Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT03952104
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2019-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strength Training and Quality of Life in Elderly
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome Assessor Blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life, assessed through the Short Form 36 health survey questionnaire.', 'timeFrame': '32 weeks', 'description': 'This questionnaire measures quality of live. It provides information on 8 scales, scoring from 0 (worst health) to 100 (best health), and on the physical component scale (PCS) and the mental component scale (MCS), normalized scores representing overall physical and mental functioning.'}], 'secondaryOutcomes': [{'measure': 'Emotional wellbeing, assessed through the STAI (State-Trait Anxiety Inventory) questionnaire.', 'timeFrame': '32 weeks', 'description': 'The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, \\& Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress. STAI has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.'}, {'measure': 'Motivation towards physical activity, assessed through the Behavioural Regulation in Exercise Questionnaire (BREQ-2)', 'timeFrame': '32 weeks', 'description': 'This questionnaire consists of 19 items measuring stages on the continuum of self-determination. It measures external regulation (4 items), introjected regulation (3 items), identified regulation (4 items), intrinsic regulation (4 items), and it adds amotivation (4 items) on a scale from 1 (Not at all true for me) to 5 (Absolutely true for me). Each of the subscales has a maximum score, with a maximum of 20 for external regulation, identified regulation, intrinsic regulation and amotivation, and 15 for introjected regulation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': 'Aim: To evaluate the impact of three different strength training programs on psychological wellbeing of elderly.', 'detailedDescription': 'Background: Physical activity in the elderly has benefits which improve psychological wellbeing. However, the majority of older adults perform less physical activity with advancing age.\n\nAim: To evaluate the impact of three different 32-week strength training programs (low, moderate and high intensity) on psychological wellbeing of elderly.\n\nDesign: Randomized Controlled Trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥60 years;\n* having the ability to speak and write in Spanish;\n* having the ability to complete the questionnaires independently.\n\nExclusion Criteria:\n\n-the presence of any medical problem or pathology that could hinder physical activity practice'}, 'identificationModule': {'nctId': 'NCT03952104', 'acronym': 'ST-QOL', 'briefTitle': 'Strength Training and Quality of Life in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Effects of Different Strength Training Programs on Quality of Life in Elderly', 'orgStudyIdInfo': {'id': 'UNIVERSITY CARDENAL HERRERA-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental-Low Intensity Strength Training', 'description': 'Strength training (low intensity)', 'interventionNames': ['Other: Strength training']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental-Moderate Intensity Strength Training', 'description': 'Strength training (moderate intensity)', 'interventionNames': ['Other: Strength training']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental-High Intensity Strength Training', 'description': 'Strength training (high intensity)', 'interventionNames': ['Other: Strength training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'Strength training', 'type': 'OTHER', 'description': 'Strength training', 'armGroupLabels': ['Experimental-High Intensity Strength Training', 'Experimental-Low Intensity Strength Training', 'Experimental-Moderate Intensity Strength Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46113', 'city': 'Moncada', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Universidad CEU Cardenal Herrera', 'geoPoint': {'lat': 39.54555, 'lon': -0.39551}}], 'overallOfficials': [{'name': 'JF Lisón, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardenal Herrera University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Medicine', 'investigatorFullName': 'Juan F. Lisón Párraga, Dr', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}