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Clinical Trials/NCT03045718
NCT03045718UnknownNot Applicable

Effects of Horticultural Therapy on Elderly at Risk of Cognitive Decline

National University Hospital, Singapore1 site in 1 country100 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Changes in Block Design scores at baseline, 3 months and 9 months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Horticultural Therapy

Experimental

Horticultural Therapy will consists of 1 hour sessions, weekly for 9 months, to engage subjects in gardening-based activities.

Intervention: Horticultural Therapy (Behavioral)

Waitlist Control

Other

The control group will be placed on a waiting list and only be contacted for assessments. They will receive the same Horticultural Therapy intervention after the active treatment group at a later date.

Intervention: Horticultural Therapy (Behavioral)

Outcomes

Primary Outcomes

Changes in Block Design scores at baseline, 3 months and 9 months

Time Frame: 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

Time Frame: Baseline, 3 months, 9 months

Semantic Verbal Fluency assess lexical knowledge and semantic memory organization.

Changes in Clinical Dementia Rating (CDR) at baseline and at 9 months

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Baseline, 3 months, 9 months

Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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