Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 7:58 PM
Study NCT ID:
NCT04958759
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2021-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Inspiratory Muscle Training in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory muscle strength', 'timeFrame': '10 minutes', 'description': 'Respiratory muscle strength will be evaluated using mouth pressure device'}, {'measure': 'Respiratory muscle endurance', 'timeFrame': '10 minutes', 'description': 'Respiratory muscle endurance will be evaluated using incremental load test'}, {'measure': 'Pulmonary function', 'timeFrame': '5 minutes', 'description': 'Pulmonary functions will be evaluated using spirometry'}, {'measure': 'Peripheral muscle strength', 'timeFrame': '5 minutes', 'description': 'Peripheral muscle strength will be evaluated using dynamometer'}, {'measure': 'Endurance of trunk muscles', 'timeFrame': '10 minutes', 'description': 'Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test'}, {'measure': 'Lower extremity muscle endurance', 'timeFrame': '1 minutes', 'description': 'Lower extremity muscle endurance will be evaluated using sit-to-stand test'}, {'measure': 'Functional capacity', 'timeFrame': '10 minutes', 'description': 'Functional capacity will be evaluated using six-minute walk test'}, {'measure': 'Diaphragm thickness and mobility', 'timeFrame': '20 minutes', 'description': 'Diaphragm thickness and mobility will be evaluated using ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Balance', 'timeFrame': '5 minutes', 'description': 'Balance will be evaluated using timed up and go test'}, {'measure': 'Static balance', 'timeFrame': '5 minutes', 'description': 'Balance will be evaluated using one-legged standing test'}, {'measure': 'Posture', 'timeFrame': '5 minutes', 'description': 'Posture will be evaluated using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent, 1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent (0-2), very good (3-4), good (5-7), fair (8-11) and poor (\\>12).'}, {'measure': 'Qol', 'timeFrame': '10 minutes', 'description': 'Quality of life will be evaluated using Nottingham Health Profile'}, {'measure': 'Cognitive function', 'timeFrame': '5 minutes', 'description': 'Cognitive function will be evaluated using Standardised Mini-Mental State Examination'}, {'measure': 'Fatigue', 'timeFrame': '5 minutes', 'description': 'Fatigue will be evaluated using Multidimensional Assessment of Fatigue scale'}, {'measure': 'Physical activity', 'timeFrame': '5 minutes', 'description': 'Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form'}, {'measure': 'Endothelial function', 'timeFrame': '10 minutes', 'description': 'Endothelial function will be evaluated using echocardiography. After a resting baseline Brachial artery diameter will be recorded, the cuff used in blood pressure measurement will be inflated 25-50 mmHg above the systolic blood pressure value and maintaining that pressure for 5 min. The brachial artery diameter will be measured again after the cuff is deflated.'}, {'measure': 'Aortic stiffness', 'timeFrame': '10 minutes', 'description': 'Aortic stiffness will be evaluated using transthoracic echocardiography. Aortic diameters can be measured by M-mode tracing of the level of 3-4 cms above the aortic valve during diastole and systole'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory muscle'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Effects of functional inspiratory muscle training by telerehabilitation on respiratory and peripheral functions, functional capacity, diaphragm thickness and mobility, posture, quality of life, cognitive function, fatigue, physical activity, endothelial function and aortic stiffness in patients with chronic kidney disease will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic kidney disease not receiving dialysis\n* Access to the online program\n* Volunteering to participate in the research\n\nExclusion Criteria:\n\n* Having a musculoskeletal problem\n* Having decompensated diabetes\n* Having uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT04958759', 'briefTitle': 'Functional Inspiratory Muscle Training in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effects of Functional Inspiratory Muscle Training on Respiratory and Peripheral Muscle Functions in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'KA-20086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional Inspiratory Muscle Training Group', 'description': 'Functional inspiratory muscle training in patients with chronic kidney disease', 'interventionNames': ['Other: Functional Inspiratory Muscle Training', 'Other: Inspiratory Muscle Training']}, {'type': 'EXPERIMENTAL', 'label': 'Inspiratory Muscle Training Group', 'description': 'Inspiratory muscle training in patients with chronic kidney disease', 'interventionNames': ['Other: Inspiratory Muscle Training']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Breathing exercises in patients with chronic kidney disease', 'interventionNames': ['Other: Breathing exercises']}], 'interventions': [{'name': 'Functional Inspiratory Muscle Training', 'type': 'OTHER', 'description': 'The inspiratory muscle training program will be consist of 4 weeks of foundation inspiratory muscle training and 6 weeks of functional inspiratory muscle training', 'armGroupLabels': ['Functional Inspiratory Muscle Training Group']}, {'name': 'Inspiratory Muscle Training', 'type': 'OTHER', 'description': 'The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training', 'armGroupLabels': ['Functional Inspiratory Muscle Training Group', 'Inspiratory Muscle Training Group']}, {'name': 'Breathing exercises', 'type': 'OTHER', 'description': 'The program will be consist of 10 weeks of breathing exercises', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University, Faculty of Physical Therapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Merve Firat, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Naciye Vardar-Yagli, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Tolga Yildirim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Deniz İnal-İnce, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Melda Saglam, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Ebru Calik-Kutukcu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Ahmet Hakan Ates, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Selin Ardali-Duzgun, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Merve Firat', 'investigatorAffiliation': 'Hacettepe University'}}}}