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临床试验/NCT06290947
NCT06290947已完成不适用

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

Arab American University (Palestine)2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2022年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Improvement in Aerobic Capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

None (Open Label)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Improvement in Aerobic Capacity

时间窗: 8 weeks

This outcome measure will evaluate the change in aerobic capacity as indicated by VO2 max (maximal oxygen consumption) levels. This assessment will determine the effectiveness of Blood-Flow Restriction Walk Training in enhancing aerobic efficiency in participants.

Improvement in Insulin Sensitivity

时间窗: 8 weeks

This measure assesses the change in insulin sensitivity determined by cumulative sugar measure.

次要结局

  • Change in Body Mass Index (BMI)(8 weeks)

研究者

发起方
Arab American University (Palestine)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samer AbuEid

Assistant Professor

Arab American University (Palestine)

研究点 (2)

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