rTMS Combined With Aerobic Exercise for Older Adults With Mild Cognitive Impairment and Comorbid Depression
torstai 11. kesäkuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
45
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Ya-Chu Chan, MS Candidate
- Puhelinnumero: +886-983-559-807
- Sähköposti: aya45285@gmail.com
Opiskelupaikat
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Taipei City
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Taipei, Taipei City, Taiwan, 112
- Rekrytointi
- Cheng Hsin General Hospital
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Ottaa yhteyttä:
- Ya-Chu Chan, MS Candidate
- Puhelinnumero: +886-983-559-807
- Sähköposti: aya45285@gmail.com
-
Ottaa yhteyttä:
- Kai-Chen Chan, MD
- Puhelinnumero: +886-983-559-807
- Sähköposti: aya45285@gmail.com
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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).
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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).
Muut nimet:
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Kokeellinen: 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).
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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).
Muut nimet:
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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Kokeellinen: 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).
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Montreal Cognitive Assessment (MoCA)
Aikaikkuna: 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)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Geriatric Depression Scale-15 (GDS-15)
Aikaikkuna: 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 depressive symptoms measured using the Geriatric Depression Scale-15 (GDS-15).
Higher scores indicate greater depressive symptom severity.
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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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Pittsburgh Sleep Quality Index (PSQI)
Aikaikkuna: 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 sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).
Lower scores indicate better sleep quality.
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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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Trail Making Test Part A (TMT-A)
Aikaikkuna: 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 attention and processing speed measured using the Trail Making Test Part A. Shorter completion times indicate better 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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Trail Making Test Part B (TMT-B)
Aikaikkuna: 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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Shorter completion times indicate better executive functioning and cognitive flexibility.
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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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California Verbal Learning Test-Short Form (CVLT-SF)
Aikaikkuna: 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 verbal learning and memory measured using the California Verbal Learning Test-Short Form (CVLT-SF).
Higher scores indicate better verbal learning and memory 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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Stroop Color-Word Test
Aikaikkuna: 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 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.
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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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Digit Span Forward Test
Aikaikkuna: 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 attention span and immediate verbal memory measured using the Digit Span Forward Test.
Higher scores indicate better attention and short-term memory 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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Digit Span Backward Test
Aikaikkuna: 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 working memory and executive function measured using the Digit Span Backward Test.
Higher scores indicate better working memory 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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Beck Depression Inventory-II (BDI-II)
Aikaikkuna: 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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Higher scores indicate greater depressive symptom severity.
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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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EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index)
Aikaikkuna: 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 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.
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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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World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Aikaikkuna: 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 quality of life measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF).
Higher scores indicate better quality of life.
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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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Chinese Aging Well Profile (CAWP)
Aikaikkuna: 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 subjective well-being measured using the Chinese Aging Well Profile (CAWP).
Higher scores indicate better subjective well-being.
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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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Timed Up and Go Test (TUG)
Aikaikkuna: 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 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.
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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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EuroQol Visual Analogue Scale Score (EQ-VAS)
Aikaikkuna: 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 self-rated health status measured using the EuroQol Visual Analogue Scale (EQ-VAS).
Higher scores indicate better perceived health status.
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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 gait speed (m/s)
Aikaikkuna: 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)
Aikaikkuna: 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 cadence measured in steps per minute.
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 stride length (m)
Aikaikkuna: 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 stride length measured in meters.
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 cost (%)
Aikaikkuna: 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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Percentage change in gait performance during dual-task walking relative to single-task walking.
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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 gait speed (m/s)
Aikaikkuna: 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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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)
Aikaikkuna: 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.
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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 stride length (m)
Aikaikkuna: 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.
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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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Kai-Chen Wang, MD, Cheng-Hsin General Hospital
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Tiistai 3. maaliskuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Perjantai 31. joulukuuta 2027
Opintojen valmistuminen (Arvioitu)
Perjantai 31. joulukuuta 2027
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Sunnuntai 7. kesäkuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 11. kesäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 17. kesäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 17. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 11. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Mielenterveyshäiriöt
- Käyttäytymisoireet
- Neurokognitiiviset häiriöt
- Kognitiohäiriöt
- Käyttäytyminen
- Kognitiivinen toimintahäiriö
- Masennus
- Henkilökohtainen tyytyväisyys
- Moottoritoiminta
- Liike
- Tuki- ja liikuntaelinten fysiologiset ilmiöt
- Tuki- ja hermosto- ja hermostofysiologiset ilmiöt
- Terapeuttiset lääkkeet
- Magneettikenttäterapia
- Käyttää
- Transkraniaalinen magneettinen stimulaatio
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