Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT06923969
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2025-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Balneotherapy; As a Complementary Way of Maintaining Cardiac Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001452', 'term': 'Balneology'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-04-05', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with spa therapy related cardiac changes as assessed by Echocardiography', 'timeFrame': 'Baseline and 3 weeks.', 'description': 'Recorded parasternal and apical cardiac views in the left decubitus position will be evaluated. Screened parameters will be as follows;\n\n* Left ventricular diastolic diameters (mm)\n* Ejection fraction (%) (Stroke volume / end-diastolic volume) X 100\n* Mitral diastolic velocities (cm/s)\n* Aortic gradient (mmHg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balneotherapy', 'Echocardiography', 'Wellness', 'Heart'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Balneotherapy has been defined as the use of thermal, mineral waters for medical purposes. To highlight its possible effects on cardiac health, echocardiographic parameters were retrospectively analysed before and after the treatment in adult-elderly osteoarthritis patients.', 'detailedDescription': 'Thermal therapies are mostly preferred by adult-elderly patients, and it is highly probable that known or hidden cardiovascular disease prevalences are higher among these patients. Therefore, a cardiovascular examination may be required both before and after the intervention.\n\nTo find out effects of bath therapy on echocardiographic parameters, patients who were consulted to cardiology outpatient clinic before and after the Spa therapy were retrospectively investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '44 patients who were consulted to cardiology outpatient clinic before and after the Spa therapy were retrospectively investigated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criterias:\n\n* Having balneotherapy sessions 5 days a week for total of three weeks\n* Having detailed echocardiography records\n\nExclusion Criterias:\n\n* Individuals who do not have detailed echocardiography records,\n* Having history of major surgery,\n* cerebrovascular accident,\n* malignancy,\n* liver or renal failure,\n* immunodeficiency,\n* acute/chronic infection,\n* psychiatric disorders were exluded.'}, 'identificationModule': {'nctId': 'NCT06923969', 'briefTitle': 'Balneotherapy; As a Complementary Way of Maintaining Cardiac Health', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa City Hospital'}, 'officialTitle': 'Can Balneotherpy be Effective in Prevention and Maintenance of Cardiac Health As a Complementary Intervention in Adult-Elderly Persons', 'orgStudyIdInfo': {'id': '2015-PMR-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'balneotherapy', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16300', 'city': 'Bursa', 'state': 'Nilüfer', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Military Hospital, 1. Murat Caddesi Osmangazi', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Research data will be available upon request from author\n\n(Taner Dandinoglu MD. e-mail: dandinoglu@gmail.com)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Medicine and Rehabilitation (PM&R) physician, MD.', 'investigatorFullName': 'Taner Dandinoğlu', 'investigatorAffiliation': 'Bursa City Hospital'}}}}