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This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.
Individuals with MS aged 18 and older, with an EDSS score of 0-4, no relapse in the past three months, and medically stable condition will be randomized into two groups using a sealed-envelope method. Group 1 will receive MICT on a cycle ergometer (twice weekly, 8 weeks); Group 2 will receive low-volume HIIT with the same frequency. Both groups will receive an individualized physiotherapy program after each aerobic session. Outcomes include gait (TUG, T25FW, DGI), balance (Mini-BESTest, mCTSIB), cognitive function (BICAMS: SDMT, CVLT-II, BVMT-R), exercise capacity (ISWT), and blood biomarkers (BDNF, VEGF) assessed via ELISA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MICT Group (Moderate-Intensity Continuous Training) | Active Comparator | Cycle ergometer-based MICT, twice weekly for 8 weeks, starting at 60% of peak workload, progressing to 80%. Sessions include 5-min warm-up, 20-30 min exercise, 5-min cool-down, followed by 30-min individualized physiotherapy. |
|
| HIIT Group (High-Intensity Interval Training) | Experimental | HIIT on cycle ergometer, twice weekly for 8 weeks. Protocol: 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each, followed by 5-min cool-down. Total session: ~20 min aerobic + 30-min individualized physiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-Intensity Continuous Training (MICT) | Behavioral | Cycle ergometer-based exercise, twice weekly for 8 weeks. Starting intensity at 60% of peak workload, progressing to 80%. Each session includes 5-min warm-up, 20-30 min continuous exercise, and 5-min cool-down, followed by 30-min individualized physiotherapy program. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go Test (TUG) | Timed Up and Go Test (TUG). Participants are asked to rise from a standard chair, walk 3 meters, turn around, walk back, and sit down as fast as safely possible. Measured in seconds. Lower values indicate better functional mobility and balance. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25-Foot Walk Test (T25FW) | Timed 25-Foot Walk Test (T25FW). Participants are instructed to walk 7.62 meters (25 feet) as quickly and safely as possible. Measured in seconds. Lower values indicate better walking speed. | Baseline and 8 weeks |
| Dynamic Gait Index (DGI) |
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Inclusion Criteria:
Exclusion Criteria:
• Any additional cardiopulmonary, neurological, or systemic disease other than MS
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kübra Turan, Msc, PT | Contact | +90 506 516 41 58 | kubraaturann5@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yeliz SALCI | Hacettepe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | Turkey (Türkiye) |
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|
| High-Intensity Interval Training (HIIT) | Behavioral | Cycle ergometer-based exercise, twice weekly for 8 weeks. Each session includes 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each interval, and 5-min cool-down. Total aerobic exercise duration: ~20 min, followed by 30-min individualized physiotherapy program. |
|
Dynamic Gait Index (DGI). Assesses the ability to maintain balance while walking under varied conditions across 8 tasks. Minimum score: 0, Maximum score: 24. Higher scores indicate better dynamic gait balance. |
| Baseline and 8 weeks |
| Incremental Shuttle Walk Test (ISWT) | Incremental Shuttle Walk Test (ISWT). Participants walk between two cones placed 9 meters apart at increasing speeds guided by audio signals until they can no longer maintain the required pace. Measured in meters walked. Higher values indicate better functional exercise capacity. | Baseline and 8 weeks |
| Mini Balance Evaluation Systems Test (Mini-BESTest) | Mini Balance Evaluation Systems Test (Mini BESTest). Assesses dynamic balance across 14 items in 4 subsections: anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait. Minimum score: 0, Maximum score: 28. Higher scores indicate better balance performance. | Baseline and 8 weeks |
| Modified CTSIB (mCTSIB) - Static Posturography | Modified Clinical Test of Sensory Interaction and Balance (mCTSIB). Assesses static postural stability under 4 conditions: eyes open/closed on firm and foam surfaces. Postural sway is measured in degrees per second. Lower values indicate better static balance. | Baseline and 8 weeks |
| Serum BDNF levels (ELISA) | Baseline and 8 weeks |
| Serum VEGF levels (ELISA) | Baseline and 8 weeks |
| Symbol Digit Modalities Test (SDMT) | Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses information processing speed in neurological conditions. Participants are asked to match symbols with corresponding digits within 90 seconds. Minimum score: 0, Maximum score: 110. Higher scores indicate better cognitive processing speed. | Baseline and 8 weeks |
| California Verbal Learning Test-II (CVLT-II) | Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses auditory and verbal memory. A list of 16 words across 4 categories is read aloud and recalled over 5 trials. Minimum score: 0, Maximum score: 80. Higher scores indicate better verbal learning and memory. | Baseline and 8 weeks |
| Brief Visuospatial Memory Test-Revised (BVMT-R) | Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses visuospatial memory. Six geometric figures are presented and participants are asked to reproduce them from memory. Minimum score: 0, Maximum score: 36. Higher scores indicate better visuospatial memory. | Baseline and 8 weeks |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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