Effects of Cognitive Training and Exercise on Cognitive Function in Older Women: the INCOGNITO Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Executive function and processing speed by the Trail Making Test (TMT)
研究概览
简要总结
Ageing exposes people to a progressive loss of cognitive and functional abilities, especially in women. The aim of the study is to investigate the effectiveness of different types of intervention, based on physical exercise and/or cognitive stimulation or training, on quality of life, cognition and mobility, on a population of older women.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Provision of the informed consent form
排除标准
- •Absolute contraindications to physical exercise (e.g. Nyha class iv heart failure, unstable angina, etc.)
- •Pregnancy
- •Severe cognitive impairment, defined as a MoCa score ≤ 12
- •Severe visual impairment or blindness
研究组 & 干预措施
Experimental 1 - Exercise plus cognitive training
In addition to the exercise program, participants will be given a series of cognitive exercises aimed at improving prospective memory through the performance of certain oral tasks, administered by a member of the research team. All cognitive exercises will be adapted to the cognitive abilities of the participants
干预措施: Exercise plus cognitive training (Behavioral)
Experimental 2 - Exercise plus cognitive stimulus
In addition to the exercise program, people randomised into this group will receive a short video lasting less than 10 minutes on their smartphone or tablet before the exercise session (or at home). At the end of the video, they will be asked to complete a 10-question questionnaire (also delivered via smartphone or tablet) with True or False answer options
干预措施: Exercise plus cognitive stimulus at home (Behavioral)
Active comparator - Exercise only
The exercise program (equal for all the study groups with the exercise intervention) includes 75-minute training sessions twice a week, for a total of 24 training sessions over 12 weeks. Each training session will be divided into a warm-up, training phase and cool-down, and will include aerobic exercises, resistance training, balance exercises, mobility exercises and stretching.
干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Control group
The subjects included in this group will not receive any specific treatment. They will receive advice on how to stay active at home and will undergo scheduled assessments.
结局指标
主要结局
Executive function and processing speed by the Trail Making Test (TMT)
时间窗: Baseline; end of the program (3-month); Follow-up (6-month)
TMT is neuropsychological test that assesses a person's cognitive function, specifically focusing on visual attention, processing speed, and executive function. The test consists of two parts, the score is based on the time it takes to complete each part, with shorter times indicating better performance.
次要结局
- Quality of life by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire(Baseline; end of the program (3-month); Follow-up (6-month))
- Quality of life assessed by the short-form 36 (SF-36) questionnaire(Baseline; end of the program (3-month); Follow-up (6-month))
- Cognition assessed by the Montreal Cognitive Assessment (MoCA)(Baseline; end of the program (3-month); Follow-up (6-month))
- Walking endurance assessed by the 6-Minute Walking Test (6MWT)(Baseline; end of the program (3-month); Follow-up (6-month))
- Physical performance assessed using the Short Physical Performance Battery (SPPB)(Baseline; end of the program (3-month); Follow-up (6-month))
- Manual grip strength using the Handgrip Test (HT).(Baseline; end of the program (3-month); Follow-up (6-month))
- Sleep quality and related disorders through the Pittsburgh Sleep Quality Index (PSQI)(Baseline; end of the program (3-month); Follow-up (6-month))
- Frontal and prefrontal cerebral perfusion using near-infrared spectroscopy (fNIRS).(Baseline; end of the program (3-month); Follow-up (6-month))
- Quality of life by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire(Baseline; end of the program (3-month); Follow-up (6-month))
- Quality of life assessed by the short-form 36 (SF-36) questionnaire(Baseline; end of the program (3-month); Follow-up (6-month))
- Cognition assessed by the Montreal Cognitive Assessment (MoCA)(Baseline; end of the program (3-month); Follow-up (6-month))
- Walking endurance assessed by the 6-Minute Walking Test (6MWT)(Baseline; end of the program (3-month); Follow-up (6-month))
- Physical performance assessed using the Short Physical Performance Battery (SPPB)(Baseline; end of the program (3-month); Follow-up (6-month))
- Manual grip strength using the Handgrip Test (HT).(Baseline; end of the program (3-month); Follow-up (6-month))
- Sleep quality and related disorders through the Pittsburgh Sleep Quality Index (PSQI)(Baseline; end of the program (3-month); Follow-up (6-month))
- Frontal and prefrontal cerebral perfusion using near-infrared spectroscopy (fNIRS).(Baseline; end of the program (3-month); Follow-up (6-month))
研究者
Fabio Manfredini
Full Professor
University Hospital of Ferrara