Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03636633
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Forced Vital Capacity (FVC) at 4 weeks', 'timeFrame': 'Four weeks'}, {'measure': 'Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks', 'timeFrame': 'Four weeks'}, {'measure': 'Change from baseline Peak Expiratory Flow (PEF) at 4 weeks', 'timeFrame': 'Four weeks'}, {'measure': 'Change from baseline maximum inspiratory pressure (MIP) at 4 weeks', 'timeFrame': 'Four weeks'}, {'measure': 'Change from baseline maximum expiratory pressure (MEP) at 4 weeks', 'timeFrame': 'Four weeks'}, {'measure': 'Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks', 'timeFrame': 'Four weeks'}, {'measure': 'Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks', 'timeFrame': 'Four weeks'}], 'secondaryOutcomes': [{'measure': 'Fatigue Severity Scale', 'timeFrame': 'Four weeks', 'description': "The 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Assessment type: Patient reported outcomes.The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity."}, {'measure': 'Fatigue Impact Scale', 'timeFrame': 'Four weeks', 'description': 'The fatigue impact scale was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Respondents are asked to rate the extent to which fatigue has interfered with certain aspects of their day-to-day functioning using a scale that ranges from 0 ("no problem") to 4 ("extreme problem"). Scores are then tallied to produce an overall score with a potential maximum of 160. Subscale scores can also be calculated to give a more nuanced impression of fatigue.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic Heart Surgery', 'Inspiratory Muscle Training', 'Pulmonary Function Test', '6-Minute Walk Test', 'Respiratory Muscle Strength', 'Functional Capacity'], 'conditions': ['Robotic Surgical Procedures', 'Heart Diseases']}, 'descriptionModule': {'briefSummary': "During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being suitable for robotic cardiac surgery,\n* Being hospitalized to have a robotic heart surgery,\n* No complications during surgery,\n* To be extubated in intensive care unite after surgery ,\n* Stable clinical condition,\n* To be transferred from ICU to the hospital room on the first day after surgery.\n\nExclusion Criteria:\n\n* Chronic obstructive pulmonary disease,\n* Unstable angina,\n* Acute decompensated heart failure,\n* Acute pericarditis and myocarditis,\n* Complex arrhythmia,\n* Uncontrolled hypertension,\n* Serious orthopedic and neurological impairment,\n* Uncontrolled diabetes,\n* Body Mass Index \\> 30.'}, 'identificationModule': {'nctId': 'NCT03636633', 'briefTitle': 'The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery', 'orgStudyIdInfo': {'id': 'ATADEK-2018-2/55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Standard respiratory physiotherapy\n\nPatients in this group will receive standard respiratory physiotherapy two times a day, 7 days a week for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves.', 'interventionNames': ['Other: Standard respiratory physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Training Group', 'description': 'Standard respiratory physiotherapy and inspiratory muscle train\n\nIn addition to the standard respiratory physiotherapy program, patients in this group will receive 3 sets of inspiratory muscle training with 10 repetitions twice a day for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves.', 'interventionNames': ['Other: Standard respiratory physiotherapy and inspiratory muscle training']}], 'interventions': [{'name': 'Standard respiratory physiotherapy', 'type': 'OTHER', 'description': 'Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques.', 'armGroupLabels': ['Control Group']}, {'name': 'Standard respiratory physiotherapy and inspiratory muscle training', 'type': 'OTHER', 'description': 'Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. Addition to that, threshold IMT device will be used for the training. Training intensity will set at 40% of the maximum inspiratory pressure.', 'armGroupLabels': ['Training Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34457', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Acıbadem MAA University Maslak Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, Research Assistant at Faculty of Health Sciences, Acibadem University', 'investigatorFullName': 'Aslı İrem Dönmez', 'investigatorAffiliation': 'Acibadem University'}}}}