Effectiveness of structured exercise based rehabilitation program on quality of life and hand function in type 2 diabetes mellitus with postmenopausal osteoporosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Ultrasound on the forearm to measure bone mineral density
研究概览
简要总结
In India there is high prevalence oftype 2 Diabetes mellitus. Between 20-79 years of population 66.8 million peopleare living with type 2 Diabetes. Diabetes national prevalence in India is8.63%. A study conducted to evaluate the handfunctioning in patients with diabetes and its impact onquality of life (QoL) in the physical and mental dimensions suggested thatimpaired hand function affects lower acceptance of the disease, the occurrenceof depression and reduced patient’s QoL. Studies have also shown that there isa high prevalence of upper limb and hand dysfunction in patients with type 2Diabetes mellitus in India. South Indian postmenopausal osteoporosis womenperform lesser physical activity compared to European women. It is well knownfrom the literature that there is high prevalence of osteoporosis inpostmenopausal women and also in women with type 2 diabetes mellitus in India.There is bone architectural changes and also bone loading changes areassociated with type 2 diabetes. South Indian women with type 2 Diabetesmellitus had lesser bone mineral density compared to normal women. The currentstudy focuses on estimation of prevalence of upper limb dysfunction and handfunction in postmenopausal women with osteoporosis with type 2 Diabetesmellitus. Effect of upper limb and hand dysfunction on hand function and QoLwill be measured. Effect of structured exercise based rehabilitation program onthe hand function and QoL will be evaluated. If the participants improve withthe intervention, structured exercises can be incorporated as part of treatment while treating type 2 diabetesmellitus with postmenopausal osteoporosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •type 2 diabetes mellitus with postmenopausal osteoporosis.
排除标准
- •Neurological conditions, cardiological conditions.
结局指标
主要结局
Ultrasound on the forearm to measure bone mineral density
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Prevalence of upper limb, deformities and conditions in people diagnosed with diabetes living in costal Karnataka, India
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Level of Physical Activity (PA) in person with diabetes using GPAQ
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Shoulder range of motion
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Grip strength
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Pinch strength
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Sensory evaluation
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Peg board test
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Michigan Hand outcome Questionnaire (MHQ)Upper extremity function evaluation by DASH
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
Quality of life using SF-36 questionnaire
时间窗: to find the prevalence one time assessment of the primary outcome measure at the point of contact, | For intervention the outcome will be assessed pre intervention and post intervention
次要结局
- Michigan Hand outcome Questionnaire (MHQ)Upper extremity function(evaluation by DASH)