Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-25 @ 6:51 PM
Study NCT ID:
NCT04169620
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088543', 'term': 'Aquatic Therapy'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessed with VAS scale', 'timeFrame': 'ten weeks', 'description': 'VAS scale'}], 'secondaryOutcomes': [{'measure': 'Balance assessed with Berg Balance scale', 'timeFrame': 'ten weeks', 'description': 'Berg Balance scale'}, {'measure': 'Functionality assessed with UPDRS scale', 'timeFrame': 'ten weeks', 'description': 'UPDRS scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Physical Disability']}, 'descriptionModule': {'briefSummary': "The aim of this study is to determine the effect of an aquatic Ai Chi training program on the perception of pain, the maintenance of balance and the functional independence of patients with Parkinson's disease.\n\nFifteen patients diagnosed with Parkinson's disease (Hoehn and Yahr range: 1-3) participated in a program of Aquatic Ai Chi lasting ten weeks with sessions held twice weekly. These were compared to a group of 15 Parkinson patients (control group) who received therapy on dry land.", 'detailedDescription': 'All study participants met the following inclusion criteria: individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation). The exclusion criteria were: individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait.\n\nThe procedure of randomization was performed for the overall sample using stratified randomization controlling for the Hoehn \\& Yahr stage employing Excell software (Microsoft Excell 2013: Microsoft Corp. Redmond WA).\n\nThe participants received an initial assessment on dry land lasting 30-45 minutes, performed by a physiotherapist not involved in the study. Timetable norms were disclosed as well as recommendations regarding appropriate clothing for the activity. A baseline assessment was performed prior to commencing therapy. This was repeated upon completion of all sessions while a follow-up assessment took place one month later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation).\n\nExclusion Criteria:\n\n* individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait.'}, 'identificationModule': {'nctId': 'NCT04169620', 'briefTitle': "Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial", 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Almeria'}, 'officialTitle': "Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial", 'orgStudyIdInfo': {'id': 'spd205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'variable aquatic Ai Chi', 'description': 'The 15 patients assigned to the aquatic therapy group (experimental group) received 20 twice-weekly sessions in total, during the same period of time as the control group. These 20 sessions consisted of group sessions lasting 45-minutes.\n\nThe sessions were designed with a gradual increase in difficulty. Initially, a recreational warm-up activity was performed, followed by 30 minutes dedicated to practicing the Ai Chi Program. At the end of the session there was a calming down activity. The exercises were performed in a specific order, until completion of the 19 possible movements.', 'interventionNames': ['Other: aquatic Ai Chi']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'variable dry land', 'description': 'These sessions consisted of group sessions of supervised training lasting 45 minutes each. These comprised a 10-minute warm-up that included exercises for gait, trunk mobility and exercises involving the upper and lower limbs. The central part of the sessions consisted of 30-40 minutes of strength training and aerobic exercises, both individual and in groups. Each session was performed with a specific intensity goal, in order to end with a cooling down period, comprising 20 minutes of functional exercises based on activities of daily living, balance exercises, facial muscle exercises, proprioceptive exercises, muscle relaxation and stretching.', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'aquatic Ai Chi', 'type': 'OTHER', 'description': 'The sessions took place in a pool measuring 20 m x 6 m, at a depth of 110 cm. The water temperature was 30oC (with variations of less than 0.5o) and the room temperature was 27.5oC (with variations of less than 1o). The proportions of the pool were ideally suited for collective treatment.\n\nThe sessions were designed with a gradual increase in difficulty. Initially, a recreational warm-up activity was performed, followed by 30 minutes dedicated to practicing the Ai Chi Program. At the end of the session there was a calming down activity. The exercises were performed in a specific order, until completion of the 19 possible movements.', 'armGroupLabels': ['variable aquatic Ai Chi']}, {'name': 'control', 'type': 'OTHER', 'description': 'These sessions consisted of group sessions of supervised training lasting 45 minutes each. These comprised a 10-minute warm-up that included exercises for gait, trunk mobility and exercises involving the upper and lower limbs. The central part of the sessions consisted of 30-40 minutes of strength training and aerobic exercises, both individual and in groups. Each session was performed with a specific intensity goal, in order to end with a cooling down period, comprising 20 minutes of functional exercises based on activities of daily living, balance exercises, facial muscle exercises, proprioceptive exercises, muscle relaxation and stretching.', 'armGroupLabels': ['variable dry land']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04120', 'city': 'La Cañada de San Urbano', 'state': 'Almería', 'country': 'Spain', 'facility': 'University of Almería', 'geoPoint': {'lat': 36.8402, 'lon': -2.40601}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Almeria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'SAGRARIO PÉREZ DE LA CRUZ', 'investigatorAffiliation': 'Universidad de Almeria'}}}}