Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-04 @ 3:57 AM
Study NCT ID:
NCT03308292
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2017-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of an Exercise Program on Bone Density
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2017-10-07', 'studyFirstSubmitQcDate': '2017-10-07', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in bone density', 'timeFrame': '3 months', 'description': 'Change from baseline to 3 months using Dual-energy X-ray Absorptiometry'}, {'measure': 'Changes in body composition', 'timeFrame': '3 months', 'description': 'Change from baseline to 3 months using Dual-energy X-ray Absorptiometry'}], 'secondaryOutcomes': [{'measure': 'Level of compliance with the exercise program', 'timeFrame': '3 months', 'description': 'Level of compliance with the program using the percentage of compliance to the exercise programme (36 sessions)'}, {'measure': 'Changes in Dietary pattern variables: macronutrients', 'timeFrame': '3 months', 'description': 'Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries'}, {'measure': 'Changes in Dietary pattern variables: quality of diet', 'timeFrame': '3 months', 'description': 'Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Density', 'Body Composition']}, 'referencesModule': {'references': [{'pmid': '31638477', 'type': 'DERIVED', 'citation': 'Iturriaga T, Barcelo O, Diez-Vega I, Cordero J, Pulgar S, Fernandez-Luna A, Perez-Ruiz M. Effects of a short workplace exercise program on body composition in women: A randomized controlled trial. Health Care Women Int. 2020 Feb;41(2):133-146. doi: 10.1080/07399332.2019.1679813. Epub 2019 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'Physical inactivity and low adherence to the Mediterranean diet cause alterations in body composition, which increases the risk factors for cardiovascular and metabolic diseases. In addition, exercise in different surfaces or water could affect the bone density specially in women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic exercise program in different surfaces on the body composition and bone density of women within at work, and to evaluate the quality of the Mediterranean diet and distribution of macronutrients in the studied population. Material \\& Methods: Randomized controlled trial. 63 women from a randomized work environment (IG, n=34) and a control group (CG, n=29) participated in a short-term aerobic exercise programmed (12 weeks), for body composition and bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for macronutrient distribution were used.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not diagnosed with any disease that contraindicates the practice of physical exercise\n* Do not perform physical activity with continuity\n\nExclusion Criteria:\n\n* Diagnosed with chronic disease including cardiovascular and respiratory diseases that contraindicate the practice of physical exercise\n* Being pregnant before or during the intervention (for intervention and control group)'}, 'identificationModule': {'nctId': 'NCT03308292', 'briefTitle': 'Effects of an Exercise Program on Bone Density', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Effects of Exercise in Different Sport Surfaces, Diet and Lifestyle in the Bone Density of Pre and Post Menopausal Women', 'orgStudyIdInfo': {'id': 'P2016/UEM33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'A moderate-intensity aerobic physical exercise programme was carried out during the months of March to May 2017 (12 weeks), with a frequency of three sessions per week (36 sessions in total) with a duration of 45 minutes per session. The intensity was controlled through the Borg 1982 modified scale of perceived exertion (RPE). It is a scale from 0 to 10, considering 0 as "nothing at all" and 10 as "very very strong", setting the moderate intensity as value', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Aerobic exercise program', 'armGroupLabels': ['Intervention Group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ÁLVARO FERNÁNDEZ LUNA', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}