Effects of Pulsed Electromagnetic Field Therapy in Individuals with Diabetes Mellitus Type 2 : A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Fasting blood glucose
研究概览
简要总结
This study is a randomised controlled trial to study the effect of pulsed electromagnetic field therapy on blood glucose levels in individuals with diabetes mellitus type 2.
Pulsed Electromagnetic Field Therapy will be administered for 12 weeks along with exercise therapy in one group and compared with the other group receiving only exercise therapy alone. The Fasting Blood Glucose levels, HbA1c will be assessed at pre- treatment, After 24 sessions, after 48 sessions and at post - treatment. .Nitric oxide concentration estimation would be done at pre - treatment and post - treatment. If required the outcome measures would be assessed earlier if patients feel uneasy due to a drop in blood sugar levels. Before beginning with a trial a pilot study would be undertaken to choose the best parameters of P.E.M.F. therapy. Also, based on pilot study any changes or modifications required will be made in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals diagnosed with Diabetes Mellitus Type 2 for more than 6 months (Fasting Plasma Glucose > 126 mg/dL <280 mg/dL; HbA1c> 6.5% <15.6%) Individuals on Normal Blood Glucose concentration lowering medications.
排除标准
- •Individuals having a difficulty in attaining sitting position for 30 minutes.
- •Suffering from acute fractures in the spinal region.
- •Individuals with musculoskeletal disorders like strains, sprains, fractures causing an impairment to perform physical activity.
- •Suffering from cardio.
- •vascular disorders.
- •Suffering from neurological disorders.
- •Individuals with diabetes mellitus type 2 suffering from foot ulcers.
- •Individuals undergoing any other form of exercise training.
- •Individuals who are hypoglycemic.
- •Individuals who are handicapped.
- •Pregnant females.
- •Individuals who are suffering from cancer.
- •Individuals who are having sensory impairment.
- •Individuals suffering from kidney dysfunction or disorders.
- •Individuals with pacemaker.
- •Individuals with implants of gel or silicon and / or transplant organs.
结局指标
主要结局
1. Fasting blood glucose
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks
2. HbA1c
时间窗: At baseline, 4 weeks, 8 weeks, 12 weeks
次要结局
- 1. Nitric oxide concentration(1. Baseline)