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Recruiting NCT07497334

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

No phase Interventional Frailty at Older Adults Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Theta burst stimulation, Aerobic exercise.
Who it may be relevant to
Registry conditions: Frailty at Older Adults, Mild Cognitive Impairment. Basic parameters: 60 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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?

Detailed description

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)

Interventions

  • Device Theta burst stimulation
    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 sti
  • Behavioral Aerobic exercise
    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 w

Primary outcome measures

  • Montreal Cognitive Assessment [Time frame: Baseline, 3 months, and 6 months]
  • Short Physical Performance Battery [Time frame: Baseline, 3 months, and 6 months]
  • Pictorial Fit-Frail Scale [Time frame: Baseline, 3 months, and 6 months]
Secondary outcome measures (12)
  • Six Minutes Walking Test [Time frame: Baseline, 3 months, and 6 months]
  • Timed-Up-and-Go Test [Time frame: Baseline, 3 months, and 6 months]
  • Task Switch Test [Time frame: Baseline, 3 months, and 6 months]
  • Digit Span Test [Time frame: Baseline, 3 months, and 6 months]
  • Digit Symbol Substitution Test [Time frame: Baseline, 3 months, and 6 months]
  • Stroop Test [Time frame: Baseline, 3 months, and 6 months]
  • Trail Making Test [Time frame: Baseline, 3 months, and 6 months]
  • Sit to stand [Time frame: Baseline, 3 months, and 6 months]
  • cortical and subcortical volume [Time frame: Baseline, 3 months, and 6 months]
  • Resting State-Functional Connectivity-Functional MRI [Time frame: Baseline, 3 months, and 6 months]
  • Physical Activity Scale for the Elderly [Time frame: Baseline, 3 months, and 6 months]
  • Geriatric Depression Scale [Time frame: Baseline, 3 months, and 6 months]

Eligibility criteria

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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);
  • live in a nursing home or other care facilities/institutions;
  • 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.
  • have a history indicative of carotid sinus sensitivity (i.e., falls due to loss of consciousness);
  • cancer and undergo radiation therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University, Department of Rehabilitation Sciences — Hong Kong

Identifiers

NCT: NCT07497334 · HSEARS20240614001 · P0048639

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗