Depressive Symptoms, Mild Cognitive Impairment (MCI)
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise, Dual-Task Walking, Timed Up and Go, Cognitive Function, Older Adults, Life Satisfaction, Gait Performance, rTMS
Brief summary
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.
Detailed description
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.
Interventions
DEVICERepetitive 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).
BEHAVIORALAerobic 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).
DEVICESham 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).
Sponsors
Cheng-Hsin General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcome assessors will be blinded to group allocation. Sham stimulation will be delivered using a figure-of-eight coil positioned at a 90-degree angle to the scalp and approximately 3 cm away from the scalp surface to mimic the auditory and sensory experience of active stimulation without producing effective cortical stimulation.
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geriatric Depression Scale-15 (GDS-15) | 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. |
| Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Trail Making Test Part A (TMT-A) | 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. |
| Trail Making Test Part B (TMT-B) | 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. |
| California Verbal Learning Test-Short Form (CVLT-SF) | 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. |
| Stroop Color-Word Test | 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. |
| Digit Span Forward Test | 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. |
| Digit Span Backward Test | 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. |
| Beck Depression Inventory-II (BDI-II) | 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. |
| EuroQol Five-Dimension Five-Level Questionnaire Index Score (EQ-5D-5L Index) | 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. |
| World Health Organization Quality of Life-BREF (WHOQOL-BREF) | 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. |
| Chinese Aging Well Profile (CAWP) | 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. |
| Timed Up and Go Test (TUG) | 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. |
| EuroQol Visual Analogue Scale Score (EQ-VAS) | 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. |
| Dual-task gait speed (m/s) | 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. |
| Dual-task cadence (steps/min) | 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. |
| Dual-task stride length (m) | 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. |
| Dual-task cost (%) | 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. |
| Single-task gait speed (m/s) | 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. |
| Single-task cadence (steps/min) | 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. |
| Single-task stride length (m) | 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. |
Countries
Taiwan
Contacts
CONTACTYa-Chu Chan, MS Candidate
PRINCIPAL_INVESTIGATORKai-Chen Wang, MD
Cheng-Hsin General Hospital
Outcome results
None listed