A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults (NCT07497334) | Clinical Trial Compass
RecruitingNot Applicable
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Hong Kong45 participantsStarted 2025-01-05
Plain-language summary
The goal of this clinical trial is to explore the effects of intermittent theta burst stimulation (iTBS) primed with theta burst stimulation (cTBS), on top of aerobic exercise, on cognitive function, mobility, and brain activity in older adults with cognitive frailty. Understanding these effects will help us develop intervention models that benefit cognitively frail older adults. The main questions it aims to answer are:
1. Does the combination of iTBS primed with cTBS and aerobic exercise lead to greater improvements in cognition and mobility in older adults with cognitive frailty compared to non-priming iTBS and sham stimulation?
2. What are the neural mechanisms responsible for the improvements in cognition and mobility associated with the combination of iTBS primed with cTBS and aerobic exercise in older adults with cognitive frailty?
Who can participate
Age range60 Years – 90 Years
SexALL
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Inclusion criteria
✓. be between 60 and 90 years old;
✓. scored \< 9/12 on the SPPB;
✓. scored \>18/30 on the MoCA;
✓. scored \>9/42 on the PFFS;
✓. lived in the community;
✓. be able to ambulate up to four meters with or without assistive devices;
✓. be able to provide written informed consent on their own behalf;
✓. can understand verbal and written Cantonese and/or English.
Exclusion criteria
✕. have magnetic resonance imaging (MRI) contraindications;
✕. have aerobic exercise contraindications;
✕. have transcranial magnetic stimulation contraindications;
. be diagnosed with neurodegenerative conditions (i.e., dementia, Parkinson's, Alzheimer's disease, Amyotrophic lateral sclerosis, and stroke);
✕. live in a nursing home or other care facilities/institutions;
✕. 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.
✕. have a history indicative of carotid sinus sensitivity (i.e., falls due to loss of consciousness);