Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-04-14 @ 5:13 AM
Study NCT ID:
NCT03039556
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2017-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Step-reduction in Older Men and Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Sensitivity', 'timeFrame': 'Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)', 'description': 'Assessed via Matsuda ISI'}], 'secondaryOutcomes': [{'measure': 'Change in lean tissue mass', 'timeFrame': 'Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)', 'description': 'Assessed via Dual Energy X-Ray Absorptiometry'}, {'measure': 'Change in Peak Isometric Maximal Voluntary Leg Extension Strength', 'timeFrame': 'Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)', 'description': 'Assessed via muscle dynamometry'}, {'measure': 'Change in Muscle Protein Synthesis', 'timeFrame': 'Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)', 'description': 'Obtained via vastus lateralis muscle biopsy'}]}, 'conditionsModule': {'conditions': ['Older Adults', 'Reduced Physical Activity']}, 'referencesModule': {'references': [{'pmid': '23589526', 'type': 'BACKGROUND', 'citation': 'Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.'}, {'pmid': '26265753', 'type': 'BACKGROUND', 'citation': 'Devries MC, Breen L, Von Allmen M, MacDonald MJ, Moore DR, Offord EA, Horcajada MN, Breuille D, Phillips SM. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015 Aug;3(8):e12493. doi: 10.14814/phy2.12493.'}, {'pmid': '29095970', 'type': 'DERIVED', 'citation': 'McGlory C, von Allmen MT, Stokes T, Morton RW, Hector AJ, Lago BA, Raphenya AR, Smith BK, McArthur AG, Steinberg GR, Baker SK, Phillips SM. Failed Recovery of Glycemic Control and Myofibrillar Protein Synthesis With 2 wk of Physical Inactivity in Overweight, Prediabetic Older Adults. J Gerontol A Biol Sci Med Sci. 2018 Jul 9;73(8):1070-1077. doi: 10.1093/gerona/glx203.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of two weeks of reduced daily ambulation and a subsequent return to normal physical activity on metabolic health of older adults.', 'detailedDescription': 'Aging results in a progressive loss of muscle mass that is accelerated by periods of muscular disuse, common for older adults during hospitalization or convalescence from illness. Transient physical inactivity has been shown to cause muscular atrophy and impairments in insulin sensitivity in both younger and older adults. However, the recovery capacity of older adults after such physical inactivity remains unknown. This study aims to determine the impact of two weeks of daily step reduction to ≤1000 steps per day, an experimental model mimicking short-term physical inactivity, on glycemic control in older adults and further investigate whether older adults are able to recover from the consequences of this inactivity simply by returning to their habitual activity for 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoker\n\nExclusion Criteria:\n\n* Use of assistive walking devices\n* Chronic use of analgesic or anti-inflammatory drugs\n* History of neuromuscular problems or muscle and/or bone wasting disease\n* Acute or chronic illness including cardiac, pulmonary, liver or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders\n* Daily use of statins, particularly simvastatin and atorvastatin\n* Use of medications known to affect protein metabolism\n* Normally complete fewer than 3000 steps per day'}, 'identificationModule': {'nctId': 'NCT03039556', 'acronym': 'CDA-SR', 'briefTitle': 'Step-reduction in Older Men and Women', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'The Influence of Acute Physical Inactivity on Metabolic Function in Older Men and Women', 'orgStudyIdInfo': {'id': '0574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Change in physical activity for older adults', 'description': 'Older adult participants undergo alterations in daily ambulation by completing Normal Daily Steps for one week, followed by a two-week Step-Reduction and a subsequent Return to Normal Daily Steps for two weeks', 'interventionNames': ['Behavioral: Normal Daily Steps', 'Behavioral: Step-Reduction', 'Behavioral: Return to Normal Daily Steps']}], 'interventions': [{'name': 'Normal Daily Steps', 'type': 'BEHAVIORAL', 'description': 'Complete normal daily ambulation for one week', 'armGroupLabels': ['Change in physical activity for older adults']}, {'name': 'Step-Reduction', 'type': 'BEHAVIORAL', 'description': 'Reduce daily ambulation to fewer than 1000 steps per day for two weeks', 'armGroupLabels': ['Change in physical activity for older adults']}, {'name': 'Return to Normal Daily Steps', 'type': 'BEHAVIORAL', 'description': 'Increase daily ambulation to 100% of normal daily step-count for two weeks', 'armGroupLabels': ['Change in physical activity for older adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Exercise Metabolism Research Laboratory, McMaster Univeristy', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stuart Phillips', 'investigatorAffiliation': 'McMaster University'}}}}