- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07928531
Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function
Impact of Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function in Adults withT2D
To conduct a randomized control trial to determine the impact of acute blood flow restriction treadmill walking on immune cell counts, function, and phenotype in adults living with type 2 diabetes.
연구 개요
상세 설명
Participants will be randomized to a regular treadmill walking condition or treadmill walking with blood flow restriction (BFR) condition. In both groups participants will complete 32 minutes of treadmill walking at a speed and grade that 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 60%. Blood samples will be obtained pre-exercise (PRE), during the final 2 minutes of the final occlusion cycle (OCC), and 3 minutes into the recovery period post-exercise (POST) to measure outcomes.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jonathan P Little, PhD
- 전화번호: 250-807-9876
- 이메일: jonathan.little@ubc.ca
연구 장소
-
-
British Columbia
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Kelowna, British Columbia, 캐나다, V1V 1V7
- 모병
- University of British Columbia Okanagan
-
연락하다:
- Jonathan P Little, PhD
- 전화번호: 250-807-9876
- 이메일: jonathan.little@ubc.ca
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged 19-64 years
- Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0%
- Completing <150 minutes of moderate-vigorous physical activity per week.
Exclusion Criteria:
- Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
- Unstable type 2 diabetes medication of the last 3 months
- Absolute contraindications to BFR (i.e., peripheral vascular disease)
- A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions
- A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis)
- Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely
- Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity
공부 계획
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 |
|---|---|
|
실험적: Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction. |
Participants will complete 32 minutes of treadmill walking at a speed and grade that elicit 40-50% heart rate reserve. 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 60%. |
|
활성 비교기: Treadmill Walking
Treadmill walking. |
Participants will complete 32 minutes of treadmill walking at a speed and grade that elicit 40-50% heart rate reserve. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in white blood cell count before, during, and after exercise.
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The white blood cell count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in monocyte count before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The monocyte count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in neutrophil count before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The neutrophil count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in eosinophil count before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The eosinophil count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD66b+ expression before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD66b+ expression will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD11b+ expression before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD11b+ expression will be measured using flow cytometer before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD63+ expression before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD63+ expression will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of classical monocytes before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of intermediate monocytes before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of intermediate monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of non-classical monocytes before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of non-classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on classical monocytes before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on intermediate monocytes before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on intermediate monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on non-classical monocytes before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on non-classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma IL-6 before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma IL-6 concentration will be measured using a multiplex assay before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma IL-10 before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma IL-10 concentration will be measured using a multiplex assay before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma TNF-α before, during, and after exercise
기간: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma TNF-α concentration will be measured using a multiplex assay before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in 4-h LPS-induced TNF-α before and after exercise
기간: Pre-exercise, immediately post-exercise
|
The LPS-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA before and after exercise. |
Pre-exercise, immediately post-exercise
|
|
Change in 4-h LPS+IL10-induced TNF-α before and after exercise
기간: Pre-exercise, immediately post-exercise
|
The LPS+IL10-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA before and after exercise. |
Pre-exercise, immediately post-exercise
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H25-02870 acute
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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