rTMS Combined With Aerobic Exercise for Older Adults With Mild Cognitive Impairment and Comorbid Depression
11 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Szacowany)
45
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Ya-Chu Chan, MS Candidate
- Numer telefonu: +886-983-559-807
- E-mail: aya45285@gmail.com
Lokalizacje studiów
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Taipei City
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Taipei, Taipei City, Tajwan, 112
- Rekrutacyjny
- Cheng Hsin General Hospital
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Kontakt:
- Ya-Chu Chan, MS Candidate
- Numer telefonu: +886-983-559-807
- E-mail: aya45285@gmail.com
-
Kontakt:
- Kai-Chen Chan, MD
- Numer telefonu: +886-983-559-807
- E-mail: aya45285@gmail.com
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-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Aged 65 to 90 years.
- Diagnosed with mild cognitive impairment (MCI) according to established clinical criteria.
- Presence of depressive symptoms as determined by clinical assessment and Beck Depression Inventory-II (BDI-II).
- Able to communicate and follow study instructions.
- Able to ambulate independently with or without an assistive device.
- Able to provide written informed consent.
Exclusion Criteria:
- Diagnosis of dementia.
- History of epilepsy or seizure disorder.
- Presence of metallic implants, pacemakers, cochlear implants, or other contraindications to transcranial magnetic stimulation.
- Major neurological disorders, including stroke, Parkinson's disease, traumatic brain injury, or other neurodegenerative diseases.
- Severe psychiatric disorders other than depression.
- Severe cardiovascular, musculoskeletal, or medical conditions that preclude participation in aerobic exercise.
- Severe visual or hearing impairments that interfere with cognitive assessment.
- Current participation in another intervention study.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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).
|
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).
Inne nazwy:
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Eksperymentalny: 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).
|
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).
Inne nazwy:
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).
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Eksperymentalny: 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).
|
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).
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).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Montreal Cognitive Assessment (MoCA)
Ramy czasowe: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
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Changes in global cognitive function measured using the Montreal Cognitive Assessment (MoCA).
Higher scores indicate better cognitive performance.
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Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Geriatric Depression Scale-15 (GDS-15)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
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Stroop Color-Word Test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
|
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EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index)
Ramy czasowe: 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)
|
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World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Ramy czasowe: 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)
|
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Chinese Aging Well Profile (CAWP)
Ramy czasowe: 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)
|
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Timed Up and Go Test (TUG)
Ramy czasowe: 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)
|
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EuroQol Visual Analogue Scale Score (EQ-VAS)
Ramy czasowe: 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)
|
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Dual-task gait speed (m/s)
Ramy czasowe: Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
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Changes in dual-task gait speed measured in meters per second (m/s).
Higher values indicate better gait performance.
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Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
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Dual-task cadence (steps/min)
Ramy czasowe: 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)
|
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Dual-task stride length (m)
Ramy czasowe: 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)
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Dual-task cost (%)
Ramy czasowe: 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)
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Single-task gait speed (m/s)
Ramy czasowe: 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.
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Baseline through 1-month follow-up (assessed at baseline, immediately after the 5-week intervention, and 1 month after intervention completion)
|
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Single-task cadence (steps/min)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Kai-Chen Wang, MD, Cheng-Hsin General Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
3 marca 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2027
Ukończenie studiów (Szacowany)
31 grudnia 2027
Daty rejestracji na studia
Pierwszy przesłany
7 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
11 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
17 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
17 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
11 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia psychiczne
- Objawy behawioralne
- Zaburzenia neurokognitywne
- Zaburzenia poznawcze
- Zachowanie
- Zaburzenia funkcji poznawczych
- Depresja
- Satysfakcja osobista
- Aktywność motoryczna
- Ruch
- Physiologiczne zjawiska mięśniowo -szkieletowe
- Zjawiska fizjologiczne mięśniowo -szkieletowe i nerwowe
- Lecznictwo
- Terapia pola magnetyczna
- Ćwiczenia
- Przezczaszkowa stymulacja magnetyczna
Inne numery identyfikacyjne badania
- (1184)114-42
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .