Muscular and Cerebral Oxygenation Changes After Moderate-Intensity Exercise in Sedentary Older Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- normalized ∆SmO2 rate
研究概览
简要总结
The aim of the study is to determine the physiological evidence of how muscular and cerebral oxygenation changes link to fatigue, physical, and cognitive performance after moderate-intensity exercise in sedentary older adults with type 2 diabetes.
详细描述
This is an experimental design. One intervention group will do exercise for 2 months and be measured twice, at baseline, and after 2 months. The other 2 control groups will be assessed just once without exercise intervention. Our primary objective is to clarify physiological evidence of how muscular and cerebral oxygenation changes in sedentary older adults with diabetes after low-to-moderate intensity exercise. The secondary objective is to determine fatigue, physical, cognitive performance changes, blood glucose level among sedentary older adults with diabetes after low-to-moderate intensity exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the intervention group, the inclusion criteria are
- •sedentary older adults 60 years or older who are living in their homes in the community
- •diagnosed type 2 diabetes
- •ambulatory with or without mobility devices such as a cane and/or walker
- •Be able to follow simple exercise instructions without assistance.
- •For the comparison group, the inclusion criteria are
- •individuals aged 60 years or older who are living in their homes, in the community;
- •ambulatory with or without devices;
- •able to follow simple exercise instructions without assistance
- •able to walk six minutes as quickly as possible without any adverse symptoms including extreme pain on feet or joints, dizziness, vertigo, or nausea.
排除标准
- •For the intervention group, the exclusion criteria are
- •foot deformities, cuts, blisters, or amputation, Achilles tendonitis, joint replacements within the past three months, Parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders
- •current smoking or smoking within the last 12 months
- •current cardiopulmonary diseases, vascular disease, or stroke
- •dementia indicating the inability to follow exercise instructions independently
- •those who are currently or plan to receive physical therapy in the following three months
- •individuals without English proficiency will be excluded
- •If the individuals with blood glucose level are over 400 mg/dL or HbA1C > 8.0%, and
- •type 1 diabetes.
- •For the comparison group, the exclusion criteria are
- •individuals who have prediabetes, diabetes, or current cardiopulmonary diseases and stroke
- •current smoking or smoking within the last 12 months
- •individuals with foot deformities, cuts, blisters, or amputation, Achilles tendonitis, joint replacements within the past three months, Parkinson's disease, retinopathy such as severe glaucoma, current or uncontrolled vestibular disorders, and dementia.
结局指标
主要结局
normalized ∆SmO2 rate
时间窗: measure twice, at baseline and after 2 months
a parameter of muscular oxygenation to indicate the match or mismatch between oxygen supply and oxygen demand during the physical stimulus.
recovery time
时间窗: measure twice, at baseline and after 2 months
a parameter of muscular oxygenation, time taken in seconds after the exercise to back to the beginning oxygenation level.
Oxyhemoglobin differences
时间窗: measure twice, at baseline and after 2 months
a parameter of cerebral oxygenation, the difference of the oxyhemoglobin in mL per gram before and after the cognitive tests.
Resting SmO2
时间窗: measure twice, at baseline and after 2 months
a parameter of muscular oxygenation, the average oxygenation level in % while sitting still for 3 minutes before doing physical performance tests.
次要结局
- Fatigue(measure twice, at baseline and after 2 months)
- Mini-cog test(measure twice, at baseline and after 2 months)
- Trail Making Test(measure twice, at baseline and after 2 months)
- Timed Up and Go test score in seconds(measure twice, at baseline and after 2 months)
- Bilateral Heel Raise test(measure twice, at baseline and after 2 months)
- blood glucose level in mg/dL(measure twice, at baseline and after 2 months)
- Short Physical Performance Battery(measure twice, at baseline and after 2 months)
- 6 Minute Walking Test(measure twice, at baseline and after 2 months)
研究者
Fei Zhao
Ph.D. candidate student, MPT
State University of New York at Buffalo