Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-04 @ 7:52 PM
Study NCT ID:
NCT05397418
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Female Muscle Enhancement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm parallel unblinded randomised design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sustainability of the exercise program through monitoring class attendance when unsupervised.', 'timeFrame': '12 weeks', 'description': 'Suitability of the exercise program as a sustainable form of unsupervised online exercise as recorded in participant exercise diaries.'}], 'primaryOutcomes': [{'measure': 'Muscle function', 'timeFrame': '12 weeks', 'description': 'Peak torque (Nm) of the shoulder and hip'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '12 weeks', 'description': 'Changes in fat mass and lean body mass'}, {'measure': 'Bone mineral density', 'timeFrame': '12 weeks', 'description': 'Changes in bone mineral density'}, {'measure': 'Muscle thickness', 'timeFrame': '12 weeks', 'description': 'Changes in muscle thickness'}, {'measure': 'Muscle protein synthesis', 'timeFrame': '12 weeks', 'description': 'Rate of muscle protein synthesis'}, {'measure': 'Energy expenditure', 'timeFrame': '12 weeks', 'description': 'Changes in energy expenditure rates'}, {'measure': 'Sleep Quality', 'timeFrame': '12 weeks', 'description': 'Changes in sleep quality using the Pittsburgh sleep quality index (PSQI) questionnaire'}, {'measure': 'Self reported quality of life', 'timeFrame': '12 weeks', 'description': 'Changes in self reported wellbeing measures using the Short Form Survey (SF-36)'}, {'measure': 'Physical activity levels', 'timeFrame': '12 weeks', 'description': 'Changes in physical activity energy expenditure as measured using an accelerometer'}, {'measure': 'Exercise program acceptability', 'timeFrame': '12 weeks', 'description': 'Changes in the rating of enjoyment of leisure time activity using the Groningen Enjoyment Questionnaire to rate enjoyment of exercise on a scale from strongly disagree to strongly agree'}, {'measure': 'Changes in balance', 'timeFrame': '12 weeks', 'description': 'Balance measured using the Y-balance test'}, {'measure': 'Changes in flexibility', 'timeFrame': '12 weeks', 'description': 'Flexibility measured using distance (cm) in zipper and sit and reach test'}, {'measure': 'Changes in cardiovascular risk markers', 'timeFrame': '12 weeks', 'description': 'Changes in biochemical lipid profile'}, {'measure': 'Changes in diabetes risk markers', 'timeFrame': '12 weeks', 'description': 'Changes in biochemical measures of HbA1c'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle function', 'Females', 'Resistance exercise'], 'conditions': ['Muscle Function']}, 'referencesModule': {'references': [{'pmid': '39480197', 'type': 'DERIVED', 'citation': 'Svensen E, Koscien CP, Alamdari N, Wall BT, Stephens FB. A Novel Low-Impact Resistance Exercise Program Increases Strength and Balance in Females Irrespective of Menopause Status. Med Sci Sports Exerc. 2025 Mar 1;57(3):501-513. doi: 10.1249/MSS.0000000000003586. Epub 2024 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'Participating in regular physical activity has been shown to reduce the risk of developing some diseases and disabilities that can occur with ageing. Muscles naturally decline with age, and in females this appears to occur more so around the time of menopause. Time, work, family commitments and the availability of facilities have all been identified as barriers to exercise in middle age.\n\nIncreasing activity levels in middle age appears to improve muscle function and bone health. However, there is a lack of evidence in how muscle function responds to low impact resistance exercise in middle aged females.\n\nThis study aims to assess the effectiveness and the mechanisms associated with building muscle as well as the effect on quality of life in middle aged (40-60 years) females using a low impact resistance training programme.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females aged 40-60 years of age at time of screening.\n* Body mass index \\<30kg/m2 and \\>18.5kg/m2\n* Considered moderately active according to the 7 day International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)\n* Self-reported as healthy (absence of injury or disease).\n* Availability and willingness to attended 12 weeks of exercises classes 4-5 times per week at St Luke's Campus Exeter and participate in the study lasting a total of 26 weeks.\n\nExclusion Criteria:\n\n* Pregnant, lactating or planning a pregnancy.\n* Current diagnosis of a chronic disease such as diabetes, autoimmune disease, cardiovascular disease, kidney disease.\n* Hysterectomy and/or ovariectomy.\n* Currently prescribed hormone replacement therapy.\n* Hypertension (BP ≥149/90 mm/Hg)\n* Either current smoker, or history of smoking in the past 6 months.\n* Currently taking supplements that have been shown to impact muscle function and muscle mass, such as creatine, in the last 6 months.\n* Prescribed medications that have been shown to impact muscle function and muscle mass, such as steroids, in the last 6 months.\n* History of epilepsy.\n* Current or recent injury within the last 6 months that may affect their ability to carry out the resistance training program.\n* Advised not to exercise by their General Practitioner or medical professional.\n* Resistance training consistently for 3 or more times per week for the last 2 months"}, 'identificationModule': {'nctId': 'NCT05397418', 'acronym': 'FemME', 'briefTitle': 'Female Muscle Enhancement', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Effectiveness of a 12-week Low Impact Resistance Training Programme on Muscle Function, Body Composition, Quality of Life and Muscle Protein Synthesis in Women Aged 40-60 Years', 'orgStudyIdInfo': {'id': '2021-22-13'}, 'secondaryIdInfos': [{'id': '309199', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Supervised exercise program week 1-12, unsupervised exercise week 13-24.', 'interventionNames': ['Behavioral: Supervised resistance exercise program', 'Behavioral: Unsupervised resistance exercise program']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Maintain habitual activity week 1-12, unsupervised exercise week 13-24.', 'interventionNames': ['Behavioral: Unsupervised resistance exercise program']}], 'interventions': [{'name': 'Supervised resistance exercise program', 'type': 'BEHAVIORAL', 'description': '12 week supervised low impact resistance training program', 'armGroupLabels': ['Intervention group']}, {'name': 'Unsupervised resistance exercise program', 'type': 'BEHAVIORAL', 'description': '12 week unsupervised low impact resistance training program', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX1 2LT', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'University of Exeter', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}], 'overallOfficials': [{'name': 'Francis Stephens', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'collaborators': [{'name': 'P.volve LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}