Health-related Quality of Life in Elderly Adults Following Physical Exercise and Cognitive Training: a Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Quality of Life assessed by the short-form 36 (SF-36) questionnaire
研究概览
简要总结
The aim of the study is to investigate the effectiveness of three 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 adults, who are most at risk of functional and cognitive decline
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female
- •Age ≥ 70 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
Structured Exercise Program + 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 TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Structured Exercise Program + Cognitive stimulus
In addition to the exercise program, people 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 TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Structured Exercise Program
The program 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.
The exercise program will be the same for all the three groups
干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
结局指标
主要结局
Quality of Life assessed by the short-form 36 (SF-36) questionnaire
时间窗: Baseline; end of the program (3-month); Follow-up (6-month)
This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks. For each specific domain, the score ranges from 0 (lowest quality of life) to 100 (highest quality of life).
Quality of Life assessed by the short-form 36 (SF-36) questionnaire
时间窗: Baseline; end of the program (3-month); Follow-up (6-month)
This is a generic questionnaire that contains 36 questions referring to 8 specific domains related to patient health over the previous 4 weeks. For each specific domain, the score ranges from 0 (lowest quality of life) to 100 (highest quality of life).
次要结局
- Cognitive capacity 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))
- 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 through the Pittsburgh Sleep Quality Index (PSQI)(Baseline; end of the program (3-month); Follow-up (6-month))
- Quality of life assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) questionnaire(Baseline; end of the program (3-month); Follow-up (6-month))
- Executive function and processing speed assessed by the Trail Making Test (TMT)(Baseline; end of the program (3-month); Follow-up (6-month))
- Timed Up-and-Go test(Baseline; end of the program (3-month); Follow-up (6-month))
研究者
Fabio Manfredini
Full Professor
University Hospital of Ferrara