Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
Study NCT ID:
NCT04100850
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2019-09-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006875', 'term': 'Hydrotherapy'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Watsu, Aquatic Exercises, Control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Improvement Perception', 'timeFrame': 'pos (8 week)', 'description': 'Improvement Perception Scale (0-7)'}], 'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'change depression at 8 weeks and follow-up at 12 weeks', 'description': 'Beck Depression Inventory (better 0-63 worse points)'}, {'measure': 'Anxiety', 'timeFrame': 'change anxiety at 8 weeks and follow-up at 12 weeks', 'description': 'Beck Anxiety Inventory (better 0-63 worse points)'}], 'secondaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'change stress at 8 weeks and follow-up at 12 weeks', 'description': 'Depression, Anxiety and Stress Scale (DASS-21) (better 0 - worse \\>34)'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': 'change quality of live at 8 weeks and follow-up at 12 weeks', 'description': '12-Item Short-Form Health Survey (SF-12) (worse 0 - better 100)'}, {'measure': 'Sleep Quality', 'timeFrame': 'change sleep quality at 8 weeks and follow-up at 12 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI) (better 0 - worse 21)'}, {'measure': 'Life Style Scale', 'timeFrame': 'change life style at 8 weeks and follow-up at 12 weeks', 'description': 'Fantastic Life Style Scale (worse 0 - better 100)'}, {'measure': 'Cognitive', 'timeFrame': 'change cognitive at 8 weeks and follow-up at 12 weeks', 'description': 'Montreal Cognitive Assessment (MOCA) (worse 0 - better 30)'}, {'measure': 'Functionally', 'timeFrame': 'change functionally at 8 weeks and follow-up at 12 weeks', 'description': 'Six-minute Walk Test (6m-WT)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hydrotherapy', 'depression', 'anxiety'], 'conditions': ['Depression', 'Depressive Symptoms', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Objective: To compare the effectiveness between aquatic exercises (water aerobics versus Watsu) versus control groups, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression.', 'detailedDescription': 'Introduction: Considered as the "21st century disease", depression is a silent disease that stands out for its high prevalence and high morbidity, leading to serious consequences. With treatments made in aquatic environment, among them the Water aerobics and Watsu. Objective: To compare the effectiveness between aquatic exercises versus Watsu and versus control group, for improving the outcomes of depression, anxiety, stress, sleep quality, functionality, cognition and quality of life in patients with depression. Methods: This study will be a randomized clinical trial, which will last for two months with a follow-up of one month. All participants will be assessed using specific questionnaires for each outcome and an Improvement Perception Scale (MS). Seventy eight (78) patients with a medical diagnosis of depression, aged 18 to 60 years, who will be allocated to three groups (26 patients for each group) will be treated. GROUP 1: Aquatic exercises (aerobic and resistance), collective session, twice a week lasting 50 min; GROUP 2: Watsu (water shiatsu), individual session, twice a week lasting 50 min; Group 3: control, people with depression. Statistical analysis: Normality distribution will be by Shapiro-Wilk test. For comparisons of the means between and within the outcome groups will be used through Generalized Estimation Equations, with its own syntax, linear distribution and, when necessary, multiple comparisons will be performed using the Bonferroni test to identify differences. Will be calculated for comparisons between the final and initial moments and initial follow-up in each group, statistics such as: mean difference (95% CI), standard deviation of the difference, effect size (Cohen\'s d). The statistical significance adopted was 5% and the analyzes were performed using the statistical programs SPSS 22.0 and R 3.2.4. The intention-to-treat analysis will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 60 years old;\n* Sedentary and who have not had physical therapy and physical activity in the last three months;\n* Clinical and cognitive conditions for performing pool activities and moderate aerobic exercise;\n* Who have not undergone high complexity surgical procedures in the last six months; no neuro-musculosqueletal diseases;\n* No contraindications to exercise; such as: urinary and / or fecal incontinence and dermatological diseases;\n* Individuals with a medical diagnosis of depression.\n\nExclusion Criteria:\n\n* If they have up to three absences during the intervention period;\n* If they have any adverse effects, such as: allergy or dermatitis;\n* Unable to continue study due to change of address or hospitalization.'}, 'identificationModule': {'nctId': 'NCT04100850', 'acronym': 'AEforMH', 'briefTitle': 'Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults.', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do vale do São Francisco'}, 'officialTitle': 'Effectiveness of Aquatic Exercises for Improving Mental and Physical Health in Adults: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AE-Mental'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquatic Exercises', 'description': 'Aquatic Exercises (AE) are water aerobics exercises and resistance exercises, classes will be supervised by a Physical Educator, in collective sessions of up to 30 people per class, twice a week, lasting 50 minutes, for two months.', 'interventionNames': ['Other: Aquatic Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Watsu', 'description': 'The Watsu (water shiatsu) will be applied by a physical therapist, in individual sessions, twice a week, lasting 50 minutes, for two months in a warn pool (± 34°C). Watsu in particular prescribes transition of movements, once they are instituted, the therapist can create and adapt according to the limitations and restrictions that are encountered.', 'interventionNames': ['Other: Watsu']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The control group will not receive any of these treatments (aquatic exercises and Watsu).'}], 'interventions': [{'name': 'Aquatic Exercises', 'type': 'OTHER', 'otherNames': ['Aquatic Exercises (AE)'], 'description': 'twice a week, lasting 50 minutes, for two months.', 'armGroupLabels': ['Aquatic Exercises']}, {'name': 'Watsu', 'type': 'OTHER', 'otherNames': ['Water Shiatsu (WS)'], 'description': 'twice a week, lasting 50 minutes, for two months.', 'armGroupLabels': ['Watsu']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56304917', 'city': 'Petrolina', 'state': 'Pernambuco', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Rodrigo GS Carvalho, PhD', 'role': 'CONTACT', 'email': 'rodrigo.carvalho@univasf.edu.br', 'phone': '8721016856'}, {'name': 'Rodrigo GS Carvalho, PhD', 'role': 'CONTACT', 'email': 'rodrigocarvalhofisio@gmail.com', 'phone': '8721016856'}], 'facility': 'Physical Education College', 'geoPoint': {'lat': -9.39861, 'lon': -40.50083}}], 'centralContacts': [{'name': 'Rodrigo GS Carvalho, PhD', 'role': 'CONTACT', 'email': 'rodrigocarvalhofisio@gmail.com', 'phone': '+5587999832015'}, {'name': 'Rodrigo GS Carvalho, Phd', 'role': 'CONTACT', 'email': 'rodrigo.carvalho@univasf.edu.br', 'phone': '+558721016856'}], 'overallOfficials': [{'name': 'Rodrigo GS Carvalho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Physical Education College / UNIVASF'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study Protocol, Randomized Clinical Trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do vale do São Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rodrigo Gustavo da Silva Carvalho', 'investigatorAffiliation': 'Universidade Federal do vale do São Francisco'}}}}