Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-11 @ 3:29 AM
Study NCT ID:
NCT05501457
Status:
UNKNOWN
Last Update Posted:
2022-08-15
First Post:
2022-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Muscle Training on Activities of Daily Living in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 Minute Walk Test (6 MWT):', 'timeFrame': '4 weeks', 'description': 'they could walk for 6 minutes, according to heart rate, blood pressure, respiratory rate, finger oxygen saturation, the walking distance at the end of walking, and dyspnea score according to the Modified Borg Scale (MBS) at the beginning and end of walking was recorded. Change from baseline 6 Minute walking performance after 4 weeks will be examined.'}], 'secondaryOutcomes': [{'measure': 'Modified Borg Scale (MBS):', 'timeFrame': '4 weeks', 'description': 'It consists of 10 items that define the severity of dyspnea according to their degrees. Change from baseline dyspnea after 4 weeks will be examined.'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ):", 'timeFrame': '4 weeks', 'description': 'This questionnaire was developed specifically to determine the severity of the disease in COPD and asthma. Change from baseline severity of the disease after 4 weeks will be examined.'}, {'measure': 'Beck Depression Inventory (BDI):', 'timeFrame': '4 weeks', 'description': 'It measures the behavioral findings of depression in adolescents and adults. Change from baseline depression status after 4 weeks will be examined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Pulmonary rehabilitation', 'Neuromuscular electrical stimulation'], 'conditions': ['Quality of Life', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death. COPD is identified by persistent airflow limitation and is associated with progressively worsening lung function, dyspnea, health-related quality of life (HRQOL), and impaired exercise capacity. Poor exercise capacity is a common finding of chronic obstructive pulmonary disease (COPD). Central cardiopulmonary factors, respiratory muscle dysfunction, gas exchange abnormalities, and skeletal muscle dysfunction all play a role in limiting exercise capacity The aim of this study is to investigate the effects of neuromuscular electrical stimulation applied to different muscle groups (quadriceps femoris and gastrocnemius muscles) on exercise performance and quality of life in patients with stable COPD and compare it with standard treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18-75 years old,\n* Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist,\n* PaO2 \\>55 mm Hg, PaCO2 \\<45 mmHg in room air.\n\nExclusion Criteria:\n\n* Exacerbation,\n* Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing),\n* Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia),\n* Musculoskeletal disorder (conditions affecting exercise ability),\n* Difficulty communicating.'}, 'identificationModule': {'nctId': 'NCT05501457', 'briefTitle': 'The Effect of Different Muscle Training on Activities of Daily Living in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Hitit University'}, 'officialTitle': 'Comparison of the Effects of Quadriceps and Gastrocnemius Muscle Training on Activities of Daily Living in COPD', 'orgStudyIdInfo': {'id': 'HititUApayas'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The gastrocnemius group', 'description': 'The patients in the first group (n=15) were given a pulmonary rehabilitation program and additionally 20 minutes of Neuromuscular electrical stimulation (Group 1) to the gastrocnemius muscle,', 'interventionNames': ['Device: Muscle strengthening with neuromuscular electrical stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'The quadriceps femoris group', 'description': 'The second group was given a pulmonary rehabilitation program and an additionally 20 minutes of neuromuscular electrical stimulation to the quadriceps femoris muscle (Group 2),', 'interventionNames': ['Device: Muscle strengthening with neuromuscular electrical stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'The control group', 'description': 'The third group, which was the control group, was given only a pulmonary rehabilitation program (Group 3).', 'interventionNames': ['Device: Muscle strengthening with neuromuscular electrical stimulation']}], 'interventions': [{'name': 'Muscle strengthening with neuromuscular electrical stimulation', 'type': 'DEVICE', 'description': "The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.", 'armGroupLabels': ['The control group', 'The gastrocnemius group', 'The quadriceps femoris group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19000', 'city': 'Çorum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ahmet Payas', 'role': 'CONTACT', 'email': 'ahmetpayas@hitit.edu.tr', 'phone': '05343483399'}], 'facility': 'Hititi University Sungurlu Vocational School', 'geoPoint': {'lat': 40.54889, 'lon': 34.95333}}], 'centralContacts': [{'name': 'Ahmet Payas, Dr', 'role': 'CONTACT', 'email': 'ahmetpayas@hitit.edu.tr', 'phone': '05343483399'}], 'overallOfficials': [{'name': 'Ahmet Payas, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A short summary of the study can be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hitit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ahmet Payas', 'investigatorAffiliation': 'Hitit University'}}}}