Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-03 @ 9:46 PM
Study NCT ID:
NCT02487667
Status:
UNKNOWN
Last Update Posted:
2015-07-01
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Exercise Training in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-29', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-06-29', 'lastUpdatePostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in pain intensity', 'timeFrame': '8 weeks', 'description': 'Measured by Visual Analogue Scale'}, {'measure': 'Change from baseline in range of movement', 'timeFrame': '8 weeks', 'description': 'Measured by a motion capture system'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '8 weeks', 'description': 'weight, BMI'}, {'measure': 'Functional capacity', 'timeFrame': '8 weeks', 'description': 'spirometry and functional tests of the extremities'}, {'measure': 'Quality of life', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Functional Insufficiency', 'Aging']}, 'descriptionModule': {'briefSummary': 'In adulthood, limited mobility and pain are very common and often the first clear sign of functional decline. The loss of independent mobility is related to higher rates of functional disability and mortality; however, it is also susceptible to interventions through exercises. With aging, changes in peripheral and central nervous system also occur, which lead to degradation of the sensory receptors as well as a loss of muscle mass and coordination. However, both, structural and functional dysfunctions of the nervous system, can be mitigated by increasing physical activity.\n\nThe aim of this study is therefore, to study the effects on pain and functional capacity of a therapeutic exercise training program in an adult people sample. The therapeutic exercise machines proposed in this trial have not been previously analyzed and provide insight into this field due to their design. The design of this new machines allows the adaptation to each concrete clinical situation by the adjustment of different parameters such as feedback, range of movement, time of repetition, intensity, speed and rhythm, which facilitate motor control training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to complete self-reported questionnaires\n* Autonomous ambulation that allows the realization of functional test\n* Accept and consent to voluntarily participate in the study\n* Preclinical mobility restriction and/or pain in absence of important pathologies.\n\nExclusion Criteria:\n\n* Present contraindications for physical exercise\n* Receiving physiotherapy treatment during the time of the trial.\n* Modification of physical habits\n* Change the pattern or usual pharmacotherapy'}, 'identificationModule': {'nctId': 'NCT02487667', 'briefTitle': 'Therapeutic Exercise Training in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Effects of a Therapeutic Exercise Program by a Feedback a Motor Control System in the Elderly', 'orgStudyIdInfo': {'id': 'A14/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'Therapeutic exercise', 'interventionNames': ['Device: Therapeutic exercise by fitness machines']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'No treatment'}], 'interventions': [{'name': 'Therapeutic exercise by fitness machines', 'type': 'DEVICE', 'description': 'Therapeutic exercise program by using 8 exercise machine circuit', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alazne Ruiz de Escudero Zapico', 'role': 'CONTACT', 'email': 'alazne@unizar.es', 'phone': '615007759'}], 'facility': 'Alazne Ruiz de Escudero Zapico', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Alazne Ruiz de Escudero Zapico', 'role': 'CONTACT', 'email': 'alazne@unizar.es', 'phone': '615007759'}], 'overallOfficials': [{'name': 'Alazne Ruiz de Escudero Zapico', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidad de Investigacion en Fisioterapia. Universida de Zaragoza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Alazne Ruiz de Escudero Zapico', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}