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| Name | Class |
|---|---|
| Singapore General Hospital | OTHER |
| National Institute of Education, Singapore | OTHER |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance exercise | Experimental | 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. |
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| Aerobic exercise | Experimental | 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. |
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| Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Other | Participation will last approximately 18 weeks (2 weeks of familiarization and assessment, 12 weeks of exercise intervention, and 4 weeks of follow-up). Participants will be randomized into three groups, either cycling group, strength training group or control group. Those in the cycling group and strength training group will undergo exercise intervention for about 2 sessions per week for 12 weeks (total 24 times) and will be followed for 4 weeks. The study will involve 28 visits. All groups will continue usual care at Singapore General Hospital. The control group will have usual care only during the duration of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral blood flow | 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 | Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | Montreal Cognitive Assessment test: scores for mild cognitive impairment is from 19 to 25. Higher scores indicate worse cognitive function | Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended |
| Physical function |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic | • Self-report on sociodemographic characteristics, ethnicity, socioeconomic status, educational level, smoking status, alcohol intake, comorbidities, chronic medications, social activities, history of falls | Before 12-week intervention |
Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Education | Singapore | 637616 | Singapore |
Data confidentiality Human subjects participation in this study will involve the collection, use and disclosure of data / health information in an individually identifiable form (or "Personal Data"). "Personal Data" means data about the participants, which makes them identifiable from (i) such data, and/or from (ii) other information which we have or likely have access to. This includes written, visual, video, audio data/recordings, medical conditions, medications, investigations and treatment history.
Personal Data and data collected for this study will be kept confidential and stored for a minimum of 10 years in a secure environment within NTU. Access will be restricted to the Principal Investigator, study team members, and School Administrators. The records, to the extent of the applicable laws and regulations, will not be made publicly available, in accordance with the NTU Privacy Statement.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The control group will continue their usual care from Singapore General Hospital during the period of this study |
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Timed Up and Go test: to measure balance. Unit: time in seconds. Lower values indicate better mobility and balance |
| Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended |
| Physical characteristic | Body fat percentage. Unit: percentage (%). Higher values indicate greater proportion of fat mass in the body composition | Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended |
| Level of depression | Patient Health Questionnaire-9 is a 9-item tool used to screen for and measure the severity of depression. Each item is scored on a scale from 0 (Not at all) to 3 (Nearly every day). Minimum Score: 0 (Indicates no depressive symptoms). Maximum Score: 27 (Indicates severe depression) | Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended |
| Level of disability | The World Health Organization Disability Assessment Schedule measures general health and disability. Each 12 individual items are rated from 0 (None) to 4 (Extreme or cannot do). Minimum Score: 0 (No functional disability) Maximum Score: 48 (Full/maximum functional disability) | Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended |