Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-31 @ 12:45 AM
Study NCT ID:
NCT04254159
Status:
COMPLETED
Last Update Posted:
2022-02-10
First Post:
2020-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2020-02-02', 'studyFirstSubmitQcDate': '2020-02-02', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sit to Stand Test', 'timeFrame': '8 weeks', 'description': 'Quadriceps muscle endurance will be evaluated with this test'}, {'measure': 'Muscle Strength Test', 'timeFrame': '8 weeks', 'description': 'Jtech Commander Power Track Muscle Testing Dynamometer, USA which quantifies muscle power will be used to assess the maximum voluntary contractions of quadriceps muscle in pound meter.'}, {'measure': 'Six Minute Walking Test', 'timeFrame': '8 weeks', 'description': 'Six-Minute Walking Test (6MWT) was used to evaluate functional capacity of volunteers.'}, {'measure': 'Asthma Quality of Life Scale (AQOL)', 'timeFrame': '8 weeks', 'description': 'Asthma quality of life questionnaire will utilize to assess quality of life of participants over two weeks prior to interview which is validated in Turkish population by Alpaydın et al.'}], 'secondaryOutcomes': [{'measure': 'Modified Medical Research Council (MMRC) Dyspnea Scale', 'timeFrame': '8 weeks', 'description': 'Perceived dyspnea which is any restrictions performing daily living activities will be measured by MMRC dyspnea scale.'}, {'measure': 'Physical Activity Questionnaire for Elderly (PASE)', 'timeFrame': '8 weeks', 'description': 'We will assess the physical activity status of the oler patients with asthma by using Physical Activity Questionnaire for Elderly (PASE).'}, {'measure': 'Time Up and Go Test', 'timeFrame': '8 weeks', 'description': 'Time Up and Go Test (TUG) will be used to evaluate the risk for falling in older patients with asthma.'}, {'measure': 'Pulmonary Function Test', 'timeFrame': '8 weeks', 'description': 'Medical International Research Spirodoc® Spiro, Italy brand named spirometry will be used to evaluate pulmonary functions of volunteers.'}, {'measure': 'Respiratory Muscle Strength Testing', 'timeFrame': '8 weeks', 'description': 'The Micro Medical Micro RPM, England respiratory pressure meter will be utilized to measure respiratory muscle strength.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Neuromuscular Electrical Stimulation', 'Quadriceps Muscle Strength', 'Quality of Life'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of the randomized controlled study is to investigate the effects of NMES superimposed on voluntary contraction combined with patient education and exercise training program in patients with chronic obstructive pulmonary disease.', 'detailedDescription': 'When initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: Superimposed NMES group (SG) or control group (CG).\n\nAll volunteers will receive an COPD patient education program for once and conventional physiotherapy exercise program for COPD with the duration of 8 weeks. Additionally, superimposed NMES will be applied on quadriceps muscle of both limbs at the same time with voluntarily contraction of quadriceps muscle in SG.\n\nAll patients will be assessed in terms of functional capacity, pulmonary functions, quadriceps muscle endurance and strength, dyspnea, respiratory muscle strength and quality of life at the baseline and at the end of study. Data will be collected from all the patients at baseline and at the end of study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Having stable asthma\n2. Participating to the study in a voluntary basis\n3. Being 65 - 75 years old\n4. Having 2 point or over score from "Modified Medical Research Council (MMRC)" Dyspnea Scale\n5. Being motivated to participate and follow exercise program\n\nExclusion Criteria:\n\n1. Having an asthma exacerbation in a last month\n2. Other respiratory problems\n3. Ischemic heart disease\n4. Congestive heart disease\n5. Pacemaker\n6. Acute Cor Pulmonale\n7. Neurological Diseases\n8. Osteoporosis\n9. Smoking'}, 'identificationModule': {'nctId': 'NCT04254159', 'briefTitle': 'The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'The Effects of Neuromuscular Electrical Stimulation to Muscle Strength, Functional Capacity and Quality of Life in Older Patients With Asthma: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ElifD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuromuscular Electrical Stimulation Group', 'description': 'Asthma Education Aerobic Exercise Quadriceps Strengthening by superimposed NMES', 'interventionNames': ['Other: Superimposed Neuromuscular Electrical Stimulation', 'Behavioral: Patient Education Program', 'Other: Aerobic Exercise Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Asthma Education Aerobic Exercise Quadriceps Strengthening', 'interventionNames': ['Other: Quadriceps Strengthening', 'Behavioral: Patient Education Program', 'Other: Aerobic Exercise Training']}], 'interventions': [{'name': 'Superimposed Neuromuscular Electrical Stimulation', 'type': 'OTHER', 'description': 'NMES will be applied during each strengthening exercise session. A dual channel NMES stimulation device will be used with biphasic symmetric constant current impulses with a pulse width 300ms, a frequency of 50 Hz and a duty cycle of 10s on and 20s off protocol for 3 days a week for eight weeks.', 'armGroupLabels': ['Neuromuscular Electrical Stimulation Group']}, {'name': 'Quadriceps Strengthening', 'type': 'OTHER', 'description': 'Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.', 'armGroupLabels': ['Control Group']}, {'name': 'Patient Education Program', 'type': 'BEHAVIORAL', 'description': 'The aim of patient education is to increase awareness of patients about COPD and develop skills to better manage their disease. The patient education will be performed at least once via face to face interview. Education topics will be covered basic information about COPD, environmental risk factors, monitoring and managing the signs and symptoms of their disease, energy conservation techniques and relaxation positions to reduce dyspnea and usage of a specific inhaler.', 'armGroupLabels': ['Control Group', 'Neuromuscular Electrical Stimulation Group']}, {'name': 'Aerobic Exercise Training', 'type': 'OTHER', 'description': 'Exercise training will be comprised of cardiovascular endurance training with cycle ergometer and lower extremity strength training. The exercises will be done 3 days a week at the clinic under the supervision of physiotherapist. Total duration of exercise training will last for 8 weeks', 'armGroupLabels': ['Control Group', 'Neuromuscular Electrical Stimulation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34736', 'city': 'Istanbul', 'state': 'Kadıköy', 'country': 'Turkey (Türkiye)', 'facility': 'Kadıköy Municipality Social Life Center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kadikoy Municipality Social Life Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Elif Develi', 'investigatorAffiliation': 'Yeditepe University'}}}}