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

Overview

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

• Other Exercise 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 wil

Primary outcome measures

• Cerebral blood flow [Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended]

Secondary outcome measures (5)

• Cognitive function [Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended]
• Physical function [Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended]
• Physical characteristic [Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended]
• Level of depression [Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended]
• Level of disability [Time frame: Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Singapore · 1 center

• National Institute of Education — Singapore

Identifiers

NCT: NCT07600034 · IRB-2025-838

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗