Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT02048956
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2014-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrotherapy Intervention in Elderly With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D035061', 'term': 'Control Groups'}], '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'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2014-01-27', 'studyFirstSubmitQcDate': '2014-01-27', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of sleep', 'timeFrame': 'baseline, 8 weeks', 'description': 'Quality of sleep was assessed by Pittsburgh Sleep Quality Index, a self-reported questionnaire.'}], 'primaryOutcomes': [{'measure': 'Changes in pain pressure threshold', 'timeFrame': 'baseline, 8 weeks', 'description': 'The pain pressure threshold is defined as the minimum amount of pressure necessary to induce pain or tenderness . It was measured using a pressure algometer (Somedic AB, Sweden), which is a device with a 1 cm diameter rubber disc at the end on quadriceps muscle.'}], 'secondaryOutcomes': [{'measure': 'Changes in lower extremity strength', 'timeFrame': 'baseline, 8 weeks', 'description': 'Changes in the strength of lower limbs is going to be assessed using the Stairs Climbing Test. This test assesses the ability to ascend and descend a flight of stairs, as well as lower extremity strength, power, and balance.'}, {'measure': 'Dual task', 'timeFrame': 'baseline, 8 weeks', 'description': 'Dual task is going to be measured using the Timed Up \\& Go. It assesses basic mobility skill as well as strength, balance, and agility.'}, {'measure': 'Functional ability', 'timeFrame': 'baseline, 8 weeks', 'description': 'Functional ability was assessed by the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores on the this questionnaire represent greater limitations in function.'}, {'measure': 'Changes in balance', 'timeFrame': 'baseline, 8 weeks', 'description': 'The in balance after the treatment is going to be assessed using the single leg stance. This is a clinical tool that is often used to assess balance and postural steadiness. Subjects are asked to lift one leg off the floor based on their preference and keep the leg raised as long as possible without touching the other leg or the floor'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'hydrotherapy'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks hydrotherapy training with elastic bands on pain and functional disability in old people with knee osteoarthritis.', 'detailedDescription': "The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that a hydrotherapy treatment during 8 weeks would benefit patients with knee osteoarthritis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed clinical diagnosis of knee osteoarthritis\n\nExclusion Criteria:\n\n* total knee arthroplasty\n* inability to co-operate or follow instructions.\n* a major neurological disorder'}, 'identificationModule': {'nctId': 'NCT02048956', 'briefTitle': 'Hydrotherapy Intervention in Elderly With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': '8-weeks Hydrotherapy Intervention in Patients With Knee Osteoarthritis.', 'orgStudyIdInfo': {'id': 'DF0049UG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrotherapy intervention', 'description': '30 people will be recruited in order to the inclusion criteria for the study and they will receive an hydrotherapy intervention.', 'interventionNames': ['Other: Hydrotherapy intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '30 people will be recruited and included in this control group. The are not going to receive hydrotherapy treatment, only the treatment they receive as usual.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Hydrotherapy intervention', 'type': 'OTHER', 'otherNames': ['Exercise program', 'Swimming pool training'], 'description': 'Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.', 'armGroupLabels': ['Hydrotherapy intervention']}, {'name': 'Control group', 'type': 'OTHER', 'otherNames': ['Standard hydrotherapy intervention'], 'description': 'Standard exercises of hydrotherapy', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'state': 'Spain', 'country': 'Spain', 'facility': 'Faculty of health Sciences. University of Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Marie Carmen Valenza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Marie Carmen Valenza', 'investigatorAffiliation': 'Universidad de Granada'}}}}