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

11. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

45

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Ya-Chu Chan, MS Candidate
  • Telefonní číslo: +886-983-559-807
  • E-mail: aya45285@gmail.com

Studijní místa

  • Tchaj-wan
    • Taipei City
      • Taipei, Taipei City, Tchaj-wan, 112
        • Nábor
        • Cheng Hsin General Hospital
        • Kontakt:
          • Ya-Chu Chan, MS Candidate
          • Telefonní číslo: +886-983-559-807
          • E-mail: aya45285@gmail.com
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Přístroj: 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).
Ostatní jména:
  • rTMS
Experimentální: 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).
Přístroj: 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).
Ostatní jména:
  • rTMS
Behaviorální: 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).
Experimentální: 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).
Behaviorální: 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).
Přístroj: 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).

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Montreal Cognitive Assessment (MoCA)
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Geriatric Depression Scale-15 (GDS-15)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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 (%)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Cheng-Hsin General Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Kai-Chen Wang, MD, Cheng-Hsin General Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. března 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

7. června 2026

První předloženo, které splnilo kritéria kontroly kvality

11. června 2026

První zveřejněno (Aktuální)

17. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

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