NCT07497334 A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
| NCT ID | NCT07497334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Frailty at Older Adults |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-01-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-01-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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?
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.
Contact & Investigator
Chun Liang HSU, PhD
PRINCIPAL INVESTIGATOR
The Hong Kong Polytechnic University
Frequently Asked Questions
Who can join the NCT07497334 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 90 Years, studying Frailty at Older Adults. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07497334 currently recruiting?
Yes, NCT07497334 is actively recruiting participants. Contact the research team at 24144838r@connect.polyu.hk for enrollment information.
Where is the NCT07497334 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07497334 clinical trial?
NCT07497334 is sponsored by The Hong Kong Polytechnic University. The principal investigator is Chun Liang HSU, PhD at The Hong Kong Polytechnic University. The trial plans to enroll 45 participants.