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rTMS Combined With Aerobic Exercise for Older Adults With Mild Cognitive Impairment and Comorbid Depression

11 de junio de 2026 actualizado por: Cheng-Hsin General Hospital

Effects of Repetitive Transcranial Magnetic Stimulation Combined With Aerobic Exercise on Cognitive Function, Psychological Health, and Walking Performance in Older Adults With Mild Cognitive Impairment and Comorbid Depression: A Randomized Controlled Trial

This study aims to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) and aerobic exercise on cognitive function and mental health in older adults with mild cognitive impairment (MCI) and comorbid depression. Forty-five participants will be randomly assigned to one of three groups: (1) rTMS alone, (2) rTMS combined with stationary cycling exercise, or (3) sham rTMS combined with stationary cycling exercise. Participants will receive 20 intervention sessions over a 5-week period (4 sessions per week). Outcomes, including cognitive function, depressive symptoms, sleep quality, life satisfaction, self-efficacy, and gait performance, will be assessed at baseline, immediately after completion of the 5-week intervention, and at a 1-month follow-up. The findings may contribute to the development of evidence-based, non-pharmacological interventions for improving cognitive and mental health outcomes in older adults with MCI and comorbid depression.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Mild cognitive impairment (MCI) is a transitional stage between normal aging and dementia and is frequently accompanied by depressive symptoms. Older adults with MCI and comorbid depression are at increased risk of cognitive decline, functional impairment, reduced quality of life, and progression to dementia. Therefore, effective non-pharmacological interventions targeting both cognitive and mental health outcomes are needed.

This study aims to investigate the effects of rTMS alone and rTMS combined with aerobic exercise on cognitive and mental health outcomes in older adults with MCI and comorbid depression. A randomized controlled trial design will be employed. Forty-five eligible participants who provide written informed consent will be randomly assigned to one of three groups: (1) rTMS alone, (2) rTMS combined with stationary cycling exercise, and (3) sham rTMS combined with stationary cycling exercise.

All participants will receive 20 intervention sessions over a 5-week intervention period (4 sessions per week). Intervention sessions will be conducted on Monday, Tuesday, Thursday, and Friday. Participants in the rTMS-alone group will receive a 5-minute rTMS session only. Participants in the rTMS combined with stationary cycling exercise group and the sham rTMS combined with stationary cycling exercise group will receive either active or sham rTMS for 5 minutes, followed by 30 minutes of stationary cycling exercise.

The stimulation target will be the left dorsolateral prefrontal cortex (DLPFC). For sham stimulation, a figure-of-eight coil will be positioned with one wing angled at 90 degrees relative to the scalp and maintained approximately 3 cm from the scalp surface to mimic the sensory experience of active stimulation while minimizing effective cortical stimulation.

Outcome assessments will be conducted at baseline, immediately after completion of the 5-week intervention period, and at a 1-month follow-up. Outcome measures will include cognitive function, depressive symptoms, sleep quality, life satisfaction, self-efficacy, and gait performance. Each assessment session is expected to require approximately 45 minutes.

The findings may provide evidence supporting the application of combined neuromodulation and aerobic exercise interventions for improving cognitive and mental health outcomes in older adults with MCI and comorbid depression.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

45

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ya-Chu Chan, MS Candidate
  • Número de teléfono: +886-983-559-807
  • Correo electrónico: aya45285@gmail.com

Ubicaciones de estudio

  • Taiwán
    • Taipei City
      • Taipei, Taipei City, Taiwán, 112
        • Reclutamiento
        • Cheng Hsin General Hospital
        • Contacto:
          • Ya-Chu Chan, MS Candidate
          • Número de teléfono: +886-983-559-807
          • Correo electrónico: aya45285@gmail.com
        • Contacto:
          • Kai-Chen Chan, MD
          • Número de teléfono: +886-983-559-807
          • Correo electrónico: aya45285@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Aged 65 to 90 years.
  2. Diagnosed with mild cognitive impairment (MCI) according to established clinical criteria.
  3. Presence of depressive symptoms as determined by clinical assessment and Beck Depression Inventory-II (BDI-II).
  4. Able to communicate and follow study instructions.
  5. Able to ambulate independently with or without an assistive device.
  6. Able to provide written informed consent.

Exclusion Criteria:

  1. Diagnosis of dementia.
  2. History of epilepsy or seizure disorder.
  3. Presence of metallic implants, pacemakers, cochlear implants, or other contraindications to transcranial magnetic stimulation.
  4. Major neurological disorders, including stroke, Parkinson's disease, traumatic brain injury, or other neurodegenerative diseases.
  5. Severe psychiatric disorders other than depression.
  6. Severe cardiovascular, musculoskeletal, or medical conditions that preclude participation in aerobic exercise.
  7. Severe visual or hearing impairments that interfere with cognitive assessment.
  8. Current participation in another intervention study.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: rTMS Alone
Participants receive active repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC). Stimulation sessions are conducted 4 times per week for 5 weeks (20 sessions total).
Dispositivo: Repetitive Transcranial Magnetic Stimulation
Active repetitive transcranial magnetic stimulation (rTMS) is delivered over the left dorsolateral prefrontal cortex (DLPFC) using a figure-of-eight coil. Participants receive stimulation sessions 4 times per week for 5 weeks (20 sessions total).
Otros nombres:
  • rTMS
Experimental: rTMS Combined With Aerobic Exercise
Participants receive active repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC), immediately followed by 30 minutes of moderate-intensity stationary cycling exercise. Sessions are conducted 4 times per week for 5 weeks (20 sessions total).
Dispositivo: Repetitive Transcranial Magnetic Stimulation
Active repetitive transcranial magnetic stimulation (rTMS) is delivered over the left dorsolateral prefrontal cortex (DLPFC) using a figure-of-eight coil. Participants receive stimulation sessions 4 times per week for 5 weeks (20 sessions total).
Otros nombres:
  • rTMS
Conductual: Aerobic Exercise
Participants perform 30 minutes of moderate-intensity stationary cycling exercise immediately following rTMS or sham rTMS sessions. Exercise sessions are conducted 4 times per week for 5 weeks (20 sessions total).
Experimental: Sham rTMS Combined With Aerobic Exercise
Participants receive sham repetitive transcranial magnetic stimulation (rTMS) targeting the left dorsolateral prefrontal cortex (DLPFC), immediately followed by 30 minutes of moderate-intensity stationary cycling exercise. Sham stimulation is delivered using a figure-of-eight coil positioned at a 90-degree angle relative to the scalp and approximately 3 cm from the scalp surface to mimic the sensory and auditory experience of active stimulation without inducing effective cortical activation. Sessions are conducted 4 times per week for 5 weeks (20 sessions total).
Conductual: Aerobic Exercise
Participants perform 30 minutes of moderate-intensity stationary cycling exercise immediately following rTMS or sham rTMS sessions. Exercise sessions are conducted 4 times per week for 5 weeks (20 sessions total).
Dispositivo: Sham Repetitive Transcranial Magnetic Stimulation
Sham stimulation is delivered using a figure-of-eight coil positioned at a 90-degree angle relative to the scalp and approximately 3 cm away from the scalp surface to mimic the sensory and auditory experience of active stimulation without producing effective cortical activation. Participants receive sham stimulation sessions 4 times per week for 5 weeks (20 sessions total).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in global cognitive function measured using the Montreal Cognitive Assessment (MoCA). Higher scores indicate better cognitive performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Geriatric Depression Scale-15 (GDS-15)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in depressive symptoms measured using the Geriatric Depression Scale-15 (GDS-15). Higher scores indicate greater depressive symptom severity.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Lower scores indicate better sleep quality.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Trail Making Test Part A (TMT-A)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in attention and processing speed measured using the Trail Making Test Part A. Shorter completion times indicate better performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Trail Making Test Part B (TMT-B)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Shorter completion times indicate better executive functioning and cognitive flexibility.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
California Verbal Learning Test-Short Form (CVLT-SF)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in verbal learning and memory measured using the California Verbal Learning Test-Short Form (CVLT-SF). Higher scores indicate better verbal learning and memory performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Stroop Color-Word Test
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in executive function, selective attention, and inhibitory control measured using the Stroop Color-Word Test (SCWT). Performance is assessed as the number of correct responses completed within 1 minute. Higher scores indicate better executive function, selective attention, and inhibitory control.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Digit Span Forward Test
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in attention span and immediate verbal memory measured using the Digit Span Forward Test. Higher scores indicate better attention and short-term memory performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Digit Span Backward Test
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in working memory and executive function measured using the Digit Span Backward Test. Higher scores indicate better working memory performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Beck Depression Inventory-II (BDI-II)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Higher scores indicate greater depressive symptom severity.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in health-related quality of life measured using the EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index). Higher scores indicate better health-related quality of life.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in quality of life measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). Higher scores indicate better quality of life.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Chinese Aging Well Profile (CAWP)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in subjective well-being measured using the Chinese Aging Well Profile (CAWP). Higher scores indicate better subjective well-being.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Timed Up and Go Test (TUG)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in functional mobility measured using the Timed Up and Go Test (TUG). Participants are instructed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Shorter completion times indicate better functional mobility and balance performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
EuroQol Visual Analogue Scale Score (EQ-VAS)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in self-rated health status measured using the EuroQol Visual Analogue Scale (EQ-VAS). Higher scores indicate better perceived health status.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Dual-task gait speed (m/s)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in dual-task gait speed measured in meters per second (m/s). Higher values indicate better gait performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Dual-task cadence (steps/min)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in dual-task cadence measured in steps per minute. Higher values indicate better gait performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Dual-task stride length (m)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Changes in dual-task stride length measured in meters. Higher values indicate better gait performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Dual-task cost (%)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Percentage change in gait performance during dual-task walking relative to single-task walking.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Single-task gait speed (m/s)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Walking speed during single-task walking, measured in meters per second.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Single-task cadence (steps/min)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Higher values indicate better gait performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Single-task stride length (m)
Periodo de tiempo: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
Higher values indicate better gait performance.
Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Cheng-Hsin General Hospital

Investigadores

  • Investigador principal: Kai-Chen Wang, MD, Cheng-Hsin General Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

3 de marzo de 2026

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

7 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • (1184)114-42

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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