The Impact of Blood Flow Restriction Training Combined with Low to Moderate Intensity Exercise versus Traditional Exercise on Glycemic Control in Individuals with Type 2 Diabetes Mellitus.”– An Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin (HbA1c), Fasting Blood Sugar( FBS)
研究概览
简要总结
A experimental trialis planned to be conducted at the Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University). An informed consent will be obtained from the study population. The Individuals glycemic levels, quality of life and muscle strength are to be measured, using HbA1c, QoL-Q Diabetes and Hand-Held Dynamometer respectively. The study population will be allocated into two groups, the experimental group and the control group. The experimental group will undergo BFRT with low to moderate intensity exercise whereas the control group will undergo same exercise regimen without the application of BFRT. The intervention will run for eight weeks with outcome measures assessed both at baseline (pre-intervention) and after completion of the exercise program (post-intervention). The participants in the experimental group will be made to perform Blood Flow Restriction training BFRT that will target the upper limbs using compound resitstance exercises such as seated rows, upright rows and shoulder presses while a BFRT cuff inflated to 40% of arterial occlusion pressure (AOP) is applied over the proximal portion of both upper arms. The exercise performed will consist of 3 sets of 30 seconds (continuos repititions) with rests between each set of 30 seconds. The cuff will remain inflated for the entireity of the exercise, The total occlusion time per exercise will be 3 minutes and after completion of 3 sets in an exercise, the cuffs will be deflated and participants will be allowed to rest for 1-3 minutes to allow for vascular reperfusion before proceeding to the next exercise. AOP will be measured for each individual using either Doppler Ultrasound or standardized palpatory methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •The study includes individuals with type 2 diabetes mellitus, both males and females, aged between 18 and 55 years.
- •Participants must have provided consent and have a glycated hemoglobin (HbA1c) level between 7 and 10.
排除标准
- •Individuals with a history of certain medical conditions are excluded, including cerebrovascular accident (CVA), chronic kidney disease (CKD), coronary artery disease (CAD), heart failure, and uncontrolled hypertension.
- •Additionally, those with musculoskeletal impairment, peripheral vascular disease (PVD), deep vein thrombosis (DVT), or thromboembolic events are not eligible.
- •Patients with severe neuropathy, sensory deficits, open wounds, skin infections, or compromised skin integrity in the limb undergoing blood flow restriction training (BFRT) are also excluded.
结局指标
主要结局
Glycated Hemoglobin (HbA1c), Fasting Blood Sugar( FBS)
时间窗: Baseline (Pre-intervention) | 8 Weeks (Post-intervention)
次要结局
- Handgrip Strength (HGS)(Diabetes-Specific Quality of Life Questionnaire (DM-QOL))
研究者
Alex Collins Mathew
Sri Ramachandra Institute Of Higher Education and Research (DU)
