- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jonathan P Little, PhD
- Telefonnummer: 250-807-9876
- E-post: jonathan.little@ubc.ca
Studieorter
-
-
British Columbia
-
Kelowna, British Columbia, Kanada, V1V 1V7
- Rekrytering
- University of British Columbia Okanagan
-
Kontakt:
- Jonathan P Little, PhD
- Telefonnummer: 250-807-9876
- E-post: jonathan.little@ubc.ca
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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%. |
|
Aktiv komparator: Treadmill Walking
Treadmill walking. |
Participants will complete 32 minutes of treadmill walking at a speed and grade that elicit 40-50% heart rate reserve. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in white blood cell count before, during, and after exercise.
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in monocyte count before, during, and after exercise
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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