Status:
RECRUITING
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Frailty at Older Adults
Mild Cognitive Impairment
Eligibility:
All Genders
60-90 years
Phase:
NA
Brief 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, ...
Detailed Description
Objectives: To compare the effects of intermittent theta burst stimulation (iTBS) primed with continuous theta burst stimulation (cTBS), nonpriming iTBS, and sham stimulation on top of aerobic exercis...
Eligibility Criteria
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);
- cancer and undergo radiation therapy.
Key Trial Info
Start Date :
January 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07497334
Start Date
January 5 2025
End Date
June 30 2027
Last Update
March 27 2026
Active Locations (1)
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1
The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Hong Kong, Hong Kong