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

Sponsor
Universiti Sains Malaysia
Study ID
NCT07600034
Status
Not Yet Recruiting

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Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

First listed
May 20, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Resistance exercise
    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.
  • Experimental: Aerobic exercise
    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.
  • No Intervention: Control
    The control group will continue their usual care from Singapore General Hospital during the period of this study

Primary Outcome Measure

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

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