Effects of a Long-term Exercise Program on Functional Ability in People With Dementia Living in Nursing Homes: a Cluster Randomised Controlled Trial. The LEDEN Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 11
- 主要终点
- Functional ability
研究概览
简要总结
This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).
详细描述
The recruitment process will be made only in NHs (Nursing Home) where the staff will have voluntarily accepted to participate in the study. We estimated to recruit 140 PWD (person with dementia) from around six-to-eight NHs (i.e., in average a minimum of 18 and a maximum of 24 PWD per NH). NHs constitute the unit of randomisation; NHs will be randomised to study groups using a 1:1 ratio (it means that all the participants living in a particular NH will participate in either the exercise training or the social activity). The randomisation will be stratified by the prevalence of dementia among NH residents; this stratification will provide homogeneity across research's arms, increasing thus the comparability among groups and producing then reliable results. Randomisation will be done by a statistician not involved in the LEDEN study. Allocation concealment will be ensured by the use opaque sealed envelopes. The randomisation list will be kept in a electronic, password-locked file matching the name of participants to their research identification number and their group allocation. Given the nature of the LEDEN intervention (exercise training, i.e., a behavioural intervention) and since the main outcome measure, i.e., participants' ability in executing ADLs, of the the study requires that the outcome assessor knows how participants cope in their daily life, LEDEN is a unblinded study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Alzheimer's disease, vascular or mixed dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
- •MMSE ≤ 20 (out of 30);
- •living in one of the participating NHs for at least 3 months at the moment of baseline measurements (this time period will allow NH staff to have a good knowledge about the patient and about recent changes in his/her health status);
- •to be able of walking at least 4 meters (with walking devices if needed but without human assistance);
- •to be able to rise from a chair without help or with minimal human assistance.
排除标准
- •Mild dementia, illustrated by a MMSE > 20 (out of 30)
- •Terminal illness with life expectancy less than 6 months;
- •Diagnosis of Parkinson's disease;
- •Diagnosis of dementia with Lewy bodies;
- •Unstable cardiovascular condition or any other health condition that might be deteriorated by physical exercise;
- •Planned transfer from the NH to another NH/home or to surgery during the 6-month period of intervention;
- •Already participating in physical exercise ≥ 2 times/week in the last 2 months prior to the date of baseline assessments.
研究组 & 干预措施
Exercise
Exercise sessions will be done in groups of three-to-eight persons; whilst being a group-based exercise program, participants will be guided and the exercises will be adapted in an individual basis, which may increase adherence and compliance rates.
干预措施: Exercise (Other)
Social activity
Participants in this group will participate in group-based activities such as music (percussion instruments), arts and board games; no intervention on physical activity will be provided to these participants.
干预措施: Social Activity (Other)
结局指标
主要结局
Functional ability
时间窗: 6th month
(ADL performance) as assessed by the Alzheimer Disease Cooperative Study (ADCS) ADL-sev. This is a 19-item scale measuring the ability to perform basic (e.g., bathing, toileting) and instrumental (e.g., turning faucet/lights on/off) ADLs in the last four weeks. The ADCS-ADL-sev was specifically validated for people with moderate or severe Alzheimer's disease (AD), i.e., the large majority of PWD in NHs. Scores in this scale vary from 0 to 54, with higher scores indicating better functional ability.
次要结局
- Pain(Baseline, Post-intervention (6 month))
- Physical function(Baseline, Post-intervention (6 month))
- Change of Functional ability(Change and evolution at different time points: baseline, 3-month intervention, Post-intervention (6month), 3-month follow-up (9 month), 6-month follow-up (12 month))
- Cognitive function(Baseline, Post-intervention (6month))
- Nutritional status(Baseline, Post-intervention (6 month))
- Cost-effectiveness of the interventions(12 month (end of study))
- Falls and fractures(12 month (end of study))
- Behavioural and psychological symptoms of dementia (BPSD)(Baseline, Post-intervention (6 month))