Effects of Horticultural Therapy on Elderly at Risk of Cognitive Decline
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in Clinical Dementia Rating (CDR) at baseline and at 9 months
研究概览
简要总结
The objective of this study is to determine whether horticultural therapy would improve the psychological well-being older adults who are at risk of memory (cognitive) decline. 100 elderly subjects who are at risk of cognitive decline will be randomized into the active horticultural therapy or to the waitlist control group. Sessions will be conducted weekly for 9 months, and participants will be assessed at 3 time-points: at the start of the study, at 3 months and at 9 months.
It is hypothesized that participants who undergo horticultural therapy will perform better on neuropsychological tests when compared to control, and that they will have improved psychological well-being and functional outcomes.
详细描述
Study participants comprise of community-dwelling elderly who are at risk of developing dementia, and will be selected from consenting participants from an existing community cognitive screening program.
This is an intervention study where 100 subjects will be randomized into an active horticultural therapy group, or a waitlist control group. Baseline demographic data will be collected at the start of the study. Assessments will be done at the start, at 3 months and at 6 months, which will include neuropsychological tests of cognitive functioning, psychological tests for depression and anxiety, assessment of psychosocial well-being, and tests of functional status.
The Horticultural Therapy intervention will be delivered by trained facilitators at the Therapeutic Garden at Hort Park, and consists of 1 hour sessions weekly for 9 months. The Horticultural Therapy program is designed to stimulate the senses through interaction with the tasks and the environment, promote social interaction and also to promote a sense of self-worth through completion of projects. It encompasses a range of activities including general gardening and also project-based craft activities.
The control group will be placed on a waiting list and only be contacted for assessments. They will receive intervention after the active treatment group at a later date.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-living elderly aged 60 years and above, AND
- •Mild Cognitive Impairment based on clinical history and neuropsychological test scores (Z score <0 and >-1.5), OR
- •Subjective Memory Impairment based on self-report, OR (C) 2 or more risk factors for dementia such as family history, cerebrovascular disease, and cardiovascular risk factors
排除标准
- •Existing diagnosis of dementia, OR
- •Comorbid major mental illness (such as Major Depressive Disorder and Psychosis), OR
- •Severe or unstable life-limiting medical illness, OR
- •Severe physical impairment precluding participation in Horticultural Therapy
结局指标
主要结局
Changes in Clinical Dementia Rating (CDR) at baseline and at 9 months
时间窗: Baseline, 9 months
Clinical Dementia Rating (CDR ) is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care.
Changes in Colour Trails Tests (CTT) scores at baseline, 3 months and 9 months
时间窗: Baseline, 3 months, 9 months
Colour Trails Tests (CTT) 1 and 2 assesses sustained attention and sequencing.
Changes in Digit Span Task scores at baseline, 3 months and 9 months
时间窗: Baseline, 3 months, 9 months
Digit Span Task, which consists of a Digit Span Forward (DSF) and a Digit Span Backward (DSB) task is used to assess attention and verbal working memory.
Changes in Rey Auditory Verbal Learning Test (RAVLT) scores at baseline, 3 months and 9 months
时间窗: Baseline, 3 months, 9 months
Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory.
Changes in Block Design scores at baseline, 3 months and 9 months
时间窗: Baseline, 3 months, 9 months
Block Design is a subtest that is administered as part of several of the Wechsler Intelligence tests, and it primarily measures visual-spatial and organizational processing abilities, as well as non-verbal problem-solving skills
Changes in Semantic Verbal Fluency scores at baseline, 3 months and 9 months
时间窗: Baseline, 3 months, 9 months
Semantic Verbal Fluency assess lexical knowledge and semantic memory organization.
次要结局
- Changes in Zung Self-Rating Depression Scale (SDS) scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)
- Changes in Zung Self-Rating Anxiety Scale (SAS) scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)
- Changes in Ryff's Scales of Psychological Well-being scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)
- Changes in Friendship Scale (FS) scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)
- Changes in EuroQol Five Dimensions Questionaire (ED-5D-3L) scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)
- Changes in the Modified Barthel Index (MBI) scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)
- Changes in the Instrumental Activities of Daily Living Scale (IADL) scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)
- Changes in the Pittsburgh Sleep Quality Index (PSQI) scores at baseline, 3 months and 9 months(Baseline, 3 months, 9 months)