Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-30 @ 4:50 AM
Study NCT ID:
NCT06278259
Status:
RECRUITING
Last Update Posted:
2025-08-13
First Post:
2024-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telerehabilitation Program Bases Aerobic and Baduanjin Exercises in Post Stroke Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-22', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'six-minute walk test', 'timeFrame': '12 weeks', 'description': 'The 6MWT is a reliable and good measure of functional capacity. The test will be carried out according to the guidelines set forth by the American Thoracic Society (ATS).'}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': '12 weeks', 'description': 'mini mental state examination'}, {'measure': 'sleep quality', 'timeFrame': '12 weeks', 'description': 'The Pittsburgh Sleep Quality Index'}, {'measure': 'functional independence measure', 'timeFrame': '12 weeks', 'description': 'FIM was developed to measure the ability of stroke patients to do daily tasks to assess changes in their functional status. The 18 items consist of 13 items that define a motor ability disorder'}, {'measure': 'physical function', 'timeFrame': '12 weeks', 'description': 'physical performance battery'}, {'measure': 'berg balance scale', 'timeFrame': '12 weeks', 'description': 'A common, standardized tool for assessing balance in stroke patients is the BBS. The scale has 14 components, including transfers, standing on one leg, standing to sitting, standing without assistance, and sitting to standing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'It is an interventional study in which 68 stroke patients are estimated to be enrolled according to random allocation and will be divided into two groups. The study group participants will be involved in Telerehabilitation sessions, which will be based on aerobic exercises, guided by video with the Baduanjin exercise program; the control group will receive the same aerobic exercises only', 'detailedDescription': "It is an interventional study in which 68 stroke patients are estimated to enroll according to random allocation and will be divided into two groups. The study group participants will be involved in telerehabilitation sessions based on aerobic exercises guided by video. The telerehabilitation program will be moderately intense aerobic exercise 3 times per week and will be 3 sessions/week for 3 months.\n\n. The exercise intensity of each telerehabilitation session will be individually adjusted by the participants' Modified Borg perceived exertion and maximum heart rate. The Baduanjin exercise program is delivered individually, at each patient's home, through telerehabilitation, with direct remote supervision by a physiotherapist. The control group will receive the same aerobic exercises only."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • The subject selection will be according to the following criteria:\n\n * All Patients of this study will be diagnosed as stroke and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021).\n * Age of patients will be more than or equal 65years (males and females).\n * All patients will be hemodynamically stable.\n\nExclusion Criteria:\n\n* • The potential participants will be excluded if they meet one of the following criteria:\n\n * Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness.\n * Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD.\n * Patients with psychiatric disorders.\n * Patients with unstable cardiovascular conditions.\n * uncontrolled hypertension, or other concomitant respiratory diseases\n * participate at any research or rehabilitation program during the period of this study'}, 'identificationModule': {'nctId': 'NCT06278259', 'briefTitle': 'Telerehabilitation Program Bases Aerobic and Baduanjin Exercises in Post Stroke Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Telerehabilitation Program Bases Aerobic and Baduanjin Exercises on Cognition , Sleep Quality and Physical Performance in Post Stroke Elderly Patients', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': "The telerehabilitation program is moderately intense aerobic exercise 3 times per week and included 3 parts: warm-up, central part, and cool-down. Each session : 30 min, 3 sessions/ week for 3 months.With the Baduanjin exercise program is delivered individually, at each patient's home, through telerehabilitation, with direct remote supervision by a physiotherapist", 'interventionNames': ['Other: Telerehabilitation program bases aerobic and Baduanjin exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'The control group will receive the same aerobic exercises only', 'interventionNames': ['Other: Telerehabilitation program bases aerobic exercises']}], 'interventions': [{'name': 'Telerehabilitation program bases aerobic and Baduanjin exercises', 'type': 'OTHER', 'description': "It is an interventional study in which 68 stroke patients are estimated to enroll according to random allocation and divided into two groups. The study group participants involve in Telerehabilitation sessions is based on aerobic exercises, guided by video. The telerehabilitation program is aerobic exercise 3 times per week for 3 months. With the Baduanjin exercise program is delivered individually, at each patient's home, through telerehabilitation, with direct remote supervision by a physiotherapist", 'armGroupLabels': ['experimental group']}, {'name': 'Telerehabilitation program bases aerobic exercises', 'type': 'OTHER', 'description': 'The telerehabilitation program is aerobic exercise 3 times per week for 3 months.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Cairo', 'state': 'Dokki', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'marwa M elsayed, phd', 'role': 'CONTACT', 'email': 'marwadd999@gmail.com', 'phone': '01156033818', 'phoneExt': '02'}, {'name': 'marwa M elsayed, ph.d', 'role': 'CONTACT', 'email': 'marwadd999@gmail.com', 'phone': '01156033818', 'phoneExt': '02'}], 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'marwa elsayed, PhD', 'role': 'CONTACT', 'email': 'marwa.elsaid@cu.edu.eg', 'phone': '0201156033818'}], 'overallOfficials': [{'name': 'marwa elsayed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'url': 'https://www.ekb.com', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'one year', 'ipdSharing': 'YES', 'description': 'sharing', 'accessCriteria': 'after acceptance of the publishing journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'marwa mahmoud elsayed mahmoud', 'investigatorAffiliation': 'Cairo University'}}}}