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

11 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

45

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Ya-Chu Chan, MS Candidate
  • Número de telefone: +886-983-559-807
  • E-mail: aya45285@gmail.com

Locais de estudo

  • Taiwan
    • Taipei City
      • Taipei, Taipei City, Taiwan, 112
        • Recrutamento
        • Cheng Hsin General Hospital
        • Contato:
          • Ya-Chu Chan, MS Candidate
          • Número de telefone: +886-983-559-807
          • E-mail: aya45285@gmail.com
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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).
Outros nomes:
  • 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).
Outros nomes:
  • rTMS
Comportamental: 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).
Comportamental: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Montreal Cognitive Assessment (MoCA)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Geriatric Depression Scale-15 (GDS-15)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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 (%)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cheng-Hsin General Hospital

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de março de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

7 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • (1184)114-42

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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