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A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults

Sponsor: The Hong Kong Polytechnic University • ClinicalTrials.gov ID: NCT07497334

Registry updated: 2026-09-30

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Description

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?

Interventions

Theta burst stimulation (Device)
Theta burst stimulation (TBS) will be administered using a figure-of-eight shaped cooling coil (Cool-B65 A/P), which generates auditory "clicks" for sham stimulation that are similar to those produced by active repetitive transcranial magnetic stimulation (rTMS). The placement of the coil will be guided by a navigation system (LOCALITE® TMS Navigator, Germany) using each participant's baseline T1-weighted Magnetic Resonance Imaging (MRI) scans. TBS is a powerful form of rTMS. Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress it.
Aerobic exercise (Behavioral)
The aerobic exercise sessions will include a 10-minute warm-up, followed by 40 minutes of brisk walking and/or stationary exercises without weights, and will conclude with a 10-minute cooldown. The intensity of the aerobic exercise will be monitored using heart rate, starting at 40% of the age-specific heart rate reserve (HRR), which is calculated using the formula: 207 - (0.7 x age). Over the initial 12 weeks, the intensity will be gradually increased until the HRR reaches 65%, and this level will be maintained until the end of the trial.

Eligibility criteria

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.

Conditions

Frailty at Older Adults Mild Cognitive Impairment

Locations

The Hong Kong Polytechnic University, Department of Rehabilitation Sciences — Hong Kong, Hong Kong

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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