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Brain stimulation plus aerobic exercise for older adults with cognitive frailty

Tests brain stimulation combined with exercise in older adults with cognitive frailty.

Key facts

Who runs it
The Hong Kong Polytechnic University
Where
Hong Kong1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Status
Recruiting
People taking part
45 people, planned
Started
5 Jan 2025
Expected to end
30 Jun 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Theta burst stimulation
  • Aerobic exercise
Record updated
30 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for older adults living in the community who are frail and have mild memory and thinking problems (cognitive frailty).

Age
60 to 90 years
Sex
All sexes
Disease stage
Cognitive frailty: score below 9/12 on the Short Physical Performance Battery, above 18/30 on the Montreal Cognitive Assessment, and above 9/42 on the Pictorial Fit-Frail Scale. Able to walk up to four meters, with or without walking aids.
Earlier treatment
People who take, or have taken, medicines that may affect thinking or physical function (for example psychotropic medicines) cannot join.

Main reasons for not taking part

  • Reasons you cannot have an MRI scan, magnetic brain stimulation (TMS) or aerobic exercise
  • Dementia, Parkinson's, Alzheimer's disease, ALS or stroke
  • Living in a nursing home or other care facility
  • Past falls due to loss of consciousness (carotid sinus sensitivity)
  • Cancer with ongoing radiation therapy

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • be between 60 and 90 years old
  • scored < 9/12 on the Short Physical Performance Battery
  • scored >18/30 on the Montreal Cognitive Assessment
  • scored >9/42 on the Pictorial Fit-Frail Scale
  • 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

Who cannot take part

  • 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
  • be diagnosed with neurodegenerative conditions (i.e., dementia, Parkinson's, Alzheimer's disease, Amyotrophic lateral sclerosis, and stroke)
  • cancer and undergo radiation therapy
  • have magnetic resonance imaging contraindications
  • have aerobic exercise contraindications
  • have transcranial magnetic stimulation contraindications
  • live in a nursing home or other care facilities/institutions
  • have a history indicative of carotid sinus sensitivity (i.e., falls due to loss of consciousness)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 60 and 90 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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?

The 3 groups in the trial

  • cTBS+iTBS, in addition to aerobic exerciseTreatment being tested

    Participants will receive 600-pulse continuous theta burst stimulation (cTBS) at the intensity of 80% resting motor threshold (RMT) as the priming, followed by 600-pulse intermittent theta burst stimulation (iTBS) at the intensity of 80% RMT (i.e., priming iTBS). The stimulation will be delivered 3 sessions per week, lasting for 3 months. Participants will receive a 60-minute aerobic exercise after each stimulation session, lasting for 6 months

    Treatment: Theta burst stimulation and Aerobic exercise

  • Sham cTBS + iTBS, in addition to aerobic exerciseExisting treatment, for comparison

    Participants will receive sham 600-pulse cTBS at the intensity of 80% RMT as the priming, followed by 600-pulse iTBS at the intensity of 80% RMT (i.e., priming iTBS). The stimulation will be delivered 3 sessions per week, lasting for 3 months. Participants will receive a 60-minute aerobic exercise after each stimulation session, lasting for 6 months

    Treatment: Theta burst stimulation and Aerobic exercise

  • Sham cTBS + sham iTBS, in addition to aerobic exerciseSham treatment, for comparison

    Participants will receive sham 600-pulse cTBS at the intensity of 80% RMT as the priming, followed by sham 600-pulse iTBS at the intensity of 80% RMT (i.e., priming iTBS). The stimulation will be delivered 3 sessions per week, lasting for 3 months. Participants will receive a 60-minute aerobic exercise after each stimulation session, lasting for 6 months

    Treatment: Theta burst stimulation and Aerobic exercise

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Plain-language title
Brain stimulation plus aerobic exercise for older adults with cognitive frailtyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT07497334, who can take part
Record updated
30 September 2026