Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04623060
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Volume Interval Training and Resistance Exercise in Individual With Stroke
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Six Minute Walk Test', 'timeFrame': '0, 6 weeks', 'description': 'This test measures the distance that an individual can quickly walk in a period of 6 minutes on a flat surface. Participants will complete one trial with the gait aide prescribed to them. The distance will be recorded. Participants can stop and rest or discontinue to the test at any time.'}], 'secondaryOutcomes': [{'measure': 'Change in 10-meter walk test', 'timeFrame': '0, 6 weeks', 'description': 'This assessment will include four 10-meter walking tasks at maximal comfortable speed.'}, {'measure': 'Change in Lower Limb Muscle Strength', 'timeFrame': '0, 6 weeks', 'description': 'Handheld dynamometer for knee extensor'}, {'measure': 'Change in Timed Up and Go test', 'timeFrame': '0, 6 weeks', 'description': 'Functional Balance'}, {'measure': 'Stroke Impact Scale (SIS)', 'timeFrame': '0,week 6', 'description': 'Quality of Life'}, {'measure': 'Adherence', 'timeFrame': '0 to 6 weeks', 'description': 'Attendance and completion of home-based sessions measured via exercise diary'}, {'measure': 'Adverse Events', 'timeFrame': '0 to 6 weeks', 'description': 'Any adverse event or near miss is required to be reported as standard of care at Selayang Hospital'}, {'measure': 'Patient satisfaction', 'timeFrame': '6 weeks', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low-Volume Interval Training', 'Resistance Training'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'To examine the feasibility of Low-Volume Interval Training (LV-ITT) and Resistance Exercise (RE) on walking performance (walking endurance, gait speed, functional balance), lower limb muscle strength and quality of life among individuals with post-stroke.', 'detailedDescription': "Prescribing aerobic and resistance training in concurrence is proposed as an optimum strategy to target cardiovascular as well as musculoskeletal functions in individuals with post-stroke. Lower limb's resistance training alone in chronic stroke produces a large effect on muscle strength. However, it has shown uncertainty results on walking performance. Therefore, it is suggested that to prescribe mix training (treadmill training and strength training) in order to improve muscle strength, gait performance and quality of life in stroke survivors. Previous studies have shown the effect of mixed training on walking performance and endurance in other populations such as multiple sclerosis and coronary artery disease. However, there is a lack of study that conducted mixed training among chronic post-stroke. Therefore, the feasibility study on the effectiveness of combining LV-ITT and RE in post-stroke should be conducted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age range between 45-65 years' old\n* At least 3-months post-stroke\n* Gait speed ≤1.0 m·s -¹ measured by the 10 m walk test.\n* Able to walk 10 m overground with assistive devices as needed and no physical assistance.\n* Able to walk for 3 min on the treadmill at ≥0.17 m·s -¹ (0.4 mph) with no aerobic exercise contraindications.\n* Modified Rankin Score (mRS) of \\<4 at the screening\n* American Heart Association class B (2), allowing for aerobic capacity \\<6 metabolic equivalent (MET)\n\nExclusion Criteria:\n\n* Significant resting ECG abnormalities\n* Hospitalization for cardiac or pulmonary disease within 3 months\n* Using Pacemaker\n* Aphasia\n* Significant musculotendinous or bony restrictions of the affected limb, or any serious chronic disease independently causing disability or profound atrophy of the affected limb that will comprise further indications to participation significant."}, 'identificationModule': {'nctId': 'NCT04623060', 'briefTitle': 'Low-Volume Interval Training and Resistance Exercise in Individual With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Teknologi Mara'}, 'officialTitle': 'Feasibility of Low-Volume Interval Training and Resistance Exercise on Walking Performance, Aerobic Fitness, Muscle Strength and Quality Of Life in Individual With Stroke', 'orgStudyIdInfo': {'id': 'REC/401/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '3 sessions/week for 6 weeks', 'interventionNames': ['Other: Combination of Low-volume interval treadmill training and Resistance Training']}], 'interventions': [{'name': 'Combination of Low-volume interval treadmill training and Resistance Training', 'type': 'OTHER', 'description': 'Low-volume interval training (LV-ITT) protocols included a 5 min warm-up (30%-50%VO2peak) up to 20min of LV-ITT and a 5 min cooling down (30%-50% VO2peak). The LV-ITT will repeat 60s bursts of fast treadmill walking at maximum tolerate speed (0% incline), alternate with pre-specified recovery periods about 4 minutes according to protocol. Each time the participants completed a burst successfully, treadmill speed will be increased by 0.1 mph for the next burst. The recovery periods will be 4 minutes. The intervention will be conducted for about 30 minutes.\n\nResistance training will be conducted by using a horizontal leg press machine. They are encouraged to focus on an explosive concentric movement and a controlled eccentric movement such that the time on each phase was in the ratio 1:2.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68100', 'city': 'Batu Caves', 'state': 'Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Nur Ainna Adanan, BSc', 'role': 'CONTACT', 'email': 'ainnaadanan@gmail.com', 'phone': '60129471427'}, {'name': 'Norliza Zainudin, MMED', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Selayang', 'geoPoint': {'lat': 3.238, 'lon': 101.682}}], 'centralContacts': [{'name': 'Nur Ainna Adanan, BSc', 'role': 'CONTACT', 'email': 'ainnaadanan@gmail.com', 'phone': '60129471427'}], 'overallOfficials': [{'name': 'Mohd Haidzir Abd Manaf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Teknologi Mara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Teknologi Mara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mohd Haidzir Abd Manaf', 'investigatorAffiliation': 'Universiti Teknologi Mara'}}}}