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NCT Number: NCT07600034

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

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).

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Education

Singapore, 637616

Location contact

Angela Frances Hui Wen Yap, PhD, MD

SUB_INVESTIGATOR

Shazlin Shaharudin, PhD

SUB_INVESTIGATOR

Wei-Peng Assoc Prof Teo, PhD

CONTACT

[email protected]

(+65) 6790-3704

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Cerebral blood flow

    Time frame: 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

Secondary outcomes

  1. Cognitive function

    Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended

    Montreal Cognitive Assessment test: scores for mild cognitive impairment is from 19 to 25. Higher scores indicate worse cognitive function

  2. Physical function

    Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended

    Timed Up and Go test: to measure balance. Unit: time in seconds. Lower values indicate better mobility and balance

  3. Physical characteristic

    Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended

    Body fat percentage. Unit: percentage (%). Higher values indicate greater proportion of fat mass in the body composition

  4. Level of depression

    Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended

    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)

  5. Level of disability

    Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended

    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)

Other outcomes

  1. Sociodemographic

    Time frame: Before 12-week intervention

    • Self-report on sociodemographic characteristics, ethnicity, socioeconomic status, educational level, smoking status, alcohol intake, comorbidities, chronic medications, social activities, history of falls

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Collaborators

  • National Institute of Education, Singapore
  • Singapore General Hospital

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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