Actively Recruiting
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Led by The Hong Kong Polytechnic University · Updated on 2026-03-27
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how a combination of brain stimulation and aerobic exercise can improve thinking skills, mobility, and brain function in older adults with cognitive frailty. This trial compares different types of theta burst stimulation, including intermittent theta burst stimulation (iTBS) primed with continuous theta burst stimulation (cTBS), non-priming iTBS, and sham stimulation, to understand their effects on brain structure and function. The study aims to identify how these treatments impact cognition and movement and the brain mechanisms behind these changes. Participants will be randomly assigned to one of three groups receiving different theta burst stimulation protocols three times a week for three months: cTBS followed by iTBS, sham cTBS followed by iTBS, or sham cTBS followed by sham iTBS. After each stimulation session, all participants will take part in 60-minute aerobic exercise sessions for a total of six months. The brain stimulation will be delivered using a special coil guided by MRI scans to target specific brain areas. During the study, participants will undergo tests at the start, three months, and six months to assess their cognitive abilities, mobility, and brain activity. These include memory and attention tests, physical performance measures like gait speed and balance, and brain imaging scans. Researchers will also monitor physical activity levels, mood, fatigue, and daily functioning. The total involvement includes 39 stimulation sessions and ongoing exercise, with comprehensive evaluations throughout the study period.
CONDITIONS
Brief Title
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 60 and 90 years old
- Score less than 9 out of 12 on the Short Physical Performance Battery (SPPB)
- Score more than 18 out of 30 on the Montreal Cognitive Assessment (MoCA)
- Score more than 9 out of 42 on the Pictorial Fit-Frail Scale (PFFS)
- Live in the community (not in nursing homes or care facilities)
- Be able to walk up to four meters with or without assistive devices
- Be able to provide written informed consent on their own behalf
- Understand verbal and written Cantonese and/or English
You will not qualify if you...
- Have contraindications for magnetic resonance imaging (MRI)
- Have contraindications for aerobic exercise
- Have contraindications for transcranial magnetic stimulation (TMS)
- Have diagnosed neurodegenerative conditions such as dementia, Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis, or stroke
- Live in nursing homes or other care institutions
- Be bedridden or taking medications that may affect cognitive and physical function, including psychotropic drugs
- Have a history of carotid sinus sensitivity causing falls due to loss of consciousness
- Have cancer and currently undergoing radiation therapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months for stimulation; aerobic exercise continues for 6 months
Participants receive theta burst stimulation sessions 3 times per week for 3 months. After each stimulation session, participants complete 60 minutes of aerobic exercise. This combined intervention aims to improve cognitive function and mobility.
3 visits per week for 3 months, each including stimulation and aerobic exercise
Duration - 3 additional months after stimulation ends, totaling 6 months
Participants continue aerobic exercise sessions up to 6 months to support ongoing benefits in cognitive function and mobility.
Continued aerobic exercise sessions 3 times per week for 3 more months
Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Hong Kong, Hong Kong
Actively Recruiting
Research Team
J
JINGYI WU, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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