A Novel Multi-Modal Approach to Promote Functional Outcomes in Cognitively Frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
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:
- 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?
- 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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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);
- •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.
研究组 & 干预措施
cTBS+iTBS, in addition to aerobic exercise
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
干预措施: Theta burst stimulation (Device)
cTBS+iTBS, in addition to aerobic exercise
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
干预措施: Aerobic exercise (Behavioral)
Sham cTBS + iTBS, in addition to 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
干预措施: Theta burst stimulation (Device)
Sham cTBS + iTBS, in addition to 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
干预措施: Aerobic exercise (Behavioral)
Sham cTBS + sham iTBS, in addition to 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
干预措施: Theta burst stimulation (Device)
Sham cTBS + sham iTBS, in addition to 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
干预措施: Aerobic exercise (Behavioral)
结局指标
主要结局
Short Physical Performance Battery
时间窗: Baseline, 3 months, and 6 months
Mobility will be measured by Short Physical Performance Battery
Pictorial Fit-Frail Scale
时间窗: Baseline, 3 months, and 6 months
The assessment of frailty in older adults will be conducted using the Pictorial Fit-Frail Scale.
Montreal Cognitive Assessment
时间窗: Baseline, 3 months, and 6 months
General cognitive function will be measured by Montreal Cognitive Assessment
次要结局
- Six Minutes Walking Test(Baseline, 3 months, and 6 months)
- Timed-Up-and-Go Test(Baseline, 3 months, and 6 months)
- Task Switch Test(Baseline, 3 months, and 6 months)
- Digit Span Test(Baseline, 3 months, and 6 months)
- Digit Symbol Substitution Test(Baseline, 3 months, and 6 months)
- Stroop Test(Baseline, 3 months, and 6 months)
- Trail Making Test(Baseline, 3 months, and 6 months)
- Sit to stand(Baseline, 3 months, and 6 months)
- cortical and subcortical volume(Baseline, 3 months, and 6 months)
- Resting State-Functional Connectivity-Functional MRI(Baseline, 3 months, and 6 months)
- Physical Activity Scale for the Elderly(Baseline, 3 months, and 6 months)
- Geriatric Depression Scale(Baseline, 3 months, and 6 months)
- Fatigue Severity Scale(Baseline, 3 months, and 6 months)
- Functional Comorbidity Index(Baseline, 3 months, and 6 months)
- Functional Activities Questionnaire(Baseline, 3 months, and 6 months)
研究者
HSU Chun Liang
assistant professor
The Hong Kong Polytechnic University