High-Intensity Interval Training for Walking and Function Across Different Multiple Sclerosis Disability Levels
2026年9月7日 更新者：ISMAIL KARA、Hacettepe University
The Effect of High-Intensity Interval Training on Maximum Walking Distance and Functional Parameters in Patients With Multiple Sclerosis at Different Disability Levels
Multiple Sclerosis (MS) is a chronic neurological disease that can affect daily functioning, mobility, and overall quality of life. High-Intensity Interval Training (HIIT) is known to be a time-efficient exercise approach that improves exercise capacity and reduces fatigue in MS. However, current research lacks sufficient data on how HIIT affects individuals with different levels of disability.
The main purpose of this study is to evaluate the effects of a stationary bicycle-based HIIT protocol on maximum walking distance, fatigue, balance, muscle strength, endurance, gait speed, and quality of life in MS patients across three different disability levels: mild, moderate, and severe (classified according to Expanded Disability Status Scale - EDSS scores).
Participants will complete a cycle ergometer-based HIIT program. Assessments will be conducted at three time points:
Before starting the exercise program (baseline)
Immediately after completing the program (post-treatment)
4 weeks after the completion of the program (follow-up)
To ensure unbiased results, a triple-blind design will be used, meaning the outcome assessor, the treating physiotherapist, and the data analyst will be blinded to group assignments. The findings aim to help clinicians tailor personalized, effective HIIT protocols based on a patient's specific disability level rather than using a standardized, one-size-fits-all approach in MS rehabilitation.
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：İSMAİL KARA, MSc
- 電話番号：+90 553 525 8700
- メール：ismailkaraa46@gmail.com
研究場所
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Hatay、トルコ（Türkiye）
- 募集
- Hatay Mustafa Kemal Universty
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コンタクト：
- Yasemin Karaaslan, Phd
- メール：ptyasemindeveci@gmail.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Be between the ages of 18 and 65,
- Have been diagnosed with MS by a treating physician,
- Have an EDSS score between 0 and 6.5,
- Not having experienced a relapse within the last 3 months,
- Not having severe lower extremity contractures, severe spasticity (≥3 on the Modified Ashworth Scale), or an acute orthopedic problem that would prevent the participant from pedaling on a bicycle ergometer,
- Having a Mini Mental State Examination score of ≥24.
Exclusion Criteria:
- Having a severe cardiovascular, orthopedic, respiratory, or metabolic disease,
- Having an additional neurological condition,
- Being pregnant or suspecting pregnancy,
- Having received a botulinum toxin injection within the last 3 months,
- Having a COMPASS-31 total score greater than 13.6
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Mild Disability Group (EDSS 0 to <=2.5)
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All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden).
The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate.
Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate.
The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end.
Sessions will be conducted three times a week.
The total treatment duration is planned to be 8 weeks.
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実験的：Moderate Disability Group (EDSS 3.0 to <=4.5)
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All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden).
The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate.
Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate.
The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end.
Sessions will be conducted three times a week.
The total treatment duration is planned to be 8 weeks.
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実験的：Severe Disability Group (EDSS 5.0 to <=6.5)
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All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden).
The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate.
Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate.
The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end.
Sessions will be conducted three times a week.
The total treatment duration is planned to be 8 weeks.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maximum Walking Distance
時間枠：Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)
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Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.
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Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fatigue
時間枠：Baseline, immediately post-intervention, and 4 weeks follow-up
|
Fatigue will be evaluated with the Fatigue Severity Scale.
This scale also assesses the fatigue severity of patients through 9 questions.
Each question has a score ranging from 1 (strongly disagree) to 7 (strongly agree).
The fatigue severity scale score is determined by calculating the average value of the responses given to these 9 questions.
A higher score indicates greater fatigue severity.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Muscle Strength
時間枠：Baseline, immediately post-intervention, and 4 weeks follow-up
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It will be evaluated using a hand-held dynamometer.
In this test, which will be performed in a long-sitting position with the hips in 90 degrees of flexion and the knees in extension, the measuring device (Lafayette Instrument Company, Lafayette IN, USA) will be placed on the sole of the foot.
The patient will then be asked to press their foot downward, and the result will be recorded.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Muscular Endurance
時間枠：Baseline, immediately post-intervention, and 4 weeks follow-up
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It will be evaluated through repetitive muscle contraction tests.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Gait Speed
時間枠：Baseline, immediately post-intervention, and 4 weeks follow-up
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The walking speeds of the participants will be evaluated using the 10-Meter Walk Test, whose validity and reliability have been proven in clinical studies.
During the assessment, participants will be asked to walk along a 10-meter straight and obstacle-free corridor at their normal pace, and the elapsed time will be recorded using a stopwatch.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Health-Related Quality of Life
時間枠：Baseline, immediately post-intervention, and 4 weeks follow-up
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It will be evaluated using the Multiple Sclerosis Impact Scale-29.
The questionnaire assesses the impact of MS on daily life over the past two weeks.
Responses are recorded on a 5-point Likert scale ranging from 1 ("not at all") to 5 ("extremely").
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Baseline, immediately post-intervention, and 4 weeks follow-up
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balance
時間枠：Baseline, immediately post-intervention, and 4 weeks follow-up
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Objective balance assessments of the participants will be performed using the TecnoBody PK200 Balance Device.
As part of the assessment protocol, patients will sequentially undergo stabilometric static balance, the Romberg test in eyes-open and eyes-closed positions, single-leg stance on the right and left, and dynamic balance tests.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Dynamic Balance
時間枠：Baseline, immediately post-intervention, and 4 weeks follow-up
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It will be evaluated using the Community Balance and Mobility Scale.
This scale evaluates balance and mobility status across 13 tasks that involve advanced functional balance and mobility activities.
Each item is scored between 0 and 5 (0 = unable to perform, 5 = able to perform independently).
Item 12 is scored from 0 to 6, with an additional point added if a basket is carried while descending the stairs.
Higher scores indicate better balance and mobility.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年9月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2028年1月31日
試験登録日
最初に提出
2026年8月4日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Hacettepe-PT-MS-01
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いいえ
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