LiFE4D: a Home-based Physical Activity Program for Community-dwelling People With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 2 Minute Step test - change in exercise tolerance
研究概览
简要总结
Physical activity improves cognitive function and the ability to perform activities of daily living in people with dementia and reduces caregivers' burden thus, enhancing quality of life of people with dementia and their caregivers. The wish of most people with dementia, and their caregivers, is to live at their home, for as long as possible. However community-dwelling people with dementia have low levels of physical activity, increasing dependency, which often leads to institutionalization. The Lifestyle Integrated Functional Exercise (LiFE) program has been shown to decrease sedentary activity time and dependency in activities of daily living of older people, however, it has never been implemented in people with dementia. LiFE might be promising as it focuses on establishing new behaviors within selected contexts to stimulate physical activity at home. Therefore, a home-based physical activity program, based on LiFE and involving caregivers, LiFE4D, will be implemented and evaluated in community-dwelling people with dementia.
详细描述
Sustaining levels of regular physical activity of people with dementia is essential to maintain independence on activities of daily living, increase health-related quality of life and delay the need for institutionalization. Home-based physical activity programs, involving the caregivers, may overcome the drawbacks of the low adherence and high dropout rates by including physical activity in daily routines of people with dementia, thus increasing their motivation and confidence levels. LiFE is a home-based physical activity program which embeds training into patients' daily routines. It has shown to be well accepted and effective in healthy older people, however its effectiveness in people with dementia remains unknown.
Therefore, the primary aim of this study is to assess the impact of a home-based physical activity program, based on the LiFE program and involving the caregivers (LiFE4D), on exercise tolerance of community-dwelling people with dementia, using a randomized controlled design. The secondary aims are to:
- establish the feasibility of LiFE4D and adherence to the intervention;
- explore the impact of the LiFE4D on other health-related physical fitness components, (i.e., neuromotor, muscular strength, flexibility and body composition); physical activity, health-related quality of life, social networks and informal care time provision;
- assess the cost-effectiveness of the LiFE4D on the number of falls, healthcare resources utilization, length of hospital stay and number of respiratory infections.
To accomplish these aims, a pilot (task 1) and a randomized controlled study (task 2) will be conducted. LiFE4D will be centered on the duo participant/caregiver capacities and potentialities and it will be a significant contribution towards the development and implementation of an innovative home-based physical activity intervention. Additionally, it will inform the cost-effectiveness of this intervention in people with dementia. Ultimately, findings from this project will provide guidance to national and international health policies on physical activity promotion in community-dwelling people with dementia.
Task 1: LiFE4D - Pilot study
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a diagnosis of mild/moderate dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V); are living at home; are not participating in exercise training; are able to follow instructions and have a caregiver.
排除标准
- •have been hospitalized in the previous month; present any clinical condition that precludes them to be involved in physical activity; have been taking medication that affect exercise capacity/bone density.
研究组 & 干预措施
Experimental group
The experimental group will receive the LiFE4D in addition to usual care (e.g., pharmacologic treatment).
干预措施: Experimental group (Other)
Control group
The control group will receive usual care only.
结局指标
主要结局
2 Minute Step test - change in exercise tolerance
时间窗: Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.
Participants' exercise tolerance will be assessed with the 2 Minute Step Test, counting the number of times the right knee is raised to the level of the mark on the wall or board (half way between the participant's knee and iliac crest). Higher number of repetitions indicate better performance.
次要结局
- Grocery Shelving Task - change in upper limb functionality(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Chair sit and reach test - change in flexibility(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Timed Up and Go test - change in functional mobility(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Accelerometer-based activity monitors - change in physical activity levels(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Maximal inspiratory (MIP) and expiratory (MEP) pressures and Sniff Nasal Inspiratory Pressure (SNIP) - change in respiratory muscle strength(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Short Form Zarit Burden Interview - change in caregivers' burden(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Brief Physical Activity Assessment tool - change in self-reported physical activity(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Handgrip Dynamometer - change in maximum isometric strength of the hand and forearm muscles(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Functional Reach Test - change in functionality(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- 30 second sit to stand test - change in lower limb strength(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Resource Utilization in Dementia - Lite - change in informal time provision(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Addenbrooke's Cognitive Examination III - change in cognitive function(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Brief Balance Evaluation System Test - change in balance(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Physical Performance Test - change in overall functionality(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Peak Flow Meter - change in lung function(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
- Quality of Life in Alzheimer's Disease scale - change in health-related quality of life(Assessment at baseline, post (3 months) and 3 months and 6 months follow-up for experimental and control groups.)
研究者
Alda Sofia Pires de Dias Marques
Senior lecturer, Dr.
Aveiro University