Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290947
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2024-02-21
Brief Title:
BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes
Sponsor:
Arab American University Palestine
Organization:
Arab American University Palestine
Study Overview
Official Title:
Evaluating the Impact of Blood-Flow Restriction Walk Training on Insulin Sensitivity and Aerobic Capacity in Individuals With Type 2 Diabetes Mellitus A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAID
Brief Summary:
This clinical trial examines the impact of Blood-Flow Restriction Walk Training BFRw on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes T2D
The primary objectives of the study are to determine If Blood-Flow Restriction Walk Training BFRw can improve insulin sensitivity in individuals with Type 2 Diabetes T2D
Whether Blood-Flow Restriction Walk Training BFRw enhances aerobic capacity in individuals with Type 2 Diabetes T2D
Participants in the study are divided into two groups One group undergoes Blood-Flow Restriction Walk Training BFRw and the other serves as a control Both groups attend three treadmill walking sessions weekly for eight weeks The BFRw group has a restriction cuff placed around both thighs during their sessions while the control group participates in the walking sessions without any blood flow restriction
Hemoglobin A1c HbA1c levels and maximal oxygen consumption VO2 max are monitored as indicators of insulin sensitivity and aerobic capacity respectively
The primary objectives of the study are to determine If Blood-Flow Restriction Walk Training BFRw can improve insulin sensitivity in individuals with Type 2 Diabetes T2D
Whether Blood-Flow Restriction Walk Training BFRw enhances aerobic capacity in individuals with Type 2 Diabetes T2D
Participants in the study are divided into two groups One group undergoes Blood-Flow Restriction Walk Training BFRw and the other serves as a control Both groups attend three treadmill walking sessions weekly for eight weeks The BFRw group has a restriction cuff placed around both thighs during their sessions while the control group participates in the walking sessions without any blood flow restriction
Hemoglobin A1c HbA1c levels and maximal oxygen consumption VO2 max are monitored as indicators of insulin sensitivity and aerobic capacity respectively
Detailed Description:
In this clinical trial the efficacy of Blood-Flow Restriction Walk Training BFRw as a therapeutic modality to enhance insulin sensitivity and aerobic capacity is meticulously explored among individuals diagnosed with Type 2 Diabetes This innovative approach combines the simplicity of low-intensity walking exercises with the physiological benefits of blood-flow restriction applied to the lower extremities proposing that such a combination can induce muscle adaptations typically associated with high-intensity resistance training
The study is centered around a rigorously structured protocol in which participants assigned to the intervention arm undergo supervised BFRw sessions These sessions are carefully calibrated to ensure a balance between safety and effectiveness with a focus on gradually increasing the intensity and duration of the exercise to accommodate the varying fitness levels of participants and to mitigate any potential risks associated with blood-flow restriction techniques
The research primarily investigates the hypothesis that BFRw can lead to significant improvements in metabolic health markers and physical performance metrics without the physical strain associated with traditional high-intensity exercise regimes By examining the incremental adaptation of skeletal muscle under conditions of reduced oxygen supply the study aims to uncover the mechanisms through which BFRw supports enhancements in glucose metabolism and cardiovascular fitness
Furthermore the study seeks to identify the optimal parameters for blood-flow restriction that maximize therapeutic benefits while minimizing discomfort and potential complications This involves comprehensive assessments of insulin sensitivity via glucose tolerance tests and insulin assays and aerobic capacity measured through graded exercise testing to determine VO2 max
This investigation is designed to provide valuable insights into the feasibility safety and efficacy of incorporating Blood-Flow Restriction Walk Training into the treatment regimen for Type 2 Diabetes By redefining exercise recommendations for individuals with limited tolerance for traditional high-intensity workouts the research could significantly impact future guidelines and practices for managing this prevalent metabolic disorder
The study is centered around a rigorously structured protocol in which participants assigned to the intervention arm undergo supervised BFRw sessions These sessions are carefully calibrated to ensure a balance between safety and effectiveness with a focus on gradually increasing the intensity and duration of the exercise to accommodate the varying fitness levels of participants and to mitigate any potential risks associated with blood-flow restriction techniques
The research primarily investigates the hypothesis that BFRw can lead to significant improvements in metabolic health markers and physical performance metrics without the physical strain associated with traditional high-intensity exercise regimes By examining the incremental adaptation of skeletal muscle under conditions of reduced oxygen supply the study aims to uncover the mechanisms through which BFRw supports enhancements in glucose metabolism and cardiovascular fitness
Furthermore the study seeks to identify the optimal parameters for blood-flow restriction that maximize therapeutic benefits while minimizing discomfort and potential complications This involves comprehensive assessments of insulin sensitivity via glucose tolerance tests and insulin assays and aerobic capacity measured through graded exercise testing to determine VO2 max
This investigation is designed to provide valuable insights into the feasibility safety and efficacy of incorporating Blood-Flow Restriction Walk Training into the treatment regimen for Type 2 Diabetes By redefining exercise recommendations for individuals with limited tolerance for traditional high-intensity workouts the research could significantly impact future guidelines and practices for managing this prevalent metabolic disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 2022C20N | OTHER_GRANT | AAUP | None |