6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
2026년 6월 23일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jonathan P Little, PhD
- 전화번호: 250-807-9876
- 이메일: jonathan.little@ubc.ca
연구 장소
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British Columbia
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Kelowna, British Columbia, 캐나다, V1V 1V7
- 모병
- University of British Columbia Okanagan
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연락하다:
- Jonathan P Little, PhD
- 전화번호: 250-807-9876
- 이메일: jonathan.little@ubc.ca
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks.
|
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.
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활성 비교기: Treadmill Walking
Treadmill walking performed 3 days per week for 6 weeks.
|
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
기간: 0-6 weeks
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T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in CD4 expression before and after the 6-week intervention
기간: 0-6 weeks
|
The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in CD8 expression before and after the 6-week intervention
기간: 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.
|
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Change in % of T regulatory cells before and after the 6-week intervention
기간: 0-6 weeks
|
The % T regulatory cells will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in % of Th1 cells before and after the 6-week intervention
기간: 0-6 weeks
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The % Th1 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in % of Th2 cells before and after the 6-week intervention
기간: The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
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The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
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Change in % of Th17 cells before and after the 6-week intervention
기간: 0-6 weeks
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The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in CD66b+ expression before and after the 6-week intervention
기간: The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
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The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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Change in CD11b+ expression before and after the 6-week intervention
기간: The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
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The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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Change in CD63+ expression before and after the 6-week intervention
기간: 0-6 weeks
|
The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in % of classical monocytes before and after the 6-week intervention
기간: 0-6 weeks
|
The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in % of intermediate monocytes before and after the 6-week intervention
기간: 0-6 weeks
|
The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in % of non-classical monocytes before and after the 6-week intervention
기간: 0-6 weeks
|
The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in TLR-4 expression on classical monocytes before and after the 6-week intervention
기간: 0-6 weeks
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The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
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Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention
기간: 0-6 weeks
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The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention
기간: 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.
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0-6 weeks
|
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Change in white blood cell count before and after the 6-week intervention
기간: 0-6 weeks
|
The white blood cell count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in monocyte count before and after the 6-week intervention
기간: 0-6 weeks
|
The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in neutrophil count before and after the 6-week intervention
기간: 0-6 weeks
|
The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in eosinophil count before and after the 6-week intervention
기간: 0-6 weeks
|
The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in plasma IL-6 before and after the 6-week intervention
기간: 0-6 weeks
|
The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in plasma IL-10 before and after the 6-week intervention
기간: 0-6 weeks
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The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in plasma TNF-α before and after the 6-week intervention
기간: 0-6 weeks
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The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in 4-h LPS-induced TNF-α before and after the 6-week intervention
기간: 0-6 weeks
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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.
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0-6 weeks
|
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Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention
기간: 0-6 weeks
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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.
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0-6 weeks
|
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Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention
기간: 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.
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0-6 weeks
|
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Change in PMA/Ionomysin induced INF-γ before and after the 6-week
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 11일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 23일
QC 기준을 충족하는 최초 제출
2026년 6월 23일
처음 게시됨 (실제)
2026년 6월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 23일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H25-02870-chronic
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .