Brain stimulation plus aerobic exercise to improve thinking and mobility in cognitively frail older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. be between 60 and 90 years old;
2. scored \< 9/12 on the Short Physical Performance Battery;
3. scored \>18/30 on the Montreal Cognitive Assessment;
4. scored \>9/42 on the Pictorial Fit-Frail Scale;
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 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-day exercise test to see how brain and body react in epilepsy, cognitive disorders, Parkinson's, dementia, and related conditions

  A one-day study tests how an acute bout of exercise changes brain function and bodily signals in people with certain neurological conditions compared with healthy individuals.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT07883720

• Choose Myself (Before) Losing Myself

  We’re testing an educational interactive booklet to help people with dementia or memory problems think about future medical decisions and start conversations with family or caregivers.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07846566

• Gut and Oral Microbiome and Cognitive Health in Aging

  This study tests whether differences in gut and mouth bacteria are linked to cognitive health in adults across ages and cognitive status.

  Recruiting University of South Florida · Tampa, Florida · NCT07799402

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• AI-supported sleep program for people with mild cognitive impairment or dementia

  A small randomized trial tests an AI-assisted behavioral sleep program to help people with mild cognitive impairment or mild dementia who have sleep problems.

  Recruiting The Hong Kong Polytechnic University · Kowloon, Hung Hom · NCT07784946

• Binaural beats for cognitive function in older adults with mild cognitive impairment in nursing homes

  This study tests whether listening to 10-Hz binaural beats for 30 minutes daily for 14 days can help cognitive function in older adults with mild cognitive impairment living in nursing homes.

  Recruiting at 3 sites China Medical University, China · Shenyang, Liaoning and 2 other locations · NCT07735910

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.