame': 'Total at the end of 3 months', 'description': 'The total number of strength exercises the participant logs is a measure of adherence to the intervention.'}, {'measure': 'Liking of the intervention', 'timeFrame': '3 month', 'description': 'Liking is measured using a 5-point Likert scale from not at all (1) to extremely (5) at the end of the intervention as a measure of acceptability of the intervention.'}], 'secondaryOutcomes': [{'measure': 'Number of participants completing post 3 month measure / those randomized and consented', 'timeFrame': '3 months', 'description': 'This measures retention rate; this will be a single ratio determined by the denominator of number of participants randomized and consented collected at baseline, and a numerator of the number of participants who complete post 3 month measures'}, {'measure': 'Change in total seconds a participant can remain in a wall sit', 'timeFrame': 'Change from baseline to 3 months', 'description': 'This measures muscular strength endurance. Each participant will be timed using a video- when they initiate and when they stop maintaining a position of sitting at 90 degrees with their back supported by the wall behind them.'}, {'measure': 'Change in number of full body weight squats in 60 seconds', 'timeFrame': 'Change from baseline to 3 months', 'description': 'This measures muscular strength endurance. Each participant will video themselves doing bodyweight squats to reach a chair with a bell on it. Each time they touch the bell will count as a rep.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resistance Training']}, 'descriptionModule': {'briefSummary': 'Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention.', 'detailedDescription': 'Women are at particular risk for low muscle mass as they age, because menopause causes a dramatic reduction in circulating estrogen, which accelerates muscle decline. Preserving muscle is one of the single most important factors to maintaining lifelong independence, with bone, metabolic, cardiovascular, and cognitive health benefits. The most critical behavior for growing and preserving muscle is resistance training, and conservative estimates indicate 4 in 5 US adults do not engage in any resistance training. Commonly cited barriers for women include gender-based stigmas, discouragement, negative comments, poor knowledge of how to do resistance training, poor gym accessibility, and difficulty balancing work and family life. Finally, many menopause practitioners note that with bodyweight as a large concern, many women decrease calorie intake and increase cardiovascular (not resistance) training, further compounding muscle loss. This proposed intervention study aims to develop and pilot a muscle health building intervention with and for menopausal women.\n\nBroadly, the investigators will identify the adherence, feasibility, acceptability, and preliminary changes of a resistance training intervention for menopausal women. The investigators will pilot the 3-month "Stronger" intervention, utilizing a protocol co-designed from focus groups. We will recruit women with menopause and randomize them into one of 2 groups: 1) single-session strength training (Stronger); or 2) "Stronger snacks," the same exercises as the single-session training but broken into single-set snack sizes that are performed throughout the week. The investigators hypothesize that the strength snacks will have the highest adherence and be the most behaviorally accessible and acceptable, but post-study interviews will also help us identify motivational differences.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* one year of no periods or categorized as menopause\n* female at birth\n* English speaking\n\nExclusion Criteria:\n\n* unable to perform strength training movements\n* currently performing regular strength training activities or exercise'}, 'identificationModule': {'nctId': 'NCT06375356', 'briefTitle': 'Stronger: Muscle Strengthening for Menopause', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Stronger: Muscle Strengthening for Menopause', 'orgStudyIdInfo': {'id': '75119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shorter Resistance Training: Stronger Snacks', 'description': 'Home-based strength training exercises would be broken up into shorter segments throughout the day or week (e.g. a "snack" might be 3 sets of body-weight or band-based squats).', 'interventionNames': ['Behavioral: Resistance Training']}, {'type': 'EXPERIMENTAL', 'label': 'Single Session Resistance Training: Stronger Sessions', 'description': 'Home-based strength training exercises would be broken up into 3 weekly sessions throughout the week.', 'interventionNames': ['Behavioral: Resistance Training']}], 'interventions': [{'name': 'Resistance Training', 'type': 'BEHAVIORAL', 'description': 'Strength exercises (3-4 sets each exercise) videos delivered electronically, participant self-tracks and self-progresses based on effort reported.', 'armGroupLabels': ['Shorter Resistance Training: Stronger Snacks', 'Single Session Resistance Training: Stronger Sessions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305-7240', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Instructor of Medicine', 'role': 'CONTACT', 'email': 'moppezzo@stanford.edu', 'phone': '408-314-2629'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'After the primary outcomes of this pilot have been published, deidentified data will be available upon request.', 'ipdSharing': 'YES', 'description': 'IPD will be made available after publication of primary outcomes of the pilot study.', 'accessCriteria': 'proposed use of the data requested is required'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor, Med/Stanford Prevention Research Center', 'investigatorFullName': 'Marily Ann Oppezzo', 'investigatorAffiliation': 'Stanford University'}}}}