An interventional study of Theta burst stimulation and Aerobic exercise in Frailty at Older Adults and Mild Cognitive Impairment, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
Among 21 studies in Cognitive Dysfunction by The Hong Kong Polytechnic University — 11 open to participants now, 11 under way, none of them phase 3. Cognitive Dysfunction · The Hong Kong Polytechnic University.
Among the 21 studies in Cognitive Dysfunction by The Hong Kong Polytechnic University, this one is the 18th largest by planned enrollment of the 19 interventional ones, is one of 6 that started in 2025, is one of 19 with no phase, reaches primary completion later than 9 of the 10 other live ones, and was the 19th registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 45 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →11 of the 21 studies in Cognitive Dysfunction by The Hong Kong Polytechnic University are open now, in 1 country. Each count lists the studies.
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 60 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →21 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 6 started in 2025.
Median enrollment 66 across the 19 interventional studies, 70 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
5 of the studies in Cognitive Dysfunction by The Hong Kong Polytechnic University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07496359The Hong Kong Polytechnic UniversityDyadic Management Intervention in Older People With Co-occurring Cognitive Impairment and Diabetes as a Supplementary Approach to Chronic Diseases Self-Management Program | 2026-11 |
| NCT07733726The Hong Kong Polytechnic UniversityOral Motor and Cognitive Dual-Task Training (OMCDT) Program for Improving Oral and Cognitive Functions Among People With Oral Frailty | 2026-12-15 |
| NCT06791720The Hong Kong Polytechnic UniversityEffects of Music-with-Movement on Cognitive and Physical Performance of People with Potentially Reversible Cognitive Frailty: a Randomised Controlled Trial | 2027-04-30 |
| NCT07497334The Hong Kong Polytechnic UniversityA Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults | 2027-06-30 |
| NCT07784946The Hong Kong Polytechnic UniversityA Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia | 2027-07 |
Among the 21 studies in Cognitive Dysfunction by The Hong Kong Polytechnic University, from their registry updates:
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:
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 exercise in terms of improving cognitive function, mobility, brain structure, and brain function in older adults with cognitive frailty.
Hypothesis to be tested: We hypothesize that iTBS primed with cTBS can maximize the induction of therapeutically beneficial metaplasticity, and that this will be reflected in improved brain structure and brain function, thereby enabling superior cognitive function and mobility improvement in older adults with cognitive frailty.
Design and subjects: A randomized controlled trial involving 60 older adults with cognitive frailty.
Study instruments: Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI).
Interventions: Participants will be randomly allocated to receive a 39-session intervention with different TBS protocols (i.e., cTBS+iTBS, sham cTBS+iTBS, and sham cTBS+sham iTBS), delivered 3 times per week for 3 months. All participants will receive 60 minutes of aerobic exercise after each stimulation session for 6 months.
Main outcome measures: comprehensive neuropsychological battery covering major executive function (i.e., selective attention/response inhibition, psychomotor speed, set shifting), working memory, and verbal fluency; (2) mobility function evaluated via SPPB, Timed-Up-and-GO (TUG) test, functional gait analysis (i.e., gait speed, gait variability).
Secondary outcomes: underlying neural mechanisms of intervention-induced benefits will be assessed via functional and structural magnetic resonance imaging.
Data analysis: Analysis of variance (ANOVA)
The criteria were revised on the registry on Sep 25, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Theta burst stimulation · Behavioral: Aerobic exercise
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
Device: Theta burst stimulation · Behavioral: Aerobic exercise
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
Device: Theta burst stimulation · Behavioral: Aerobic exercise
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.
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.
Montreal Cognitive Assessment
General cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The total MoCA score ranges from 0 to 30, with higher scores indicating better cognitive performance
Time frame: Baseline, 3 months, and 6 months
Short Physical Performance Battery
Mobility will be assessed using the Short Physical Performance Battery (SPPB). The SPPB evaluates balance, gait speed, and chair stand performance, with total scores ranging from 0 to 12. Higher scores indicate better mobility
Time frame: Baseline, 3 months, and 6 months
Pictorial Fit-Frail Scale
Frailty in older adults will be assessed using the Pictorial Fit-Frail Scale (PFFS). The PFFS evaluates 14 health domains, with total scores ranging from 0 to 43. Higher scores indicate a greater severity of frailty.
Time frame: Baseline, 3 months, and 6 months
Six Minutes Walking Test
The Six-Minute Walk Test (6MWT) is a practical, self-paced clinical test that measures the total distance an individual can walk on a flat, hard surface in six minutes. A longer distance walked reflects a higher level of functional mobility.
Time frame: Baseline, 3 months, and 6 months
Timed-Up-and-Go Test
The Timed Up and Go (TUG) test is a standardized assessment used to evaluate mobility and gait. A longer completion time reflects poorer physical mobility.
Time frame: Baseline, 3 months, and 6 months
Task Switch Test
The Task Switching Test is a standardized assessment used to evaluate executive function. A higher accuracy rate and a shorter reaction time reflect superior executive performance
Time frame: Baseline, 3 months, and 6 months
Digit Span Test
The Digit Span Test is a standardized neuropsychological assessment used to evaluate attention and working memory. The test comprises two components: Digits Forward and Digits Backward. A higher cumulative score reflects better overall performance. Additionally, a smaller discrepancy score (calculated as the forward span minus the backward span) represents superior cognitive manipulation and updating ability.
Time frame: Baseline, 3 months, and 6 months
Digit Symbol Substitution Test
The Digit Symbol Substitution Test (DSST) is a standardized neuropsychological instrument used to evaluate cognitive processing speed and executive function. The total score is determined by the number of correctly completed items within a specified time limit, with higher scores reflecting superior cognitive performance.
Time frame: Baseline, 3 months, and 6 months
Stroop Test
The Stroop Test is a standardized neuropsychological assessment used to evaluate executive function, particularly inhibitory control. The completion time for each condition is recorded as the score, with shorter completion times reflecting superior executive performance.
Time frame: Baseline, 3 months, and 6 months
Trail Making Test
The Trail Making Test will comprise Part A and Part B. In Part A, participants are instructed to connect numbers in sequential order (e.g., drawing a line from 1 to 2, 2 to 3, 3 to 4, etc.) while being timed. In Part B, participants are instructed to connect, in order, 25 encircled numbers and letters alternately (e.g., 1-A-2-B-3-C) while being timed. A longer time represents worse executive function.
Time frame: Baseline, 3 months, and 6 months
30-second sit to stand
Functional mobility and lower-limb functional strength will be measured via the 30-Second Chair Stand Test (30CST). Participants stand up and sit down as rapidly and safely as possible for 30 seconds, where a higher repetition score indicates greater functional mobility.
Time frame: Baseline, 3 months, and 6 months
cortical and subcortical volume
Cortical and subcortical volume will be examined in all participants using MRI. Participants will undergo structural MRI on the 3T Siemens scanner at the University Research Facility in Behavioral and Systems Neuroscience. Participants will complete T1 and T2 high resolution anatomical scans.
Time frame: Baseline, 3 months, and 6 months
Resting State-Functional Connectivity-Functional MRI
Participants will be instructed to rest with eyes open for approximately 12 minutes. This will allow the investigators to examine activation in the resting state network.
Time frame: Baseline, 3 months, and 6 months
Physical Activity Scale for the Elderly
Physical activity will be assessed by Physical Activity Scale for the Elderly (PASE), where a higher score indicates a higher level of physical activity.
Time frame: Baseline, 3 months, and 6 months
Geriatric Depression Scale
Depression will be measured by Geriatric Depression Scale (GDS), where a higher score indicates a higher level of depressive symptoms
Time frame: Baseline, 3 months, and 6 months
Fatigue Severity Scale
Physical fatigue will be measured by Fatigue Severity Scale (FSS), where a higher score indicates more severe fatigue
Time frame: Baseline, 3 months, and 6 months
Functional Comorbidity Index
Total number of comorbid conditions will be assessed through the Functional Comorbidity Index (FCI), where a higher score indicates a greater comorbidity burden.
Time frame: Baseline, 3 months, and 6 months
Functional Activities Questionnaire
The difficulties in activities of daily living will be assessed using the Functional Activities Questionnaire (FAQ), with higher scores reflecting severe difficulty in performing daily tasks.
Time frame: Baseline, 3 months, and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 29 months is close to that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The Hong Kong Polytechnic University →