Effects of cognitive motor dual task training with blindfold on cognition in type 2 diabetes mellitus - A Randomised control trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Cognitive function
研究概览
简要总结
Type 2 diabetes mellitus is one most major health burden for the elderly population, affecting approximately 25% of people over the age of 65 years. Beyond microvascular and macrovascular complications, cognitive decline has been described as a new diabetes complication in the elderly population. Increased level of attention has been paid by researchers and clinicians to this age-related condition— which is characterized by loss of dual task activity together with loss of cognitive function—in individuals with T2DM; this is due to the heavy impact that cognitive decline may have on physical and psychosocial health of diabetic patients, thus affecting their quality of life. The main aim of the Randomised controlled trial (RCT) to determine the effect of cognitive motor dual task training with and without blindfold exercise on cognition in people with T2DM. We hypothesized that here will be significant difference in the effects of cognitive motor dual task blindfold training, cognitive motor dual task training and conventional therapy on cognition in type 2 diabetes mellitus.
Methods: A randomized controlled and parallel three arm trial with patient blinded. A total of 93 patients with type 2 diabetes mellitus aged 40-65 either gender with HbA1c > 6.6 mmol/dL and more than 5 years of education. The eligible subjects will undergo for baseline assessment of BMI, Muscle strength, duration of disease. Then the subjects will be allocated to each group through random lottery method. After allocation the subjects in the experimental group A group will receive CMDBT, experimental group B group will receive CMDT and control group will receive conventional therapy of aerobic and resistance training 3 sessions / week for 12 consecutive weeks. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcome measures are Montreal cognitive assessment and Trail making test.
Discussion: This research study focuses mainly on the cognitive function. In order to ensure the quality of the experiment, this study gives the treatment plan in detail and establishes a unified framework. Later results analysis will be done, this study believes that this cognitive motor dual task training with blindfold will effectively help to improve cognitive function in type 2 diabetes mellitus subjects.
Key words: Type 2 Diabetes mellitus, Cognitive function, Cognitive motor dual task training, Cognitive decline and Blind fold training.
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 Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of T2DM > 5years confirmed by the physician;
- •Age between 40 to 70 year: either gender;
- •HbA1C level : above 6.5 mmol/dL
- •Education level more than 5 years
- •Sufficient cognitive level for understanding and agreement to participate in the study.
排除标准
- •Mini- Mental State Examination [MMSE] score less than 24;
- •Diagnosis of progressive neurological disease;
- •Limited mobility;
- •Diagnosis of cardiovascular disorder;
- •Diagnosis of microvascular and macrovascular complications and symptom of diabetic neuropathy;
- •Occurrence of skin lesion or local infection over the dorsiflexor and plantar flexor muscle;
- •Inability to undergo evaluations in a satisfactory manner;.
结局指标
主要结局
Cognitive function
时间窗: 12 week | & 18th week follow up
次要结局
- Association of HbA1c level(Muscle strength)