- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07578740
The Effects of High-Intensity Interval Training on Gait, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis (HIIT-MS)
Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kübra Turan, Msc, PT
- 전화번호: +90 506 516 41 58
- 이메일: kubraaturann5@gmail.com
연구 장소
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Ankara, 터키 (Türkiye)
- Hacettepe University
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연락하다:
- Kübra Turan
- 전화번호: +90 506 516 41 58
- 이메일: kubraaturann5@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
• Any additional cardiopulmonary, neurological, or systemic disease other than MS
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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. |
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. |
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실험적: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Timed Up and Go Test (TUG)
기간: Baseline and 8 weeks
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum BDNF levels (ELISA)
기간: Baseline and 8 weeks
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Baseline and 8 weeks
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Serum VEGF levels (ELISA)
기간: Baseline and 8 weeks
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Baseline and 8 weeks
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Timed 25-Foot Walk Test (T25FW)
기간: Baseline and 8 weeks
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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
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Dynamic Gait Index (DGI)
기간: Baseline and 8 weeks
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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
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Incremental Shuttle Walk Test (ISWT)
기간: Baseline and 8 weeks
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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
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Mini Balance Evaluation Systems Test (Mini-BESTest)
기간: Baseline and 8 weeks
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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
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Modified CTSIB (mCTSIB) - Static Posturography
기간: Baseline and 8 weeks
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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
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Symbol Digit Modalities Test (SDMT)
기간: Baseline and 8 weeks
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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
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California Verbal Learning Test-II (CVLT-II)
기간: Baseline and 8 weeks
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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
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Brief Visuospatial Memory Test-Revised (BVMT-R)
기간: Baseline and 8 weeks
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yeliz SALCI, Hacettepe University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FTREK26/19
개별 참가자 데이터(IPD) 계획
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