A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorThe Hong Kong Polytechnic University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
have magnetic resonance imaging 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);
Trial design
Design model
Parallel
Treatments tested in this trial
Theta burst stimulation
DeviceTheta 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
BehavioralThe 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: cTBS+iTBS, in addition to aerobic exerciseExperimental treatment 2 interventions
Group B: Sham cTBS + iTBS, in addition to aerobic exerciseActive comparator 2 interventions
Group C: Sham cTBS + sham iTBS, in addition to aerobic exerciseSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov