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Effects of Low-Load Blood Flow Restriction Exercise on Rectus Femoris Muscle Morphology in Individuals With Relapsing-Remitting Multiple Sclerosis (RRMS-BFR)

2026年6月9日 更新者:Hanifi Bal

Effects of Low-Load Blood Flow Restriction Exercise on Rectus Femoris Muscle Morphology in Individuals With Relapsing-Remitting Multiple Sclerosis: A Three-Arm Randomized Controlled Trial

Multiple sclerosis (MS) is a chronic neurological disease associated with reduced muscle strength, impaired mobility, increased fatigue, and deterioration in muscle morphology. Rectus femoris muscle atrophy and reduced muscle quality have been linked to functional limitations and decreased mobility in individuals with MS.

Blood flow restriction (BFR) training is a rehabilitation strategy that combines low-load exercise with partial vascular occlusion, enabling muscular adaptations comparable to those achieved with higher exercise loads. Although BFR has demonstrated promising results in several clinical populations, evidence regarding its effects on muscle morphology in individuals with relapsing-remitting multiple sclerosis (RRMS) remains limited.

The purpose of this randomized controlled trial is to investigate the effects of low-load BFR exercise on rectus femoris muscle morphology in individuals with RRMS. Thirty participants with RRMS (EDSS 2.5-3.5) will be randomly assigned to one of three groups: a BFR exercise group, a sham-BFR exercise group, or an exercise-only control group. All participants will complete the same supervised exercise program twice weekly for eight weeks.

The primary outcome will be rectus femoris muscle thickness assessed by ultrasonography. Secondary outcomes will include rectus femoris echo intensity, knee extensor muscle strength, Timed 25-Foot Walk performance, Nine-Hole Peg Test performance, Symbol Digit Modalities Test scores, and Modified Fatigue Impact Scale scores.

This study aims to determine whether the addition of blood flow restriction to a standardized low-load exercise program results in superior morphological and functional adaptations compared with sham-BFR and exercise-only conditions in individuals with RRMS.

調査の概要

詳細な説明

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system characterized by demyelination, axonal degeneration, and progressive functional impairment. Individuals with relapsing-remitting multiple sclerosis (RRMS) frequently experience reductions in lower-extremity muscle strength, impaired walking performance, fatigue, and decreased physical function. Among lower-extremity muscles, the rectus femoris (RF) plays a critical role in knee extension, gait performance, and functional mobility. Previous studies have demonstrated associations between RF muscle morphology, muscle performance, and mobility outcomes in individuals with MS.

Blood flow restriction (BFR) exercise involves the application of external pressure to the proximal portion of a limb during low-load exercise. By partially restricting arterial inflow and substantially reducing venous return, BFR creates a hypoxic and metabolically stressful environment within the exercising muscle. This physiological stimulus promotes early recruitment of fast-twitch motor units and may enhance anabolic signaling pathways despite the use of relatively low exercise loads. Consequently, BFR has emerged as a promising rehabilitation strategy for populations that may not tolerate high-intensity resistance training.

Although preliminary evidence suggests that BFR is feasible and safe in people with MS, existing studies have primarily focused on functional outcomes, and the effects of BFR on muscle morphology remain unclear. Furthermore, no randomized controlled trial has investigated rectus femoris muscle morphology as a primary outcome using a three-arm design incorporating both sham-BFR and exercise-only control conditions.

This study is designed as a prospective, parallel-group, three-arm randomized controlled trial. Thirty individuals with RRMS aged 18-65 years and an Expanded Disability Status Scale (EDSS) score between 2.5 and 3.5 will be recruited. Participants will be randomly allocated in a 1:1:1 ratio to one of three groups:

  1. Low-load exercise with blood flow restriction (BFR).
  2. Low-load exercise with sham blood flow restriction.
  3. Low-load exercise without blood flow restriction (control).

All groups will participate in an identical supervised exercise program twice weekly for eight weeks (16 sessions total). Exercise sessions will include a standardized warm-up period, quadriceps-focused strengthening exercises, cycling exercise, and cool-down/stretching activities. The only systematic difference between groups will be the cuff condition applied during the strengthening component.

In the BFR group, individualized arterial occlusion pressure (AOP) will be determined using a pneumatic cuff system, and exercise will be performed at 50-60% of AOP. In the sham-BFR group, cuffs will be applied in the same location but inflated to a pressure insufficient to produce meaningful vascular occlusion. The control group will perform the same exercise program without cuff application.

Outcome assessments will be conducted at baseline and after completion of the intervention. The primary outcome will be rectus femoris muscle thickness measured by ultrasonography. Secondary outcomes will include rectus femoris echo intensity, knee extensor muscle strength, Timed 25-Foot Walk performance, Nine-Hole Peg Test performance, Symbol Digit Modalities Test scores, and Modified Fatigue Impact Scale scores.

The study is expected to provide novel evidence regarding the effectiveness of low-load BFR exercise for improving muscle morphology and related functional outcomes in individuals with RRMS. In addition, the inclusion of a sham-BFR condition will allow differentiation between the physiological effects of blood flow restriction and potential placebo or expectancy effects associated with cuff application.

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

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:* Age 18-65 years

  • Diagnosis of relapsing-remitting multiple sclerosis according to revised McDonald criteria
  • EDSS score between 2.5 and 3.5
  • Clinically stable disease
  • No relapse within the previous 3 months
  • No corticosteroid treatment within the previous 3 months
  • Ability to participate in exercise training
  • Written informed consent

Exclusion Criteria:* Deep vein thrombosis or pulmonary embolism history

  • Peripheral vascular disease
  • Uncontrolled hypertension
  • Severe cardiovascular disease
  • Pregnancy
  • Recent lower extremity surgery or injury
  • Musculoskeletal or neurological conditions interfering with exercise participation
  • Contraindications to blood flow restriction training
  • Participation in another structured exercise trial during the study period

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:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:BFR Exercise Group
Participants will perform a supervised low-load exercise program twice weekly for 8 weeks combined with blood flow restriction applied to both proximal thighs at 50-60% of individually determined arterial occlusion pressure during the strengthening component of the intervention.
Low-load exercise performed with individualized blood flow restriction applied to both proximal thighs using pneumatic cuffs inflated to 50-60% of arterial occlusion pressure.
Participants will perform a supervised low-load exercise program twice weekly for 8 weeks. The exercise program will include warm-up activities, quadriceps-focused strengthening exercises, cycling exercise, and cool-down activities. The same exercise program will be applied to all study groups.
偽コンパレータ:Sham BFR Group
Participants will perform the same supervised low-load exercise program twice weekly for 8 weeks. Pneumatic cuffs will be applied to both proximal thighs but inflated to a pressure insufficient to produce meaningful vascular occlusion.
Participants will perform a supervised low-load exercise program twice weekly for 8 weeks. The exercise program will include warm-up activities, quadriceps-focused strengthening exercises, cycling exercise, and cool-down activities. The same exercise program will be applied to all study groups.
Low-load exercise performed with pneumatic cuffs applied to both proximal thighs but inflated to a pressure insufficient to produce meaningful vascular occlusion.
アクティブコンパレータ:Exercise Control Group
Participants will perform the same supervised low-load exercise program twice weekly for 8 weeks without blood flow restriction.
Participants will perform a supervised low-load exercise program twice weekly for 8 weeks. The exercise program will include warm-up activities, quadriceps-focused strengthening exercises, cycling exercise, and cool-down activities. The same exercise program will be applied to all study groups.

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
Change in Rectus Femoris Muscle Thickness
時間枠:Baseline and Week 8
Rectus femoris muscle thickness will be assessed using B-mode ultrasonography. Measurements will be obtained at baseline and after the 8-week intervention period. The primary outcome will be the change in rectus femoris muscle thickness from baseline to post-intervention.
Baseline and Week 8

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • スタディディレクター:seçil özkurt, Dr.、Istinye University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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 (推定)

2026年7月1日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2027年4月1日

試験登録日

最初に提出

2026年6月9日

QC基準を満たした最初の提出物

2026年6月9日

最初の投稿 (実際)

2026年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月12日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be made publicly available because the informed consent obtained from participants does not include permission for public data sharing and institutional policies restrict release of participant-level data.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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