Brain stimulation plus aerobic exercise to improve thinking and mobility in cognitively frail older adults
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
This project will test whether adding short bursts of brain stimulation to regular aerobic exercise helps older adults with cognitive frailty improve thinking and walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07497334 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll 60 community-dwelling older adults with cognitive frailty and randomly assign them to one of three theta burst stimulation protocols (cTBS priming followed by iTBS, non-priming iTBS, or sham stimulation) delivered three times per week for three months (39 sessions). After each stimulation session participants will complete 60 minutes of supervised aerobic exercise and the exercise program continues across the intervention period up to six months. Primary outcomes include a comprehensive neuropsychological battery targeting executive function, working memory, and verbal fluency, together with mobility tests (SPPB, Timed-Up-and-Go, functional gait analysis). MRI and TMS measures of brain structure and function will be collected to explore neural mechanisms linking brain changes to improvements in cognition and mobility.
Who should consider this trial
Good fit: Ideal candidates are community-dwelling adults aged 60–90 with cognitive frailty (SPPB <9/12, MoCA >18/30, PFFS >9/42), able to ambulate four meters, provide written informed consent, and understand Cantonese or English.
Not a fit: People with diagnosed neurodegenerative diseases (for example dementia, Parkinson's disease, stroke), contraindications to MRI, TMS, or aerobic exercise, residents of nursing homes, or those taking medications known to affect cognition are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this combined brain stimulation and aerobic exercise approach could produce larger and more durable improvements in thinking, walking, and brain connectivity for cognitively frail older adults.
How similar studies have performed: Prior research shows that theta burst stimulation and aerobic exercise can each improve cognition and mobility, but combining cTBS-primed iTBS with a supervised aerobic program is relatively novel and has limited direct evidence of superiority.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. be between 60 and 90 years old; 2. scored \< 9/12 on the SPPB; 3. scored \>18/30 on the MoCA; 4. scored \>9/42 on the PFFS; 5. lived in the community; 6. be able to ambulate up to four meters with or without assistive devices; 7. be able to provide written informed consent on their own behalf; 8. can understand verbal and written Cantonese and/or English. Exclusion Criteria: 1. have magnetic resonance imaging (MRI) contraindications; 2. have aerobic exercise contraindications; 3. have transcranial magnetic stimulation contraindications; 4. be diagnosed with neurodegenerative conditions (i.e., dementia, Parkinson's, Alzheimer's disease, Amyotrophic lateral sclerosis, and stroke); 5. live in a nursing home or other care facilities/institutions; 6. bed taking fixed dose of medication or had been taking medications known to potentially affect cognitive and physical function (e.g., psychotropic medications), as identified through a review of their medication lists recorded in the health software. Medications were categorized by properties (e.g., antipsychotics, antidepressants, etc.) to inform eligibility decisions. 7. have a history indicative of carotid sinus sensitivity (i.e., falls due to loss of consciousness); 8. cancer and undergo radiation therapy.
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University, Department of Rehabilitation Sciences — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chun Liang HSU, PhD — The Hong Kong Polytechnic University
- Study coordinator: JINGYI WU, MSc
- Email: 24144838r@connect.polyu.hk
- Phone: +85260730847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.