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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 637616
- National Institute of Education
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Contacto:
- Wei-Peng Assoc Prof Teo, PhD
- Número de teléfono: (+65) 6790-3704
- Correo electrónico: weipeng.teo@nie.edu.sg
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Sub-Investigador:
- Shazlin Shaharudin, PhD
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Sub-Investigador:
- Angela Frances Hui Wen Yap, PhD, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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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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. |
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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Sin intervención: Control
The control group will continue their usual care from Singapore General Hospital during the period of this study
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cerebral blood flow
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cognitive function
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Sociodemographic
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-2025-838
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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