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

17. května 2026 aktualizováno: Shazlin Shaharudin, Universiti Sains Malaysia

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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

36

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Singapur
      • Singapore, Singapur, 637616
        • National Institute of Education
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Shazlin Shaharudin, PhD
        • Dílčí vyšetřovatel:
          • Angela Frances Hui Wen Yap, PhD, MD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion criteria:

  1. males and females aged 60 until 85
  2. living in the community,
  3. confirmed diagnosis of MCI
  4. able to walk without assistance for at least two minutes,
  5. able to participate in exercise intervention screened by a physician based on ACSM guidelines

Exclusion criteria:

  1. uncertain diagnosis of MCI,
  2. did not screen for ability to participate in exercise intervention,
  3. presence of other neurological, psychiatric, or cognitive impairment disorders,
  4. seriously ill, presence of Hepatitis B or C, cancer, and patients on immunosuppressant drugs,
  5. type 2 diabetes mellitus,
  6. uncontrolled hypertension or hypotension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at rest),
  7. unstable cardiac, renal, lung, liver, or other severe chronic disease,
  8. history of myocardial infarction and/or stroke within previous year,
  9. vision/hearing disorder,
  10. musculoskeletal disorders that affect physical function such as osteoporosis, severe knee osteoarthritis, and degenerative spinal condition,
  11. presence of any major psychiatric disorder (a clinical diagnosis of major depressive disorder, bipolar or schizophrenia)
  12. history of vitamin B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed)
  13. serious or non-healing wound, ulcer, or bone fracture

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: 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 will continue usual care at Singapore General Hospital. The control group will have usual care only during the duration of this study.
Experimentální: 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.
Jiný: 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 will continue usual care at Singapore General Hospital. The control group will have usual care only during the duration of this study.
Žádný zásah: Control
The control group will continue their usual care from Singapore General Hospital during the period of this study

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cerebral blood flow
Časové okno: 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
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cognitive function
Časové okno: 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
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
Physical function
Časové okno: 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
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
Physical characteristic
Časové okno: 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
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
Level of depression
Časové okno: 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)
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended
Level of disability
Časové okno: 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)
Before 12-week intervention, immediately after 12-week intervention, and 4 weeks after intervention has ended

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sociodemographic
Časové okno: 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
Before 12-week intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Universiti Sains Malaysia

Spolupracovníci

Singapore General Hospital
National Institute of Education, Singapore

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2028

Termíny zápisu do studia

První předloženo

9. února 2026

První předloženo, které splnilo kritéria kontroly kvality

17. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB-2025-838

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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