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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorUniversiti Sains Malaysia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Exercise training

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Resistance exerciseExperimental treatment 1 intervention
Group B: Aerobic exerciseExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

Cognitive function

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

Time frame
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
2

Physical function

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

Time frame
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
3

Physical characteristic

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

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

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)

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

Other outcomes

1

Sociodemographic

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

Time frame
Before 12-week intervention

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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