Optimising Exercise to Improve Physical and Cognitive Frailty in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cerebral blood flow
研究概览
简要总结
This investigational research aims to understand the mechanism of delaying the progression of dementia through different types of exercise. Exercise plays a protective role by attenuating the progression of cognitive impairments in mild cognitive impairment (MCI), an early and reversible stage of dementia. However, how different types of exercise induce changes in physical frailty and cognitive function is understudied. The participants will be randomized to receive an exercise intervention program (cycling or strength training) for 12 weeks or a control group.
The participants will be asked to perform certain cognitive and physical assessments at the start of the study, at the end of 12 weeks of exercise intervention, and 4 weeks after the end of the intervention. Below is the list of the assessments:
- Patient Health Questionnaire-9 (PHQ-9)
- World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0-12)
- Self-report on sociodemographic characteristics, ethnicity, socioeconomic status, educational level, smoking status, alcohol intake, comorbidities, chronic medications, social activities, history of falls
- body height, weight and fat percentage, heart rate, blood pressure, Dual-Energy X-Ray Absorptiometry (DEXA) scan: measurements to evaluate overall physical characteristics
- handgrip strength: to evaluate musculoskeletal function
- Stroop test: to evaluate information processing speed and executive cognitive control
- n-back task: to evaluate working memory and executive function
- Timed Up and Go (TUG) test: to measure balance
- single-task gait: to measure walking ability
- double-task gait: to measure walking stability and attention
During Stroop test, n-back task, Timed Up and Go (TUG) test, single-task gait and double-task gait, the participants will be equipped with a mobile functional near-infrared spectroscopy (fNIRS) device over their forehead. This device is used to detect changes in blood flow in the front area of the brain.
Their participation will last approximately 18 weeks (2 weeks of familiarization and assessment, 12 weeks of exercise intervention, and 4 weeks of follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females aged 60 until 85
- •living in the community,
- •confirmed diagnosis of MCI
- •able to walk without assistance for at least two minutes,
- •able to participate in exercise intervention screened by a physician based on ACSM guidelines
排除标准
- •uncertain diagnosis of MCI,
- •did not screen for ability to participate in exercise intervention,
- •presence of other neurological, psychiatric, or cognitive impairment disorders,
- •seriously ill, presence of Hepatitis B or C, cancer, and patients on immunosuppressant drugs,
- •type 2 diabetes mellitus,
- •uncontrolled hypertension or hypotension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at rest),
- •unstable cardiac, renal, lung, liver, or other severe chronic disease,
- •history of myocardial infarction and/or stroke within previous year,
- •vision/hearing disorder,
- •musculoskeletal disorders that affect physical function such as osteoporosis, severe knee osteoarthritis, and degenerative spinal condition,
- •presence of any major psychiatric disorder (a clinical diagnosis of major depressive disorder, bipolar or schizophrenia)
- •history of vitamin B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed)
- •serious or non-healing wound, ulcer, or bone fracture
研究组 & 干预措施
Resistance exercise
There are 4 lower limb exercises namely seated knee extension, plantar flexion through calf raises, hip abduction by moving the straight leg sideways, and hip extension by moving the straight leg backwards. The three standing exercises will be conducted while the participants hold on to a chair. Exercise intensity will be increased gradually by increasing the number of repetitions and by affixing weights around the ankles. All participants will start with 3 sets of 8 repetitions for each leg without weights. When a participant performs an exercise with ease, the number of repetitions will be increased to 10 in the next session, and 12 in the session thereafter. When a participant can correctly perform 12 repetitions without weights, at RPE <12, a weight of 0.5 kg will be attached to their ankles. Each exercise session will end with 5-min stretching. HR will be monitored and recorded continuously during exercise session.
干预措施: Exercise training (Other)
Aerobic exercise
The aerobic group will perform moderate intensity walking sessions indoors. The targeted exercise intensity corresponds to 50-60% of the individual heart rate reserve (HRR, HRmax-HRresting) during the first two weeks and 70-75% of the HRR for the remainder of the program (Tsai et al., 2019). HRmax for male will be determined from equation based on Gellish et al., (2007) = 207-0.7(age), HRmax for female will be determined from equation based on Gulati et al., (2010) = 206-0.88(age). Resting heart rate will be determined based on the first visit (baseline assessment) and verified prior to start of each exercise session.
Each aerobic exercise session involved a 5-minute warm-up period, followed by 30 minutes of continuous brisk walking at an intensity that would maintain the heart rate within the assigned training range, followed by 5 minutes of stretching. If rest is requested, an appropriate rest period will be included in the 30-minute walk session.
干预措施: Exercise training (Other)
Control
The control group will continue their usual care from Singapore General Hospital during the period of this study
结局指标
主要结局
Cerebral blood flow
时间窗: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
Participants will be equipped with a mobile functional near-infrared spectroscopy (fNIRS) device over their forehead. This device is used to detect changes in blood flow in the front area of the brain. Unit: the standard physiological units for brain perfusion: milliliters of blood per 100 grams of brain tissue per minute. Higher values indicate greater perfusion
次要结局
- Cognitive function(Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended)
- Physical function(Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended)
- Physical characteristic(Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended)
- Level of depression(Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended)
- Level of disability(Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended)
研究者
Shazlin Shaharudin
Postdoctoral fellow
Universiti Sains Malaysia