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).
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Singapore、シンガポール、637616
- National Institute of Education
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コンタクト：
- Wei-Peng Assoc Prof Teo, PhD
- 電話番号：(+65) 6790-3704
- メール：weipeng.teo@nie.edu.sg
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副調査官：
- Shazlin Shaharudin, PhD
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副調査官：
- Angela Frances Hui Wen Yap, PhD, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
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実験的：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. |
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.
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介入なし：Control
The control group will continue their usual care from Singapore General Hospital during the period of this study
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Cerebral blood flow
時間枠：Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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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
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Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cognitive function
時間枠：Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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Montreal Cognitive Assessment test: scores for mild cognitive impairment is from 19 to 25.
Higher scores indicate worse cognitive function
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Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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Physical function
時間枠：Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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Timed Up and Go test: to measure balance.
Unit: time in seconds.
Lower values indicate better mobility and balance
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Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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Physical characteristic
時間枠：Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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Body fat percentage.
Unit: percentage (%).
Higher values indicate greater proportion of fat mass in the body composition
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Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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Level of depression
時間枠：Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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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)
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Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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Level of disability
時間枠：Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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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)
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Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Sociodemographic
時間枠：Before 12-week intervention
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• Self-report on sociodemographic characteristics, ethnicity, socioeconomic status, educational level, smoking status, alcohol intake, comorbidities, chronic medications, social activities, history of falls
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Before 12-week intervention
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB-2025-838
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data confidentiality Human subjects participation in this study will involve the collection, use and disclosure of data / health information in an individually identifiable form (or "Personal Data"). "Personal Data" means data about the participants, which makes them identifiable from (i) such data, and/or from (ii) other information which we have or likely have access to. This includes written, visual, video, audio data/recordings, medical conditions, medications, investigations and treatment history.
Personal Data and data collected for this study will be kept confidential and stored for a minimum of 10 years in a secure environment within NTU. Access will be restricted to the Principal Investigator, study team members, and School Administrators. The records, to the extent of the applicable laws and regulations, will not be made publicly available, in accordance with the NTU Privacy Statement.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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