Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT07181460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Sleep Quality in Elderly Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '16 weeks', 'description': 'The PSQI is a 19-item self-report measure widely used in clinical and research settings that measures sleep quality and sleep-related disturbances based on self-report over a one-month period.'}, {'measure': 'SF-12 / Short Form-12 Health Survey', 'timeFrame': '16 weeks', 'description': 'The SF-12 is a brief, validated health status scale derived from the SF-36 and enhanced to reproduce physical and mental component summary scores with 12 questions to reduce response burden for group comparisons.'}, {'measure': 'Modified Medical Research Council (mMRC) Dyspnea Scale', 'timeFrame': '16 weeks', 'description': 'The mMRC is a brief, five-point self-assessment scale from 0 to 4 that rates the impact of breathlessness on daily activities and is commonly used to classify symptom severity in respiratory diseases such as COPD.'}, {'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': '16 weeks', 'description': 'The TUG test is described as a rapid way to quantify baseline functional mobility and fall risk in which the time it takes for the patient to get up from a chair, walk 3 meters, turn, and sit down again is measured chronometrically.'}, {'measure': '6-Minute Walk Test (6MWT)', 'timeFrame': '16 weeks', 'description': 'The 6MWT is a submaximal exercise capacity test that measures the total distance a patient walks in 6 minutes; detailed guidelines for its application, safety, evaluation, and interpretation have been published by the American Thoracic Society.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Quality', 'Elderly', 'Exercises', 'Telerehabilitation'], 'conditions': ['Sleep Quality']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to examine the effects of regular exercise on sleep quality in older adults. The study will assess changes in sleep quality resulting from a structured exercise program using objective and subjective measurement tools.', 'detailedDescription': 'The sample size of this study consists of a total of 18 (female and male) individuals selected in accordance with the specified inclusion and exclusion criteria.\n\nThe Sociodemographic Patient Information Form, Pittsburgh Sleep Quality Index (PSQI), SF-12/Short Form-12 Health Survey, Modified Medical Research Council Dyspnea Scale, Timed Up and Go Test, and 6-Minute Walk Test will be evaluated at the Kadıköy Municipality Living Center. All evaluations will be collected at the beginning of the study and at the end of the 16th week. Our online exercises will continue for 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 65 years of age or older,\n* Being a resident of the Kadıköy Municipality Social Life House,\n* Being able to independently carry out daily living activities,\n* Not having any serious cardiopulmonary, neurological, or orthopedic health problems that would prevent exercise,\n* Being willing to participate in the study and providing written consent,\n* Being at a level where cognitive status does not prevent participation in exercise.\n\nExclusion Criteria:\n\n* Those with serious cardiopulmonary, neurological, or orthopedic diseases,\n* Individuals who exercise regularly,\n* Individuals who did not complete the study process.'}, 'identificationModule': {'nctId': 'NCT07181460', 'briefTitle': 'The Effect of Exercise on Sleep Quality in Elderly Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'The Effect of Exercise on Sleep Quality in Elderly Individuals', 'orgStudyIdInfo': {'id': 'IrmakS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Study Group', 'description': 'The sample size was determined as 18 elderly individuals.', 'interventionNames': ['Other: Exercises Program']}], 'interventions': [{'name': 'Exercises Program', 'type': 'OTHER', 'description': 'A program of low-intensity, safe, and functional movements was designed for older adults. It included a warm-up, breathing exercises, chair exercises, strength and mobility exercises, balance exercises, stretching, and a cool-down.', 'armGroupLabels': ['Experimental: Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34758', 'city': 'Istanbul', 'state': 'Ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Yeditepe University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Elif Develi, PhD C', 'role': 'CONTACT', 'email': 'elifstn@yahoo.com', 'phone': '0905555936293'}, {'name': 'Mehmet Alperen Pekdaş, PhD C', 'role': 'CONTACT', 'email': 'alperen.pekdas@yeditepe.edu.tr', 'phone': '5379619244'}], 'overallOfficials': [{'name': 'Feryal Subaşı', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeditepe University'}, {'name': 'Dilara Karaoğlu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yeditepe University'}, {'name': 'Deniz Aslan, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Yeditepe University'}, {'name': 'Irmak Sıla Çetinel', 'role': 'STUDY_CHAIR', 'affiliation': 'Yeditepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Elif Develi', 'investigatorAffiliation': 'Yeditepe University'}}}}