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Optimising Exercise to Improve Physical and Cognitive Frailty in Mild Cognitive Impairment

Optimising Exercise to Improve Physical and Cognitive Frailty in Mild Cognitive Impairment

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07600034
Enrollment
36
Registered
2026-05-20
Start date
2026-07-01
Completion date
2028-12-31
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI)

Keywords

Aerobic exercise, Strength training, fNIRs, Ageing

Brief summary

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).

Interventions

OTHERExercise training

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.

Sponsors

Universiti Sains Malaysia
Lead SponsorOTHER
Singapore General Hospital
CollaboratorOTHER
National Institute of Education, Singapore
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. males and females aged 60 until 85 2. living in the community, 3. confirmed diagnosis of MCI 4. able to walk without assistance for at least two minutes, 5. able to participate in exercise intervention screened by a physician based on ACSM guidelines

Exclusion criteria

1. uncertain diagnosis of MCI, 2. did not screen for ability to participate in exercise intervention, 3. presence of other neurological, psychiatric, or cognitive impairment disorders, 4. seriously ill, presence of Hepatitis B or C, cancer, and patients on immunosuppressant drugs, 5. type 2 diabetes mellitus, 6. uncontrolled hypertension or hypotension (systolic blood pressure \>160 mm Hg and/or diastolic blood pressure \>100 mm Hg at rest), 7. unstable cardiac, renal, lung, liver, or other severe chronic disease, 8. history of myocardial infarction and/or stroke within previous year, 9. vision/hearing disorder, 10. musculoskeletal disorders that affect physical function such as osteoporosis, severe knee osteoarthritis, and degenerative spinal condition, 11. presence of any major psychiatric disorder (a clinical diagnosis of major depressive disorder, bipolar or schizophrenia) 12. history of vitamin B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed) 13. serious or non-healing wound, ulcer, or bone fracture

Design outcomes

Primary

MeasureTime frameDescription
Cerebral blood flowBefore 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has endedParticipants 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

MeasureTime frameDescription
Cognitive functionBefore 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has endedMontreal Cognitive Assessment test: scores for mild cognitive impairment is from 19 to 25. Higher scores indicate worse cognitive function
Physical functionBefore 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has endedTimed Up and Go test: to measure balance. Unit: time in seconds. Lower values indicate better mobility and balance
Physical characteristicBefore 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has endedBody fat percentage. Unit: percentage (%). Higher values indicate greater proportion of fat mass in the body composition
Level of depressionBefore 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has endedPatient 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)
Level of disabilityBefore 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has endedThe 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)

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026