Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:23 PM
Study NCT ID:
NCT07456956
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and care providers will not be blinded due to the nature of the exercise interventions. However, the outcomes assessor conducting the evaluations will be blinded to group allocation. Participants will be instructed not to disclose their assigned intervention to the assessor.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1 ratio to either the HIIT group or the MCIT group. Both groups will receive their respective exercise interventions in parallel over a 6-week period.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-22', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quadriceps muscle thickness measured by ultrasonography', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Quadriceps muscle thickness (rectus femoris and vastus intermedius) will be measured bilaterally using ultrasound imaging. The primary endpoint will be the change from baseline to post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Handgrip strength', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Handgrip strength will be measured using a Jamar dynamometer. The outcome will be the change from baseline to post-intervention (highest value of three trials will be used).'}, {'measure': 'Six-Minute Walk Test distance', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Functional capacity will be assessed using the Six-Minute Walk Test. The outcome will be the change in walking distance (meters) from baseline to post-intervention.'}, {'measure': 'Fugl-Meyer Assessment Lower Extremity score', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Lower extremity motor function will be assessed using the Fugl-Meyer Assessment (Lower Extremity), which ranges from 0 to 34, with higher scores indicating better motor function.'}, {'measure': 'Functional Independence Measure (FIM) score', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Functional status and independence in activities of daily living will be assessed using the Functional Independence Measure (FIM), which ranges from 18 to 126, with higher scores indicating greater independence (better functional outcome).'}, {'measure': 'SF-36 quality of life score', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Health-related quality of life will be assessed using the Short Form-36 (SF-36), with domain and/or summary scores transformed to a 0 to 100 scale, where higher scores indicate better health-related quality of life.'}, {'measure': '30-Second Sit-to-Stand Test repetitions', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Lower extremity muscle endurance will be assessed using the 30-Second Sit-to-Stand Test. The outcome will be the change in the number of completed repetitions from baseline to post-intervention.'}, {'measure': 'International Physical Activity Questionnaire (IPAQ) score', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ), reported as MET-minutes/week (range: 0 to no fixed upper limit), with higher values indicating greater levels of physical activity (better outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Stroke-Related Sarcopenia', 'HIIT', 'MCIT', 'Exercise Training', 'Muscle Thickness'], 'conditions': ['Stroke, Ischemic', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of post-stroke sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) exercise programs on muscle mass, as well as on functional capacity, quality of life, and clinical outcomes.', 'detailedDescription': 'Sarcopenia is a skeletal muscle disease characterized by progressive and generalized loss of muscle mass, muscle strength, and physical performance, and is associated with an increased risk of falls, fractures, functional dependency, and mortality. Although aging is one of the most important causes of sarcopenia, factors such as acute and chronic diseases, physical inactivity, inflammation, and malnutrition also play a critical role in its development.\n\nStroke is one of the leading causes of mortality and long-term disability worldwide, and muscle loss occurring in the post-stroke period negatively affects the functional recovery process of patients. The loss of muscle mass and muscle strength that develops after stroke is not limited to the paretic extremity; significant muscle atrophy can also be observed on the non-paretic side. This condition is defined in the literature as "stroke-related sarcopenia".\n\nStroke-related sarcopenia arises through multifactorial mechanisms such as changes in muscle fiber type, motor unit loss, decreased neuromuscular activation, increased inflammatory response, and physical inactivity. Studies have shown that there is a marked reduction in motor unit number in the early period after stroke, and that this condition is associated with loss of muscle strength. In addition, it has been reported that post-stroke sarcopenia has negative effects on activities of daily living, walking capacity, and quality of life.\n\nExercise is considered one of the most effective interventions for the prevention and treatment of sarcopenia. The positive effects of aerobic and resistance exercises on muscle mass and functional performance have been demonstrated in many studies. In recent years, the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) approaches on the cardiovascular and musculoskeletal systems have been increasingly investigated.\n\nHIIT is an exercise model in which short periods of high-intensity exercise are alternated with low-intensity recovery periods and is notable for providing high physiological adaptation within a limited time. MCIT, on the other hand, is an exercise approach performed at a longer duration and at a constant intensity. Although both exercise methods have been reported to be safe and feasible in stroke rehabilitation, data regarding their comparative effects on post-stroke sarcopenia are limited.\n\nIn the literature, the number of randomized controlled trials evaluating changes in muscle structure during the stroke rehabilitation process using objective measurement methods such as muscle ultrasonography is quite limited. Therefore, investigating the effects of different exercise approaches applied in the post-stroke period on sarcopenia, functional capacity, and clinical outcomes is important for both clinical practice and the planning of rehabilitation programs.\n\nThis study aims to investigate the effect of sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of HIIT and MCIT exercise programs on muscle mass, as well as on functional and clinical parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-ever stroke.\n* Age 18 years or older.\n* Diagnosis of ischemic stroke.\n* Stroke duration between 1-6 months (subacute phase).\n* Modified Rankin Scale score \\< 3.\n* Mini-Mental State Examination (MMSE) score ≥ 24.\n* Brunnstrom lower extremity motor stage between Stage III-V.\n* Lower extremity functional capacity sufficient to allow exercise participation (able to ambulate at least with an assistive device).\n* Lower extremity spasticity ≤ 2 according to the Modified Ashworth Scale.\n* Independent sitting balance (able to sit unsupported for at least 30 seconds).\n* Presence of sufficient voluntary active movement in the lower extremity to permit exercise application.\n* Ability to communicate.\n* Willingness to participate in the study and provision of written informed consent.\n\nExclusion Criteria:\n\n* Presence of hemispatial neglect.\n* History of recurrent stroke.\n* Presence of a psychiatric disorder.\n* Presence of orthopedic, neurological, or cardiopulmonary conditions that would contraindicate the planned exercise protocols.'}, 'identificationModule': {'nctId': 'NCT07456956', 'briefTitle': 'HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Fenerbahce University'}, 'officialTitle': 'The Effect of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training on Sarcopenia and Clinical Outcomes in Patients With Ischemic Stroke: A Single-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FenerbahceUni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Intensity Interval Training (HIIT)', 'description': 'Participants assigned to the HIIT group will perform High-Intensity Interval Training on a cycle ergometer. The protocol consists of a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by five cycles of 1 minute at 80% HRmax and 2 minutes of active recovery at 60% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be conducted three times per week for 6 weeks. Exercise intensity will be progressively increased by 5% every two weeks. All sessions will be supervised by a physiotherapist.', 'interventionNames': ['Behavioral: High-Intensity Interval Training (HIIT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate-Intensity Continuous Training (MCIT)', 'description': 'Participants assigned to the MCIT group will perform Moderate-Intensity Continuous Training on a cycle ergometer. The protocol consists of a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by 20 minutes of continuous exercise at 80% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be conducted three times per week for 6 weeks. Exercise intensity will be progressively increased by 5% every two weeks. All sessions will be supervised by a physiotherapist.', 'interventionNames': ['Behavioral: Moderate-Intensity Continuous Training (MCIT)']}], 'interventions': [{'name': 'High-Intensity Interval Training (HIIT)', 'type': 'BEHAVIORAL', 'otherNames': ['HIIT'], 'description': 'High-Intensity Interval Training (HIIT) will be delivered on a cycle ergometer under physiotherapist supervision. Each session includes a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by five cycles of 1 minute at 80% HRmax and 2 minutes of active recovery at 60% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be performed 3 times per week for 6 weeks, with intensity progressed by 5% every two weeks as tolerated.', 'armGroupLabels': ['High-Intensity Interval Training (HIIT)']}, {'name': 'Moderate-Intensity Continuous Training (MCIT)', 'type': 'BEHAVIORAL', 'otherNames': ['MCIT'], 'description': 'Moderate-Intensity Continuous Training (MCIT) will be delivered on a cycle ergometer under physiotherapist supervision. Each session includes a 5-minute warm-up at 50% of maximum heart rate (HRmax), followed by 20 minutes of continuous exercise at 80% HRmax, and a 5-minute cool-down at 50% HRmax. Sessions will be performed 3 times per week for 6 weeks, with intensity progressed by 5% every two weeks as tolerated.', 'armGroupLabels': ['Moderate-Intensity Continuous Training (MCIT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34758', 'city': 'Istanbul', 'state': 'Ataşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sümeyye Akçay, Asst. Prof.', 'role': 'CONTACT', 'email': 'smyye.akcy@gmail.com', 'phone': '+905424002553'}], 'facility': 'Fenerbahçe University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Sümeyye Akçay, Asst. Prof.', 'role': 'CONTACT', 'email': 'smyye.akcy@gmail.com', 'phone': '+905424002553'}], 'overallOfficials': [{'name': 'Sümeyye Akçay, Asst. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fenerbahçe University'}, {'name': 'Arzu Dinç Yavaş, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istanbul Aydın University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fenerbahce University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Sümeyye Akçay', 'investigatorAffiliation': 'Fenerbahce University'}}}}