Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT07273058
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of HIIT on Post-Stroke Fatigue
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'The HADS consists of 14 items, divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each containing 7 items. Each item is scored on a 4-point Likert scale (0-3), resulting in subscale scores ranging from 0 to 21. Higher scores indicate greater severity of anxiety or depression.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'The PSQI is consists of 19 items grouped into seven components. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.'}, {'measure': 'Stroke Self-Efficacy Questionnaire (SSEQ)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': "The SSEQ is a 13-item self-report scale assessing stroke survivors' confidence in performing daily activities and managing post-stroke challenges. Each item is rated from 0 (not at all confident) to 4 (very confident). Total score ranges from 0 to 52. Higher scores indicate greater self-efficacy."}, {'measure': 'Fugl-Meyer Motor Assessment-Lower Extremity', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'To assess motor recovery, Fugl-Meyer Motor Assessment-Lower Extremity will be used, it score rangefrom 0 to 34; a high score is indicative of good motor recovery'}, {'measure': '6-Minute Walk Test', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'Walking endurance will be assessed using the 6-Minute Walk Test. The participants will be allowed to use assistive devices, which will be documented and kept consistent across all of the time points.'}, {'measure': 'Physical Activity Enjoyment Scale (PAES)', 'timeFrame': 'Blinded assessors will conduct evaluations at week 6 and at week 12.', 'description': "The PAES will be used to measure the participants' exercise enjoyment (score range: 0-56). A high score indicates a high level of activity enjoyment."}, {'measure': 'Behavioral Regulation In Exercise Questionnaire (BREQ-2)', 'timeFrame': 'Blinded assessors will conduct evaluations at week 1, week 12, and week 20.', 'description': 'The BREQ-2 includes 19 items. Each item is rated on a 5-point Likert scale ranging from 0 ("not true for me") to 4 ("very true for me"). Higher scores reflect higher exercise motivation.'}, {'measure': 'Mini Balance Evaluation Systems Test (MiniBEST)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'The Mini-BESTest consists of 14 items, including the Timed Up and Go test, with a maximum total score of 28 points. Higher scores indicate better balance performance.'}, {'measure': 'Short Physical Performance Battery (SPPB)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'The SPPB comprises three components: balance tests (including side-by-side, semi-tandem, and tandem stances), a gait speed test, and a five-times sit-to-stand test. Each component is scored on a scale from 0 to 4, with a total possible score ranging from 0 to 12. Higher scores indicate better physical performance.'}], 'primaryOutcomes': [{'measure': 'Eligibility rate (%)', 'timeFrame': 'Through study completion, an average of 12 weeks.'}, {'measure': 'Recruitment rate (number of participants per month)', 'timeFrame': 'Through study completion, an average of 12 weeks.'}, {'measure': 'Compliance with HIIT (%)', 'timeFrame': 'From baseline to week 12'}, {'measure': 'Fidelity to the HIIT protocol (%)', 'timeFrame': 'From baseline to week 12'}, {'measure': 'Retention of the intervention (%)', 'timeFrame': 'From baseline to week 12'}, {'measure': 'Adverse events (number of events)', 'timeFrame': 'From baseline to week 12'}, {'measure': 'Acceptability (qualitative)', 'timeFrame': 'At week 12'}], 'secondaryOutcomes': [{'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'The FSS consists of 9 items rated on a 7-point Likert scale from 1 (highly disagree) to 7 (highly agree). Higher scores indicate greater fatigue severity.'}, {'measure': 'Multidimensional Fatigue Inventory (MDI)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.', 'description': 'The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report questionnaire designed to assess fatigue across five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity. Each subscale contains 4 items rated on a 5-point Likert scale. Higher scores indicate greater fatigue. The total score ranges from 20 to 100.'}, {'measure': 'Short Form-36 Health Survey (SF-36)', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 6, and week 12.', 'description': 'The SF-36 includes 36 items and one additional item assessing perceived change in health over time. Each domain is scored on a scale from 0 to 100, with higher scores indicating better health status.'}, {'measure': 'Inflammatory biomarkers', 'timeFrame': 'Blinded assessors will conduct evaluations at baseline, week 6, and week 12.', 'description': "Inflammatory biomarkers will be quantified using enzyme-linked immunosorbent assay (ELISA) kits obtained from commercial suppliers, following the manufacturer's instructions."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of high-intensity interval training (HIIT) on fatigue severity among individuals with chronic stroke. Participants will be randomly assigned to the HIIT group, the moderate-intensity continuous training (MICT) group, or the stretching group (active control). Each group will participate in supervised exercise sessions three times per week over a 12-week period, totaling 36 sessions. Outcome assessments will be conducted at baseline, mid-intervention (week 6), post-intervention (week 12), and follow-up (week 20). The primary outcome will be fatigue severity. Secondary outcomes will include inflammatory biomarkers and additional health-related indicators.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age of 40-80 years;\n* a history of ischemic stroke resulting in unilateral limb impairment 6-60 months prior to consent to participate in the pilot trial;\n* a stable medical condition;\n* a subjective feeling of fatigue, defined as a period of apparent fatigue, decreased energy, increased need for rest, or fatigue out of proportion to physical activity for at least 2 weeks during the past month;\n* ability to communicate with the investigators and lack of significant cognitive deficits;\n* able to walk for 10 meters with or without a walking aid.\n\nExclusion criteria:\n\n* An FSS score of \\< 4 (20);\n* other neurological conditions;\n* other musculoskeletal comorbidities that would prevent safe participation in exercises;\n* a medical diagnosis of significant cardiovascular, pulmonary, or metabolic disease(s);\n* signs or symptoms indicative of significant cardiovascular, pulmonary, or metabolic disease(s) during the previous 3 months;\n* severe lower limb spasticity (Ashworth Scale score ≥ 3);\n* Botulinum toxin use in the affected lower limb within the past six months;\n* current or previous use of drugs intended to resolve post-stroke fatigue;\n* active engagement in other stroke rehabilitation trials.'}, 'identificationModule': {'nctId': 'NCT07273058', 'briefTitle': 'Effect of HIIT on Post-Stroke Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effect of High-Intensity Interval Training Intervention on Post-Stroke Fatigue in Chronic Stroke Survivors: A Pilot Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HSEARS20241002001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIIT', 'interventionNames': ['Behavioral: HIIT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MICT', 'interventionNames': ['Behavioral: MICT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching', 'interventionNames': ['Behavioral: stretching']}], 'interventions': [{'name': 'HIIT', 'type': 'BEHAVIORAL', 'description': 'The HIIT intervention will consist of a 3-minute warm-up, a 25-minute main exercise, and a 2-minute cool-down. The main exercise will include four 4-minute high-intensity intervals, each interspersed with a 3-minute low-intensity recovery period. Participants will attend three supervised sessions per week over a 12-week period.', 'armGroupLabels': ['HIIT']}, {'name': 'MICT', 'type': 'BEHAVIORAL', 'description': 'The MICT intervention will include a 3-minute warm-up, 25 minutes of continuous exercise performed at a moderate intensity, and a 2-minute cool-down. Participants will attend three supervised sessions per week over a 12-week period.', 'armGroupLabels': ['MICT']}, {'name': 'stretching', 'type': 'BEHAVIORAL', 'description': 'The stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period.', 'armGroupLabels': ['Stretching']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Meizhen Huang', 'role': 'CONTACT', 'email': 'mei-zhen.huang@polyu.edu.hk', 'phone': '+852 0000000'}], 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Mei Zhen Prof. Huang', 'role': 'CONTACT', 'email': 'mei-zhen.huang@polyu.edu.hk', 'phone': '+852 00000000'}, {'name': 'Fong Sze Chung', 'role': 'CONTACT', 'email': 'fschung@polyu.edu.hk'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Dr HUANG Mei Zhen', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}