Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-08 @ 1:28 AM
Study NCT ID:
NCT04039334
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2019-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Creative Dance Based Exercise Training on Respiratory, Balance and Cognitive Functions, Respiratory and Peripheral Muscle Strength and Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Function Test', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline forced vital capacity (FVC) at 8 weeks.'}, {'measure': 'Respiratory Function Test', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline forced forced expiratory volume in 1 second at 8 weeks.'}, {'measure': 'Respiratory Function Test', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline peak expiratory flow (PEF) at 8 weeks.'}, {'measure': 'COPD Assessment Test (CAT)', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline CAT score at 8 weeks.'}, {'measure': 'BODE Index', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline BODE score at 8 weeks.'}, {'measure': 'Balance', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline postural stability test score in BIODEX Balance System at 8 weeks.'}, {'measure': 'Balance', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline limits of stability test score in BIODEX Balance System at 8 weeks.'}, {'measure': 'Respiratory Muscle Strength', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline maximum inspiratory pressure at 8 weeks.'}, {'measure': 'Respiratory Function Test', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline maximum expiratory pressure at 8 weeks.'}, {'measure': 'Functional Capacity', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline distance covered in six minute walk test at 8 weeks.'}, {'measure': 'Change from baseline handgrip strength at 8 weeks.', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline m. quadriceps strength at 8 weeks.'}, {'measure': 'Change from baseline handgrip strength at 8 weeks.', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline m. biceps strength at 8 weeks.'}, {'measure': 'Change from baseline handgrip strength at 8 weeks.', 'timeFrame': 'Eight weeks', 'description': 'Change from baseline handgrip strength at 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Creative Dance', 'Exercise Training', '6 Minute Walk Test', 'Pulmonary Function Test', 'Postural Stability', 'Cognitive Functions', 'Muscle Strength'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': "COPD is a common, preventable and treatable disease associated with an increased chronic inflammatory response of the airways and lungs to harmful gases and particles and characterized by progressive airflow restriction, which is usually progressive. Exercise intolerance is one of the most important outcomes of COPD. Dyspnea and leg fatigue are the main symptoms that limit exercise and patients restrict their activity to avoid these disturbing conditions. Exercise training is the most appropriate method for improving exercise tolerance and muscle function. It is considered and recommended by ERS and ATS as an essential component of PR. Endurance training is considered to be one of the most important components of the PR program. Walking, running, cycling, stair climbing, dancing are examples of endurance exercises. Dance-based exercise training; It is an entertaining method that increases physical, functional, cognitive, emotional and social integration. This alternative method has frequently been tried in the literature in the treatment of Parkinson's, cancer and psychiatric diseases and its effects on functional capacity, balance, and quality of life have been demonstrated. The importance of our research; This is the first study to apply dance based exercise training in chronic respiratory diseases.\n\nThe aim of this study was to investigate the effect of creative dance based exercise training on respiratory, balance and cognitive functions, respiratory and peripheral muscle strength and functional capacity in COPD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having FEV1 / FVC \\<70% from pulmonary function test\n* Being older than 18 years\n* To be able to read and understand Turkish\n\nExclusion Criteria:\n\n* No exacerbation in 8 weeks.\n* Attending current or regular exercise training in the last 1 year\n* Having diagnosed vision, hearing, vestibular or neurological problems that may affect balance\n* Having orthopedic, musculoskeletal or cardiovascular comorbid conditions that may affect ambulation\n* Being on long-term oxygen therapy'}, 'identificationModule': {'nctId': 'NCT04039334', 'briefTitle': 'The Effects of Creative Dance Based Exercise Training on Respiratory, Balance and Cognitive Functions, Respiratory and Peripheral Muscle Strength and Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'The Effects of Creative Dance Based Exercise Training on Respiratory, Balance and Cognitive Functions, Respiratory and Peripheral Muscle Strength and Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'bvumkaya01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 week. All exercise sessions will be performed at home.', 'interventionNames': ['Other: Conventional Chest Physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Training Group', 'description': 'In addition to conventional chest physiotherapy programme, patients in this group will also receive creative dance based exercise training for 60 minutes, 2 times in a week for 8 weeks. All exercise sessions will be supervised in a clinic per week.', 'interventionNames': ['Other: Conventional Chest Physiotherapy', 'Other: Creative Dance Based Exercise Training']}], 'interventions': [{'name': 'Conventional Chest Physiotherapy', 'type': 'OTHER', 'description': 'Conventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques.', 'armGroupLabels': ['Control Group', 'Training Group']}, {'name': 'Creative Dance Based Exercise Training', 'type': 'OTHER', 'description': 'Creative dance based exercise training will be given under the supervision of a physiotherapist who takes creative dance instructor training 2 days and 60 minutes per week.', 'armGroupLabels': ['Training Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University, Department of Physiotheraphy and Rehabilitation', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Asistant, PT', 'investigatorFullName': 'Meltem Kaya', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}