The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Blood flow restriction training (BFRT) combined with resistance or aerobic exercise has been
      shown to improve the glucose uptake in humans. In addition, BFRT represents a low-load,
      alternative exercise program for type 2 diabetes patients who often have reduced physical
      fitness. However, it is not clear to what extent could BFRT improve glycemic control among
      patients with type 2 diabetes. This pilot randomized-controlled trial aims to investigate the
      effect of a 12-week, low-intensity BFRT on glycemic control among patients with type 2
      diabetes, compared to medium-high intensity aerobic exercise or low-intensity exercise
      without BFRT.
    

Detailed description: 
      Objectives:

      The pilot randomized study aims to explore the effects of blood flow restriction combined
      with aerobic training (BFRT) on the glucose and lipid metabolism indexes and vascular
      endothelial factors of type 2 diabetes, by comparing it with traditional low-intensity and
      high-intensity aerobic training. It aims to evaluate the effectiveness of BFRT in glycemic
      control of type 2 diabetes patients.

      Study Population:

      A total of 60 patients with type 2 diabetes who are 50-65 years old at the Maigaoqiao
      Community Health Service Center, Qixia District, Nanjing, China, with a course of type 2
      diabetes of 2-10 years will be included as the participants.

      Randomization:

      Participants will be stratified by baseline hemoglobin A1c (HbA1c) and age, they will be
      randomly assigned into three groups with a block size of six. The study groups are: 1)
      low-intensity training combined with blood flow restriction group (LI-BFR group, 40% heart
      rate reserve combined with 50% arterial occlusion pressure, n=20) 2)high-intensity aerobic
      exercise group (HI group, 70% heart rate reserve, n=20) 3) Low-intensity group (LI group, 40%
      heart rate reserve, n=20).
    

Intervention name(s): Low-intensity training combined with blood flow restriction (LI-BFR); High-intensity aerobic exercise (HI); Low intensity exercise (LI)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve), with compression belts attached on both thighs, during exercise the belts are inflated with 50% of the participant's arterial occlusion pressure. Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. The compression belt is deflated during the rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.; Participants (n=20) receives high intensity aerobic exercise intervention on a cycle ergometer (at 70% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.; Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: blood flow restriction training; type 2 diabetes; aerobic exercise; randomized-controlled trial