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

17 mai 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

36

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Singapour
      • Singapore, Singapour, 637616
        • National Institute of Education
        • Contact:
        • Sous-enquêteur:
          • Shazlin Shaharudin, PhD
        • Sous-enquêteur:
          • Angela Frances Hui Wen Yap, PhD, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Expérimental: 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.
Autre: 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.
Aucune intervention: Control
The control group will continue their usual care from Singapore General Hospital during the period of this study

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cerebral blood flow
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cognitive function
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Sociodemographic
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universiti Sains Malaysia

Collaborateurs

Singapore General Hospital
National Institute of Education, Singapore

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

9 février 2026

Première soumission répondant aux critères de contrôle qualité

17 mai 2026

Première publication (Réel)

20 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB-2025-838

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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