Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-31 @ 6:22 PM
Study NCT ID:
NCT05005533
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2021-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Respiratory Muscle Strength and Functional Capacity on Posture and Balance
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2021-08-07', 'studyFirstSubmitQcDate': '2021-08-07', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Inspiratory Pressure', 'timeFrame': '5 minutes', 'description': 'Respiratory muscle strength will be assessed by maximal inspiratory pressure. Values in the normal range indicate normal respiratory muscle strength, low values indicate decreased respiratory muscle strength.'}], 'secondaryOutcomes': [{'measure': 'Posture Assessment', 'timeFrame': '5 minutes', 'description': 'Posture assessment of individuals will be done with the Spinal Mouse device. Individuals will be asked to distribute their weight equally on both lower extremities as much as possible and to stand symmetrically. The angular deviation between each SPINE will be calculated as an angle. While the high angle of deviation indicates that the posture is bad; A low angle of deviation indicates a good posture'}, {'measure': 'Biodex Balance System', 'timeFrame': '5 minutes', 'description': 'Balance assessment will be evaluated with the Biodex Balance System. A high values indicates poor balance, and a low values indicates good balance.'}, {'measure': 'Time Up and Go Test', 'timeFrame': '2 minutes', 'description': 'Time Up and Go Test is a balance test that is frequently used to evaluate the functional mobility of individuals. High times indicate impaired functional mobility; low times indicate good functional mobility.'}, {'measure': 'Short Physical Performance Test', 'timeFrame': '5 minutes', 'description': 'The physical performance of the lower extremities of the individuals will be evaluated with the Short Physical Performance Test. High values indicate deterioration of physical performance; low values indicate good physical performance.'}, {'measure': 'Chronic Obstructive Pulmonary Disease Assessment Test', 'timeFrame': '2 minutes', 'description': 'Chronic Obstructive Pulmonary Disease symptoms are assessed with the Chronic Obstructive Pulmonary Disease Evaluation Test. High values indicate poor health; low values indicate good health'}, {'measure': 'Modified Medical Research Council Scale', 'timeFrame': '2 minutes', 'description': 'The breath assessment test will be evaluated with the Modified Medical Research Council Scale. High values indicate high dyspnea; low values indicate low dyspnea.'}, {'measure': 'Leicester Cough Questionnaire', 'timeFrame': '2 minutes', 'description': 'The cough related quality of life questionnaire will be assessed by the Leicester Cough Questionnaire. Low values indicate poor quality of life associated with cough; high values indicate good quality of life associated with cough'}, {'measure': 'Visual Analog Scale', 'timeFrame': '2 minutes', 'description': 'Pain intensity will be evaluated with a visual analog scale. While high values indicate increased pain intensity; low values indicate low pain intensity'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': '2 minutes', 'description': 'Fatigue will be evaluated with the Fatigue Severity Scale. High values indicate increased fatigue severity; lower values indicate lower fatigue severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Respiratory Muscle Strength', 'Posture', 'Balance', 'Functional Capacity'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, suggestions will be made to help individual postural smoothness and improve physical performance.', 'detailedDescription': 'Chronic Obstructive Pulmonary Disease is a multifaceted disease that results from the interaction between genetic susceptibility and exposure to environmental stimuli. Due to the slow progression and chronic nature of the disease, it creates a growing disease burden on the individual. Considering the data of the Turkish Statistical Institute, the third most common cause of death in Turkey in 2010, 2011 and 2012 was respiratory system diseases. 61.5% of respiratory system deaths in 2012 were due to Chronic Obstructive Pulmonary Disease. Due to the progressive airway obstruction that occurs in Chronic Obstructive Pulmonary Disease, the level of inspiratory muscle strength is restricted and there is an increasing deterioration in the level of functional performance. However, with increasing age, postural problems can be observed in individuals with Chronic Obstructive Pulmonary Disease. Postural problems such as rounded shoulders, increase in thoracic kyphosis and muscle shortness can be observed especially in patients who start to use the auxiliary respiratory muscles continuously due to inspiratory muscle strength. There are few articles investigating the changes in posture, physical performance and inspiratory muscles with the addition of a chronic disease such as Chronic Obstructive Pulmonary Disease to the normal aging process. For this reason, a study titled "The effect of respiratory muscle strength and functional capacity on posture and balance in individuals with Chronic Obstructive Pulmonary Disease with Different Phenotypes" was planned.\n\nAs a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, and suggestions will be made to help individual postural smoothness and improve physical performance.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic obstructive pulmonary disease is a common, preventable and treatable disease characterized by persistent respiratory symptoms and airway limitation due to airway and/or alveolar abnormality resulting from exposure to harmful gases or particles and many factors that cause abnormal lung development.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with Chronic Obstructive Pulmonary Disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria\n* Not having vision, hearing and speech problems\n* Volunteering to participate in the research\n\nExclusion Criteria:\n\n* Have had major surgery in the past few months\n* History of recurrent significant clinical infection\n* Having cognitive problems\n* Unstable angina, previous myocardial infarction (MI),\n* Severe congestive heart failure resistant to medical treatment,\n* Having uncontrolled hypertension,\n* Get cancer\n* Having neurological or musculoskeletal diseases with functional limitations\n* Having suffered an injury, such as a sprain, sprain or fracture of the lower extremity in the last 6 months, unable to perform independent ambulation'}, 'identificationModule': {'nctId': 'NCT05005533', 'briefTitle': 'The Effect of Respiratory Muscle Strength and Functional Capacity on Posture and Balance', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'The Effect of Respiratory Muscle Strength and Functional Capacity on Posture and Balance in Individuals With Different Phenotypes of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'AIBU-FTR-CT-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild and Moderate Severe Group', 'description': 'Individuals with Chronic Obstructive Pulmonary Disease with a Forced Expiratory Volume greater than 50% of the expected value', 'interventionNames': ['Other: Observational']}, {'label': 'Severe and Very Severe Group', 'description': 'Individuals with Chronic Obstructive Pulmonary Disease whose Forced Expiratory Volume is less than 50% of the expected value', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Chronic Obstructive Pulmonary Disease Severity of Individuals by Chronic Obstructive Pulmonary Disease Assessment Test, shortness of breath Modified Medical Research Council scale, cough related quality of life Leicester Cough Questionnaire, respiratory muscle strength with Maximum Inspiratory and Expiratory Pressure, Posture with Spinal Mouse device, pain with Visual Analog Scale, severity of fatigue Fatigue Physical performance of the lower extremities will be evaluated with the Short Physical Performance Test, functional mobility will be evaluated with the Time Up and Go Test, and balance will be evaluated with the Biodex Balance System', 'armGroupLabels': ['Mild and Moderate Severe Group', 'Severe and Very Severe Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Bolu', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Eylem TÜTÜN YÜMİN, Assoc. Prof.', 'role': 'CONTACT', 'email': 'eylemtutun78@hotmail.com', 'phone': '+90 505 676 31 91'}, {'name': 'Ceyhun TOPCUOĞLU, Res. Assist.', 'role': 'CONTACT', 'email': 'ceyhuntopcuoglu1@gmail.com', 'phone': '+90 535 653 51 37'}], 'facility': 'Bolu Abant İzzet Baysal University Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'centralContacts': [{'name': 'Eylem TÜTÜN YÜMİN, Assoc. Prof.', 'role': 'CONTACT', 'email': 'eylemtutun78@hotmail.com', 'phone': '+90 505 676 31 91'}, {'name': 'Ceyhun TOPCUOĞLU, Res. Assist.', 'role': 'CONTACT', 'email': 'ceyhuntopcuoglu1@gmail.com', 'phone': '+90 535 653 51 37'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ceyhun Topcuoğlu', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}