Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT06264102
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2024-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Dalcroze Eurhythmics on Pains in Older Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain levels before exercise program', 'timeFrame': 'From enrollment to the day before the start of the exercise program', 'description': 'Level of pains determined by numeric pain scale 1-10'}], 'secondaryOutcomes': [{'measure': 'Results of pain levels after exercise program', 'timeFrame': 'One month after completion of the exercise program', 'description': 'Level of pains determined by numeric pain scale 1-10'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['headache', 'elderly women', 'Dalcroze Eurhythmics', 'back pain', 'leg pain'], 'conditions': ['Back Pain', 'Headache', 'Leg Pain']}, 'descriptionModule': {'briefSummary': 'In this study, we attempted to answer the question of whether participation in a 12-week rhythmic exercise program using the Dalcroze method affects the level of intensity of pain experienced by women over the age of 65. The level of pain was determined on a numerical scale from 1 to 10 and involved headaches, back pain and leg pain.', 'detailedDescription': 'Background. Body pain of various degrees and types can complicate human life. Regular physical exercise and good mental health can both have protective effects on the body and its physical health. Physical exercises may also, in some aspects, be particularly important for older women who experience varying degrees of headache, back pain, and/or leg pain chronically. The purpose of the study was to analyze the effects of the Dalcroze Eurhythmic Method on headaches, backaches, and leg pains among older women.\n\nMethods. Sixty-two blinded participants with pain were randomized into two groups. Women (65 to 82 years old) who had reported the occurrence of headaches, backaches, or leg pains during the 3 months prior to the beginning of the randomized controlled trial study were identified. The participants in the pre-test and post-test used the 0-10 Numeric Pain Rating Scale to quantify their pain. Women from the experimental group participated for 3 months in the physical exercise program based on the Dalcroze Eurhythmics Method.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* female, 65+ years old, physical and mental state that allows them to participate in the exercise program (ability to follow the instructions), community dwelling\n\nExclusion Criteria:\n\n* taking analgesics indelibly, Parkinson's or Alzheimer's disease, using social assistance or nursing care."}, 'identificationModule': {'nctId': 'NCT06264102', 'briefTitle': 'Influence of Dalcroze Eurhythmics on Pains in Older Women', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': "Effect of Dalcroze Eurhythmics' Physical Exercises on Headaches, Backaches, and Leg Pains in Older Women: a Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '2024/1/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Physical exercises program', 'interventionNames': ['Other: Physical exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Were advised not to change anything about their current lifestyle, and in particular not to undertake any new structured physical activity.'}], 'interventions': [{'name': 'Physical exercise program', 'type': 'OTHER', 'description': 'Training sessions took place twice a week for 45 minutes each over a period of 12 weeks. Each training included rhythmic exercises using the Jaques-Dalcroze Eurhythmics (JDE) method with piano accompaniment and electronically played music. Training sessions were conducted by a JDE specialist.\n\nExercises with the use of this method consist mainly in the repetition of preset musical sequences using body movements. In addition to the physical layer, the cognitive layer was equally important: while performing a given movement exercise, participants often had to focus in order to react appropriately to additional tasks, such as changes in sound pitch and rhythm of the piece.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-871', 'city': 'Poznan', 'state': 'Wielkopolska', 'country': 'Poland', 'facility': 'Poznan University of Physical Education', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'JANUSZ MACIASZEK, PROF', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poznan University of Physical Education'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}