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

ConditionsFrailty at Older Adults Mild Cognitive Impairment

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 volunteers

Qualifiers

be between 60 and 90 years old;

scored < 9/12 on the SPPB;

scored >18/30 on the MoCA;

scored >9/42 on the PFFS;

Disqualifiers

have magnetic resonance imaging (MRI) 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
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 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.

Treatment groups

45 Participants

are divided into 3 treatment groups

Group 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