Clinical trial NCT03045718: Effects of Horticultural Therapy on Elderly at Risk of Cognitive Decline
Official title: Effects of Horticultural Therapy on Elderly at Risk of Cognitive Decline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Horticultural Therapy
Dementia
Keywords: Horticultural Therapy
Dementia
Randomized Controlled Trial
Elderly
Prevention
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Parks Board, Singapore
name: Ministry of Health, Singapore
name: Ministry of National Development, Singapore
First posted: 2017-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Community-living elderly aged 60 years and above, AND 2.

1. Mild Cognitive Impairment based on clinical history and neuropsychological test scores (Z score \<0 and \>-1.5), OR
2. 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

Exclusion Criteria:

1. Existing diagnosis of dementia, OR
2. Comorbid major mental illness (such as Major Depressive Disorder and Psychosis), OR
3. Severe or unstable life-limiting medical illness, OR
4. Severe physical impairment precluding participation in Horticultural Therapy

Primary outcomes:
measure: Changes in Clinical Dementia Rating (CDR) at baseline and at 9 months
timeFrame: Baseline, 9 months
measure: Changes in Colour Trails Tests (CTT) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in Digit Span Task scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in Rey Auditory Verbal Learning Test (RAVLT) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in Block Design scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in Semantic Verbal Fluency scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
Secondary outcomes:
measure: Changes in Zung Self-Rating Depression Scale (SDS) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in Zung Self-Rating Anxiety Scale (SAS) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in Ryff's Scales of Psychological Well-being scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in Friendship Scale (FS) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in EuroQol Five Dimensions Questionaire (ED-5D-3L) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in the Modified Barthel Index (MBI) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in the Instrumental Activities of Daily Living Scale (IADL) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
measure: Changes in the Pittsburgh Sleep Quality Index (PSQI) scores at baseline, 3 months and 9 months
timeFrame: Baseline, 3 months, 9 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Associate Consultant
name: Hong Yee Tan, MMed(Psy)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soga M, Gaston KJ, Yamaura Y. Gardening is beneficial for health: A meta-analysis. Prev Med Rep. 2016 Nov 14;5:92-99. doi: 10.1016/j.pmedr.2016.11.007. eCollection 2017 Mar.
citation: Blake M, Mitchell G. Horticultural therapy in dementia care: a literature review. Nurs Stand. 2016 Jan 20;30(21):41-7. doi: 10.7748/ns.30.21.41.s44.
citation: Noone S, Innes A, Kelly F, Mayers A. 'The nourishing soil of the soul': The role of horticultural therapy in promoting well-being in community-dwelling people with dementia. Dementia (London). 2017 Oct;16(7):897-910. doi: 10.1177/1471301215623889. Epub 2015 Dec 23.
citation: Kamioka H, Tsutani K, Yamada M, Park H, Okuizumi H, Honda T, Okada S, Park SJ, Kitayuguchi J, Abe T, Handa S, Mutoh Y. Effectiveness of horticultural therapy: a systematic review of randomized controlled trials. Complement Ther Med. 2014 Oct;22(5):930-43. doi: 10.1016/j.ctim.2014.08.009. Epub 2014 Sep 1.
citation: Annerstedt M, Wahrborg P. Nature-assisted therapy: systematic review of controlled and observational studies. Scand J Public Health. 2011 Jun;39(4):371-88. doi: 10.1177/1403494810396400. Epub 2011 Jan 27.