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

17. Mai 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

36

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Sonstiges: 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.
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.
Sonstiges: 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.
Kein Eingriff: Control
The control group will continue their usual care from Singapore General Hospital during the period of this study

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cerebral blood flow
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cognitive function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sociodemographic
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universiti Sains Malaysia

Mitarbeiter

Singapore General Hospital
National Institute of Education, Singapore

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

9. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB-2025-838

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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