The Effect of Fit Brains Training on Cognitive Performance in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Change from baseline in episodic memory as measured with the Rey Auditory Verbal Learning Test (RAVLT) at 8 weeks and 1-year follow-up
研究概览
简要总结
The investigators will conduct a 8-week proof-of-concept randomized controlled trial to provide preliminary evidence of efficacy of Fit Brains (Rosetta Stone Canada) training -- a mobile cognitive training program -- on cognitive and brain plasticity in older adults. The investigators will also explore whether Fit Brains training paired with a brief bout of exercise would enhance the potential cognitive benefits of Fit Brains. In addition, the investigators will explore the long-term effects of cognitive training by performing a 1-year follow-up measurement (i.e., 1-year after study completion).
详细描述
This study will look at the effect of FBT on cognitive function in older adults. Additionally, the investigators aim to explore whether a single bout of aerobic exercise prior to Fit Brains training would magnify the training effect on both cognitive and brain outcomes.
Objectives:
- To compare the effect of Fit Brains training (FBT) and the effect of a single bout of aerobic exercise prior to FBT (Ex-FBT) with a Balanced And Tone (BAT; control) program on cognitive performance in both older adults; 2) To explore the effect of FBT and Ex-FBT with BAT on brain structure and function i; 3) To explore whether the intervention effects (i.e., FBT and Ex-FBT) are moderated by cognitive status (i.e., MCI or not); 4) To explore whether Ex-FBT has additional benefits compared with FBT; and 5) To explore whether potential benefits are maintained at 1-year follow-up.
Research Method:
The investigators will conduct an 8-week proof-of-concept, assessor single-blinded randomized controlled trial (RCT) with 120 older adults (i.e., 40 in each experimental group). A subset of participants will perform MRI scans at baseline and 8-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 65 and 85 years
- •completed high school education
- •live in their own home
- •read, write, and speak English with acceptable visual and auditory acuity
- •have preserved general cognitive function as indicated by a Mini-Mental State Examination score
- •score > 6/8 on the Lawton and Brody Instrumental Activities of Daily Living Scale
- •are not expected to start or are stable on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine, etc.) during the 8-week study period
- •are able to walk independently;
- •are suitable to engage in 15-minutes of brisk walking based on the Physical Activity Readiness Questionnaire; and
- •provide a personally signed and dated informed consent document indicating that the individual has been informed of all pertinent aspects of the study.
排除标准
- •diagnosed with dementia of any type
- •clinically suspected to have neurodegenerative disease as the cause of MCI that is not AD, vascular dementia (VaD), or both (e.g. multiple sclerosis, Parkinson's disease, Huntington's disease, fronto-temporal dementia, etc.)
- •have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician
- •taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (i.e., typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.)
- •planning to participate, or already enrolled in, a concurrent clinical drug trial
- •Specific exclusion criteria for the MRI subset:
- •Participants do not meet the specific scanning requirements of the UBC MRI Research Centre. Specifically, the investigators will exclude anyone with: pacemaker, brain aneurysm clip, cochlear implant, surgery or tattoos within the past 6 weeks, electrical stimulator for nerves or bones, implanted infusion pump, history of any eye injury involving metal fragments, artificial heart valve, orthopedic hardware, other metallic prostheses, coil, catheter or filter in any blood vessel, ear or eye implant, bullets, or other metallic fragments.
研究组 & 干预措施
Fit Brains training
Both healthy participants and participants with Mild Cognitive Impairment (MCI) will be performing a cognitive training program (Fit Brains training) 6 hours a week for 8 weeks.
干预措施: Fit Brains Training (Behavioral)
Exercise + Fit Brains training
Both healthy participants and participants with Mild Cognitive Impairment (MCI) will be performing a combination of aerobic exercise and a cognitive training program (Fit Brains training) for 6 hours a week over 8 weeks.
干预措施: Exercise + Fit Brains Training (Behavioral)
Balanced And Tone
Both healthy participants and participants with Mild Cognitive Impairment (MCI) will complete 3 weekly training sessions of 1 hour for 8 weeks.
干预措施: Balanced And Tone (Behavioral)
结局指标
主要结局
Change from baseline in episodic memory as measured with the Rey Auditory Verbal Learning Test (RAVLT) at 8 weeks and 1-year follow-up
时间窗: Measured at baseline and at program completion (8 weeks), and 1-year follow-up
Measured by the Rey Auditory Verbal Learning Test (RAVLT)
次要结局
- Change from baseline in response inhibition as measured with the stroop test at 8 weeks and 1-year follow-up(Measured at baseline and at program completion (8 weeks), and 1-year follow-up)
- Change from baseline in set shifting as measured with the Trailmaking A and B test at 8 weeks and 1-year follow-up(Measured at baseline and at program completion (8 weeks), and 1-year follow-up)
- Change from baseline in working memory as measured with the digits forward and backward test at 8 weeks and 1-year follow-up(Measured at baseline and at program completion (8 weeks), and 1-year follow-up)
- Change from baseline in functional capacity as measured by the 6-Minute Walk Test at 8 weeks and 1-year follow-up(Measured at baseline and at program completion (8 weeks), and 1-year follow-up)
- Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) at 8 weeks(Measured at baseline and at program completion (8 weeks).)
- Change from baseline in brain function as measured by resting state functional MRI at 8 weeks(Measured at baseline and at program completion (8 weeks).)
- Change from baseline in brain structure as measured by structural MRI at 8 weeks(Measured at baseline and at program completion (8 weeks).)
研究者
Teresa Liu-Ambrose
Principal Investigator
University of British Columbia