Effectiveness of a new exercise program on hand muscle strength, dexterity and function among persons with type 2 diabetes mellitus in central part of Kerala
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Hand muscle grip strength
研究概览
简要总结
Type 2 diabetes mellitus is reported to be one of the highly prevalent metabolic disease across the globe especially in developing countries like India. Scientific literature reported that the hand function, strength and dexterity are affected in type 2 diabetes mellitus which can impair the activities of daily living. There is scarcity of literature on exercise interventions to improve hand function in persons with type 2 diabetes. Therefore this study is designed to develop a structured exercise program incorporating all aspects of hand function like muscle strength, dexterity, flexibility and functional training.
The phase 1 of the study is designed to develop the exercise program for hand function and validate it through face, content and construct validation process. Phase 2 will be implementation of the exercise program on target population to investigate the effect of the new exercise program on hand functions among persons with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Persons who are clinically diagnosed with type 2 diabetes mellitus and age between 50 and 70 years Both genders Persons who are under oral hypoglycemic drugs and or insulin Screening tests for musculoskeletal manifestations Prayer sign or Preachers sign positive and or Table top sign positive Hand muscle grip strength lower than 27 kg in males and 21 kg in females on dominant hand using hand held dynamometer.
- •based on established normal values in Indian population Hand palmar pinch strength lower than 4 kg in males and 2 kg in females on dominant hand using pinch gauge.
- •based on established normal values in Indian population Hand gross dexterity lower than 73 blocks in one minute in males and 75 blocks per minute in females on dominant hand using box and block test Hand fine dexterity more than 20 seconds in males and 18 seconds in females on dominant hand using nine hole peg test.
排除标准
- •Musculoskeletal neurological metastatic involvement of cervical spine or upper extremity Peripheral nerve injury affecting upper limb in past 6 months History of wrist and hand trauma or surgery in past 3 months Rheumatic degenerative disease and other musculoskeletal and neurological diseases Impairments affecting upper extremity due to central peripheral or autonomic nervous system MMSE score less than 24 showing impairment in cognition Amputation joint fusion upper limb arthroplasty Recent upper limb fractures and or surgeries in past 6 months Reflex sympathetic dystrophy History of diabetic complications like severe nephropathy severe retinopathy and significant cardio vascular impairments.
结局指标
主要结局
Hand muscle grip strength
时间窗: At baseline - pre-test assessment | At 8 weeks - Post test assessment
Pinch strength
时间窗: At baseline - pre-test assessment | At 8 weeks - Post test assessment
Hand gross dexterity
时间窗: At baseline - pre-test assessment | At 8 weeks - Post test assessment
Fine hand dexterity
时间窗: At baseline - pre-test assessment | At 8 weeks - Post test assessment
次要结局
- Hand functional activity(Hand joint mobility)
研究者
Anila Paul
Medical Trust Institute of Medical Sciences, Medical Trust Hospital,