About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
Exercise training
Other interventionParticipation 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Cognitive function
Montreal Cognitive Assessment test: scores for mild cognitive impairment is from 19 to 25. Higher scores indicate worse cognitive function
Physical function
Timed Up and Go test: to measure balance. Unit: time in seconds. Lower values indicate better mobility and balance
Physical characteristic
Body fat percentage. Unit: percentage (%). Higher values indicate greater proportion of fat mass in the body composition
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)
Other outcomes
Sociodemographic
• Self-report on sociodemographic characteristics, ethnicity, socioeconomic status, educational level, smoking status, alcohol intake, comorbidities, chronic medications, social activities, history of falls
Sponsors and contacts
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Universiti Sains Malaysia
Lead sponsor
Singapore General Hospital
Collaborator
National Institute of Education, Singapore
Collaborator
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