Effectiveness Of Computer-Based Cognitive Training Combined With Aerobic Training in Age-Related Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment test
研究概览
简要总结
Background: Ageing is frequently accompanied by physiological changes that might result in a deterioration in physical and cognitive abilities, which frequently leads to institutionalization or the loss of autonomy. Mild cognitive impairment (MCI) is an intermediate state between normal cognitive aging and early dementia, the optimal period to intervene with preventive strategies and early treatments. Thus, the current study intends to investigate the effects of aerobic and computer-based cognitive training on age-related cognitive decline.
Methods: This is a single-blinded, randomized controlled trial. Elderly patients with mild cognitive impairment (n = 60) will be randomized to 2 arms and treated for 12 weeks: arm 1 (aerobic exercise and computerized cognitive training) and arm 2 (Placebo; will not receive any intervention). Outcome measure used were Montreal Cognitive Assessment (MOCA) test, Barthel Index (BI) and short form survey-12 (SF-12).
Statistical Analysis: To compare the baseline characteristics and outcome variables between the two groups, independent t-tests was employed. A two-way repeated measures ANOVA was utilized to determine the interaction effect of time (baseline, post-treatment, and follow-up) and group (intervention vs. control) on the outcome measures.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Who fulfilled MCI criteria [10]: (1) subjective cognitive concerns; (2) objective cognitive impairment in memory, executive function, attention, and/or language; (3) preserved activities of daily living; and (4) absence of dementia
- •Had adequate visual, auditory, and fine motor skills.
排除标准
- •Major depression (scored > 9 in the Geriatric Depression Scale, GDS-15) [11]
- •Schizophrenia
- •Substance abuse
- •parkinsonism
- •conditions affecting gait (eg, severe osteoarthritis, previous stroke),
- •participated in any cognitive training program during last 6 months > 2 h/week
- •ACSM contraindications to exercise or other factors that make exercise impossible or unsafe
- •cognitive enhancers, or anticholinergics
结局指标
主要结局
Montreal Cognitive Assessment test
时间窗: at the baseline (day 0), at the end of the treatment (after 12 weeks) as well as after 4 weeks of follow up (after 16 weeks)
A commonly used test to assess different cognitive domains, including short-term memory recall, visuospatial abilities, executive functions, attention, concentration, and working memory. MoCA scores range between 0 and 30 where the highest score is considered to be normal.
Barthel Index
时间窗: at the baseline (day 0), at the end of the treatment (after 12 weeks) as well as after 4 weeks of follow up (after 16 weeks)
This index was used to measure an individual's capacity to perform ten activities of daily living, reflecting their functional independence. Total possible scores range from 0 - 20, with lower scores indicating increased disability.
Short form survey-12
时间窗: at the baseline (day 0), at the end of the treatment (after 12 weeks) as well as after 4 weeks of follow up (after 16 weeks)
A generic measure utilized to assess the health-related quality of life, covering both physical and mental health dimensions. The summary scores range from a minimum of 0 to a maximum of 100. Higher the SF-12 scores, indicates the higher (better) quality of life.
次要结局
未报告次要终点
研究者
Dr. Mohammad Abu Shaphe
Associate Professor
University of Jazan