Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 3:31 PM
Study NCT ID:
NCT06928805
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2025-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters
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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-04-07', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': '4 weeks later'}, {'measure': 'pulse', 'timeFrame': '4 weeks later'}, {'measure': 'respiratory rate', 'timeFrame': '4 weeks later'}, {'measure': 'saturation', 'timeFrame': '4 weeks later'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': '4 weeks later'}, {'measure': 'Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': '4 weeks later'}, {'measure': 'FEV1/FVC ratio', 'timeFrame': '4 weeks later'}, {'measure': 'Peak Expiratory Flow (PEF)', 'timeFrame': '4 weeks later'}, {'measure': 'Modified Borg Dyspnea Scale (MBS)', 'timeFrame': '4 weeks later', 'description': 'MBS determines the severity of dyspnea at rest and during exertion. It consists of 10 items that define the severity of dyspnea according to its degree. A score of 0 indicates no dyspnea, and a score of 10 indicates very severe dyspnea.'}, {'measure': '6 Minute Walking Test (6MWT)', 'timeFrame': '4 weeks later', 'description': 'The test evaluates functional exercise capacity by measuring the distance in meters that the patient will cover in 6 minutes by walking as fast as possible but without running in a 30-meter uninterrupted corridor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease', 'Breathing Techniques', 'Forward-Leaning Position', 'Physiological Parameters'], 'conditions': ['Chronic Obstructive Pulmonary Disease, COPD']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the effects of balloon inflation and pursed-lip breathing exercises, in addition to the forward-leaning position, on physiological parameters in individuals with Chronic Obstructive Pulmonary Disease (COPD).\n\nThe hypotheses of the study are as follows:\n\nH1\\_1: The forward-leaning position and balloon inflation breathing exercise have a positive effect on physiological parameters in patients with Chronic Obstructive Pulmonary Disease (COPD).\n\nH1\\_2: The forward-leaning position and pursed-lip breathing exercise have a positive effect on physiological parameters in patients with COPD.\n\nH1\\_3: There is a significant difference in physiological parameters between the balloon inflation and pursed-lip breathing exercise groups and the control group.\n\nWithin this scope, the study will be conducted with three groups:\n\nIntervention Group 1: Balloon inflation exercise applied in addition to the forward-leaning position.\n\nIntervention Group 2: Pursed-lip breathing exercise applied in addition to the forward-leaning position.\n\nControl Group: Standard practice implemented in the institution where the study is conducted.\n\nParticipants:\n\n* A home exercise program will be designed for both intervention groups, allowing them to perform the exercises independently each day.\n* The exercises will start with three sessions per day and will be increased by one session each week, continuing for a total of four weeks.\n* Participants will visit the outpatient clinic in the 4th week for assessments and tests.\n* Patients will be contacted weekly by the researcher via phone to ensure adherence to the program.', 'detailedDescription': "The exercise program will be determined in collaboration with a respiratory physiotherapist and implemented by the researcher. Accordingly, patients with stage II-III COPD (as determined by a physician) who visit the pulmonology outpatient clinic of the relevant hospital and meet the inclusion criteria will be given brief information about respiratory exercises, their benefits, and duration. They will then be instructed on how to perform the exercises through verbal commands for approximately 30 minutes. At the end of the session, the exercise guidelines will be practiced under the supervision of the researcher.\n\nBefore starting, the patient will be seated in a chair and allowed to rest for about 15 minutes. The patient will be informed about how to perform the walking test, the expected walking pace, and that they can stop and rest if they feel fatigued. Then, the patient will be asked to walk at a brisk pace for six minutes under the supervision of the researcher. During the walk, the researcher will continuously monitor the patient's oxygen saturation using a handheld pulse oximeter. If the patient exhibits signs of excessive sweating, pallor, or a significant drop in oxygen levels, the test will be terminated early.\n\nBefore and after the test, blood pressure, pulse rate, respiratory rate, oxygen saturation \\[SpO2\\], and dyspnea score using the Modified Borg Scale will be assessed, and the distance the patient walks in six minutes will be recorded. The six-minute walk test will be repeated at the end of the study. Subsequently, the patient will undergo a pulmonary function test, and the values for FVC, FEV1, FEV1/FVC ratio, and peak expiratory flow will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have no communication and cooperation problems,\n* Can speak and understand Turkish,\n* Have a baseline saturation of \\>90%,\n* Have been diagnosed with Stage II and Stage III COPD,\n* Have not had any infection or COPD exacerbation for at least 3 months,\n* Have not participated in a pulmonary rehabilitation program in the last 3 months,\n* Can walk without assistance,\n* Do not have serious and/or unstable heart disease, neuromuscular disease, orthopedic disease or mental illness that may impair their physical activities of daily living,\n* Willing to participate in the study will be included.\n\nExclusion Criteria:\n\n* Patients who have been hospitalized since the start of the study,\n* Those receiving continuous oxygen therapy,\n* Those who have cooperation problems,\n* Those who cannot adapt to exercise,\n* Those who have 2-3 or more acute attacks per year,\n* Those with a history of pulmonary hypertension, malignancy, pulmonary thromboembolism, obstructive sleep apnea, unstable angina or myocardial infarction,\n* Patients with a pulse rate over 120/minute will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06928805', 'briefTitle': 'The Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Determination of the Effects of Two Different Breathing Techniques and Forward-Leaning Position on Physiological Parameters in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'SaglikBilimleriU Semra Aciksoz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pursed-lip breathing exercise', 'interventionNames': ['Other: Pursed-lip breathing exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Balloon inflation exercise', 'interventionNames': ['Other: Balloon inflation exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Standard treatment', 'interventionNames': ['Other: Control (Standard treatment)']}], 'interventions': [{'name': 'Balloon inflation exercise', 'type': 'OTHER', 'description': 'Balloon inflation exercise was applied in addition to the forward-leaning position.', 'armGroupLabels': ['Balloon inflation exercise']}, {'name': 'Pursed-lip breathing exercise', 'type': 'OTHER', 'description': 'The pursed-lip breathing exercise was applied in addition to the forward-leaning position.', 'armGroupLabels': ['Pursed-lip breathing exercise']}, {'name': 'Control (Standard treatment)', 'type': 'OTHER', 'description': 'Standard practice is implemented in the institution where the study is conducted.', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Üsküdar', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences Turkey', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Semra Aciksoz, RN, Assistant Professor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Health Sciences Turkey, Hamidiye Faculty ofNursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}