BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes (BRAID)

Arab American University (Palestine)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Standard Walking Training Program; Device: BFR Cuffs for Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06290947

BFR-AE-DT2-2023-01

IRB 2022/C/20/N (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male individuals of Palestinian descent
• Aged between 40 to 65 years
• Diagnosed with Type 2 Diabetes for a duration of 2 to 10 years, with ongoing medical supervision
• Capable of understanding and following the study's instructions, programs, and protocols

Exclusion criteria

• Females, due to hormonal and metabolic differences.
• Individuals outside the 40-65 age range to minimize age-related variations in Diabetes Mellitus.
• Patients with conditions or comorbidities that impair walking or elevate the risk associated with Blood-Flow Restriction Training (BFRT).
• An Ankle Brachial Pressure Index (ABI) greater than 0.9, as values outside the normal range (0.9 to 1.4) may indicate Peripheral Arterial Disease (PAD) or Cardiovascular Disease (CVD), affecting eligibility for participation.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Blood-Flow Restriction Walk Training (BFRw)

Experimental group

Description:

Participants in this group will engage in a Blood-Flow Restriction Walk Training (BFRw) program designed to evaluate the efficacy of BFRw in enhancing insulin sensitivity and aerobic capacity. Activities: Participants will attend three weekly supervised walking sessions for eight weeks, each integrating specialized BFR cuffs calibrated to a precise pressure to restrict blood flow during exercise partially. Purpose: This arm is crucial for testing the study's primary hypothesis by measuring the intervention's effects against a control group.

Treatment:

Device: BFR Cuffs for Intervention Group

Other: Standard Walking Training Program

Control Group Walk Training

Active Comparator group

Description:

Participants in this group will engage in a conventional walking training program without applying BFR cuffs. Activities: Participants will attend three weekly supervised walking sessions for eight weeks without using BFR cuffs. Purpose: This group will serve as a benchmark to ascertain the effectiveness of the intervention, providing a baseline for the comparative analysis of the results obtained from the intervention group.

Treatment:

Other: Standard Walking Training Program