跳至主要内容
临床试验/NCT05411640
NCT05411640已完成不适用

Effect of Blood Flow Restriction Training on Glycemic Control, Functional Activity and Quality of Life in Individuals With Prediabetes

Riphah International University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Hemoglobin A1c (HbA1c) test

研究概览

简要总结

The aim of this study is to determine the effects of blood flow restriction training on glycemic control and functional activity in participants with prediabetes. Moreover, This study determine the effects of blood flow restriction training on quality of life in participants with prediabetes

详细描述

In 2021, a randomized control trial had been conducted to determine the effects of two methods of resistance training with and without blood flow restriction on coagulation indices and blood glucose levels in type 2 diabetic patients. This study recruited 41 patients with type 2 diabetes were randomly divided into three groups of resistance training with and without blood flow restriction and the control group. The subjects of the resistance training group with and without flow restriction performed the training for 8 weeks with intensities of 20, 40, 60, 80% of one maximum repetition and 20 and 30% of one maximum repetition, respectively. During this period, the subjects in the control group led a normal life and did not have a regular exercise program. Coagulation parameters, hematocrit and blood glucose levels were measured before and 48 hours after the last training session. This study concluded that 8 weeks of resistance training can prevent thrombosis and sudden onset of cardiovascular disease in patients with type 2 diabetes by reducing fibrinogen levels and increasing the Prothrombin Time index. This type of exercise also plays an insulin-like role by lowering blood sugar levels.

In 2019, a randomized control trial had been conducted to determine the Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities. This study included 26 patients, providing 16 Blood Flow Restriction and 10 control patients. Patients were excluded for cardiac, pulmonary, or hematologic disease; pregnancy; or previous surgery in the extremity. The experimental group completed a standardized 6-week course of Blood Flow Restriction training. All participants of experimental group completed the following exercises at each training session: straight-leg raise hip flexion, side-lying hip abduction, long-arc quadriceps extension, and standing hamstring curl. Strength exercises were performed on both extremities using predetermined weight, calculated as 30% of 1-repitition (rep) maximum determined 1 week prior to the initiation of training Data collected at baseline and completion included limb circumferences and strength testing. This study concluded that low-load Blood Flow Restriction training increased muscle strength and limb circumference more than high- load Blood Flow Restriction training. Both the proximal and distal muscle groups were strengthened by Blood Flow Restriction exercise. A systemic or crossover effect could be confirmed by gains in the contralateral extremity.

In 2019, a randomized control trial had been conducted to determine the effects of Low-load blood flow restriction training that induces similar morphological and mechanical Achilles' tendon adaptations as compared with high-load resistance training. This study included 55 male volunteers those were randomly allocated into the following three groups: low load- Blood Flow Restriction, high load and a non-exercising control group. The low load- Blood Flow Restriction and high load groups completed a resistance training program for 14 week, and tendon morphology, mechanical as well as material properties, and muscle cross- sectional area and isometric strength were assessed before and after the intervention. This study concluded that the adaptive change in Achilles' tendon properties following low-load resistance training with partial vascular occlusion appears comparable to that evoked by high-load resistance training.

In 2018, a randomized control trial had been conducted to determine the effects of lower body blood flow restriction training may induce remote muscle strength adaptations in an active unrestricted arm. 24 participants were recruited in this study which were divided in two groups. an experimental Blood Flow Restriction group (EXP; n = 12) or a non- Blood Flow Restriction control group (CON; n = 12) completed 7-weeks of resistance training comprising three sets of unilateral bicep curls [50% 1-repetition maximum (1-RM)], then four sets of bilateral knee extension and flexion exercises (30% 1-RM). Experimental group performed leg exercises with an applied Blood Flow Restriction (60% limb occlusion pressure). 1-RM strength was measured using bilateral leg exercises and unilateral bicep curls in both trained and untrained arms. Muscle CSA was measured via peripheral quantitative computed tomography in the dominant leg and both arms. This study concluded that Blood Flow Restriction training increased trained arm strength more than the contralateral untrained arm, and the trained arm of control.

In 2018, a randomized control trial had been conducted to determine the effects of benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. This study recruited forty-eight women with knee OA were randomized into one of the three groups: low-intensity resistance training (30% one repetition maximum 1-RM) associated (BFRT) or not (LI-RT) with partial blood flow restriction, and high-intensity resistance training (HI- RT: 80% 1-RM). Patients underwent a 12-week supervised training program and were assessed for lower-limb 1-RM, quadriceps cross-sectional area (CSA), functionality (timed stands test - TST and timed-up-and-go test - TUG), and disease-specific inventory (Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC) before (PRE) and after the protocol (POST). This study concluded that BFRT and HI-RT were similarly effective in increasing muscle strength, quadriceps muscle mass, and functionality in knee OA patients. Importantly, BFRT was also able to improve pain while inducing less joint stress, emerging as a feasible and effective therapeutic adjuvant in OA management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both male & female participants
  • Age group between 30 to 60 years.
  • Subjects clinically diagnosed with prediabetes (41-49 mmol/mol) after fasting blood sugar (110-125 mg/dl) and Hb1Ac (5.7%-6.4%) or assessed using the diabetes risk assessment tool as having high risk of developing diabetes in the next five years.
  • Mean BMI for participants will be more than
  • Subjects able to understand simple instructions, independently or with assistance from their support person.

排除标准

  • History of any cardiovascular problems that limited safe participation in aerobic or resistance exercise.
  • Subjects who are unable to walk 30 min independently with or without a walking aid
  • History of any psychological disorder.

结局指标

主要结局

Hemoglobin A1c (HbA1c) test

时间窗: 16th week

,A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. An HbA1c test may be used to check for diabetes or prediabetes in adults. The Centers for Disease Control (CDC) recommends that adults over the age of 45 get tested to screen for diabetes and prediabetes. HbA1c results are given in percentages. Typical results for this test are Normal value of HbA1c below 5.7%, for prediabetes, HbA1c between 5.7% and 6.4%, for diabetes, HbA1c of 6.5% or higher.

Fasting Blood Sugar Level

时间窗: 16th week

This measures your blood sugar after an overnight fast (not eating). A fasting blood sugar level of 99 mg/dL or lower is normal, 100 to 125 mg/dL indicates you have prediabetes, and 126 mg/dL or higher indicates you have diabetes.

Australian type 2 diabetes risk assessment tool (AUSDRISK)

时间窗: 16th week

The Australian type 2 diabetes risk assessment tool (AUSDRISK) is a short list of questions. It helps both health professionals and individuals to assess the risk of a person developing type 2 diabetes over the next 5 years. It consists of 10 questions with each question containing 2 options. Individuals who score 5 or less than 5 are at low risk. Individuals who score 6 to 11 are at intermediate risk of developing diabetes. While, Individuals who score 12 or more are at high risk of developing diabetes

次要结局

  • World Health Organization Quality of Life(16th week)
  • 36-Item Short Form Survey(16th week)
  • International Physical Activity Questionnaires(16th week)
  • Rockport Walking Fitness Test(16th week)
  • Borg rating of perceived exertion(16th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验