A Home-based e-Health Intervention of Demanding Cognitive Exercise for the Improvement of Cardiorespiratory Fitness and Cognitive Function in the Elderly: MOVI-ageing.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Cognitive decline
研究概览
简要总结
This protocol study aims to evaluate the efficacy of the MOVI-ageing intervention, a complex home-based eHealth intervention of cognitive-demanding exercise for the elderly, in improving: global cognitive function and basic cognitive functions and cardiorespiratory and muscular fitness.
In addition, this sudy aims to evaluate the efficacy of the MOVI-ageing intervention, in improving: body composition (waist circumference and fat percentage), blood pressure, and health-related quality of life.
The MOVI-ageing project has been designed in three phases comprising: i) a tool development study; ii) a 12-week randomized efficacy/feasibility trial of the intervention; and iii), a large-scale implementation phase with a 12-week randomized trial.
The investigators will use a qualitative approach to improve the plataform design with the users perspective. Participants will have access to a platform where participants will be able to view videos of cognitively demanding physical exercise programs.
The videos will be directed by an avatar and the research staff will be able to know the degree of compliance with the program and the correct execution of the program through the use of Physio Galenus technology. The platform will have information on how to be more active, and chat lines to communicate with the research group. Participants will receive feedback on their compliance with the routines and reinforcement messages.
详细描述
This study will be carried out in three phases. During the first phase, the research team will conduct a literature review and focus groups to implement in the development of the online platform the information available in the scientific evidence and the needs and expectations of the people who will use it.
The second phase will include the implementation of the platform and its piloting in a small sample of the population. This second phase will allow the researchers to improve the platform and its access based on the results and user experiences. During the third phase the platform will be made accessible to a larger population group to show its effect on improving cognitive function and cardiorespiratory fitness in the elderly
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are 60 years of age or older of both genders;
- •are retired regardless of the reason for retirement;
- •do not meet frailty criteria according to Fried criteria;
- •without disabilities for activities of daily living;
- •living independently;
- •without cognitive impairment as determined by the Mini-Mental test greater than 24 (considering the degree of schooling of the participants);
- •able to walk at least 20 meters with or without walking aids.
排除标准
- •mobility problem;
- •serious health problem (e.g., recent myocardial infarction, recent heart attack, etc.). recent myocardial infarction, uncontrolled diabetes or uncontrolled hypertension);
- •orthopedic or neurological disease that prevents training;
- •Alzheimer's disease or dementia;
- •progressive or terminal terminal illness;
- •acute or chronic illness;
- •history of heart attack;
- •history of vertigo or recent head injury;
- •health problems that may affect the ability to perform the EF programs (e.g. acute and painful joint inflammation, impaired mobility after a stroke), or any unstable health condition;
- •use of medications that act at the neuron level (e.g., psychotropic medications);
- •signs of incipient depression;
- •pathology that makes it difficult to use the computer application through which the FE program will be developed.
结局指标
主要结局
Cognitive decline
时间窗: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
Using the Minimental State Examination (MMSE) for global function
Change in cardiorespiratory fitness
时间窗: Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase
6 minutes walking test (6MWT)
次要结局
- Change in Physical function(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Weight(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Endothelial function(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in 24-hour blood pressure(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Depression, anxiety and stress(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Psychological well-being(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Height(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Body mass index (BMI)(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Health-related quality of life(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Physical activity(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in central augmentation rate (cAIx)(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Body fat percentage(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Body composition by densitometry(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Pulse wave velocity(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Fasting plasma glucose, apolipoproteins A1 and B, insulin ultrasensitive protein C and endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Comorbidities(At baseline of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in radial augmentation rate (rAIx)(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Concern about falls(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Waist circumference(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in HbA1c(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Adherence to the Mediterranean diet(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Sleep habits and quality of sleep(Baseline and at the end of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Attention(At baseline of the 12 weeks intervention in the 2nd and 3rd phase)
- Change in Working memory(At baseline of the 12 weeks intervention in the 2nd and 3rd phase)
- endothelial glycocalyx (syndecan-1, syndecan-4 and heparan sulfate proteins)(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- Change in Educational level(At baseline of the 12 weeks intervention in the 2nd phase)
- Change in Cognitive flexibility(At baseline of the 12 weeks intervention in the 2nd and 3rd phase)
- apolipoproteins A1 and B(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
- insulin ultrasensitive protein C(Baseline and at the end of the 12 weeks intervention in the 2nd phase)
研究者
CELIA ÁLVAREZ BUENO
Professor
University of Castilla-La Mancha