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6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics

2026年6月23日 更新者：Jonathan Little、University of British Columbia

Impact of 6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics in Adults withT2D

To conduct a randomized control trial to determine the impact of 6-weeks of blood flow restriction training on immune cell function and bioenergetics in adults living with type 2 diabetes.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Participants will be randomized to a regular treadmill walking group or treadmill walking with blood flow restriction (BFR) group for 6 weeks. In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During week 1 participants will walk for 21 minutes during each session which will be increased to 32 minutes for the remaining 5 weeks of the study. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 minute every 10 minutes based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively. All outcomes will be assessed at baseline before randomization and at the end of the 6-week intervention.

研究の種類

介入

入学 (推定)

20

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

研究場所

  • カナダ
    • British Columbia
      • Kelowna、British Columbia、カナダ、V1V 1V7
        • 募集
        • University of British Columbia Okanagan
        • コンタクト：

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

A. Aged 19-64 years. B. Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0% C. Completing <150 minutes of moderate-vigorous physical activity per week.

Exclusion Criteria:

A. Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.

B. Unstable type 2 diabetes medication of the last 3 months C. Absolute contraindications to BFR (i.e., peripheral vascular disease) D. A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions E. A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis) F. Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely G. Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity

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：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks.
他の：Exercise
In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.
アクティブコンパレータ：Treadmill Walking
Treadmill walking performed 3 days per week for 6 weeks.
他の：Exercise
In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.

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 T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
時間枠：0-6 weeks
T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.
0-6 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in CD4 expression before and after the 6-week intervention
時間枠：0-6 weeks
The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in CD8 expression before and after the 6-week intervention
時間枠：The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in % of T regulatory cells before and after the 6-week intervention
時間枠：0-6 weeks
The % T regulatory cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of Th1 cells before and after the 6-week intervention
時間枠：0-6 weeks
The % Th1 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of Th2 cells before and after the 6-week intervention
時間枠：The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in % of Th17 cells before and after the 6-week intervention
時間枠：0-6 weeks
The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in CD66b+ expression before and after the 6-week intervention
時間枠：The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in CD11b+ expression before and after the 6-week intervention
時間枠：The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in CD63+ expression before and after the 6-week intervention
時間枠：0-6 weeks
The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of classical monocytes before and after the 6-week intervention
時間枠：0-6 weeks
The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of intermediate monocytes before and after the 6-week intervention
時間枠：0-6 weeks
The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of non-classical monocytes before and after the 6-week intervention
時間枠：0-6 weeks
The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in TLR-4 expression on classical monocytes before and after the 6-week intervention
時間枠：0-6 weeks
The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention
時間枠：0-6 weeks
The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention
時間枠：0-6 weeks
The TLR-4 expression on non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in white blood cell count before and after the 6-week intervention
時間枠：0-6 weeks
The white blood cell count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in monocyte count before and after the 6-week intervention
時間枠：0-6 weeks
The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in neutrophil count before and after the 6-week intervention
時間枠：0-6 weeks
The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in eosinophil count before and after the 6-week intervention
時間枠：0-6 weeks
The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in plasma IL-6 before and after the 6-week intervention
時間枠：0-6 weeks
The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
0-6 weeks
Change in plasma IL-10 before and after the 6-week intervention
時間枠：0-6 weeks
The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
0-6 weeks
Change in plasma TNF-α before and after the 6-week intervention
時間枠：0-6 weeks
The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
0-6 weeks
Change in 4-h LPS-induced TNF-α before and after the 6-week intervention
時間枠：0-6 weeks
The LPS-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks
Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention
時間枠：0-6 weeks
The LPS+IL10-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks
Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention
時間枠：0-6 weeks
The CD3/CD28 stimulated INF-γ concentration will be measured from T-cell culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks
Change in PMA/Ionomysin induced INF-γ before and after the 6-week
時間枠：0-6 weeks
The PMA/Ionomysin induced INF-γ concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks

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

University of British Columbia

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2月11日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年6月23日

QC基準を満たした最初の提出物

2026年6月23日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月30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23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

追加の関連 MeSH 用語

その他の研究ID番号

  • H25-02870-chronic

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?

未定

医薬品およびデバイス情報、研究文書

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

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