Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Timed Up and Go Test (TUG)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Multiple Sclerosis by a neurologist (Hacettepe University Hospitals, Neurology Outpatient Clinic)
- •Age 18 years and older
- •EDSS score between 0 and 4
- •Score of 24 or above on the Standardized Mini Mental State Examination
- •No relapse in the past 3 months
- •Medically stable for at least 6 months
排除标准
- •Any additional cardiopulmonary, neurological, or systemic disease other than MS
研究组 & 干预措施
MICT Group (Moderate-Intensity Continuous Training)
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.
干预措施: Moderate-Intensity Continuous Training (MICT) (Behavioral)
HIIT Group (High-Intensity Interval Training)
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.
干预措施: High-Intensity Interval Training (HIIT) (Behavioral)
结局指标
主要结局
Timed Up and Go Test (TUG)
时间窗: Baseline and 8 weeks
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.
次要结局
- Timed 25-Foot Walk Test (T25FW)(Baseline and 8 weeks)
- Dynamic Gait Index (DGI)(Baseline and 8 weeks)
- Incremental Shuttle Walk Test (ISWT)(Baseline and 8 weeks)
- Mini Balance Evaluation Systems Test (Mini-BESTest)(Baseline and 8 weeks)
- Modified CTSIB (mCTSIB) - Static Posturography(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)(Baseline and 8 weeks)
- California Verbal Learning Test-II (CVLT-II)(Baseline and 8 weeks)
- Brief Visuospatial Memory Test-Revised (BVMT-R)(Baseline and 8 weeks)
研究者
Kübra Turan
PhD Candidate / Physiotherapist
Hacettepe University