Horticultural TherapyNCT03045718
Effects of Horticultural Therapy on Elderly at Risk of Cognitive Decline
A study testing Horticultural Therapy in people with Horticultural Therapy and Dementia, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Horticultural Therapy, Dementia
- What is being tested?
- Horticultural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Community-living elderly aged 60 years and above, AND 2.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Horticultural Therapy, Dementia
- Being tested
- Horticultural Therapy
- Keywords
- Horticultural Therapy, Dementia, Randomized Controlled Trial, Elderly, Prevention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horticultural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Horticultural Therapy | Experimental | Horticultural Therapy will consists of 1 hour sessions, weekly for 9 months, to engage subjects in gardening-based activities. Receives: Behavioral: Horticultural Therapy |
| 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. Receives: Behavioral: Horticultural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Clinical Dementia Rating (CDR) at baseline and at 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.
Measured: Baseline, 9 months
Changes in Colour Trails Tests (CTT) scores at baseline, 3 months and 9 months
Colour Trails Tests (CTT) 1 and 2 assesses sustained attention and sequencing.
Measured: Baseline, 3 months, 9 months
Changes in Digit Span Task scores at baseline, 3 months and 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.
Measured: Baseline, 3 months, 9 months
Changes in Rey Auditory Verbal Learning Test (RAVLT) scores at baseline, 3 months and 9 months
Rey Auditory Verbal Learning Test (RAVLT) evaluates declarative verbal learning and memory.
Measured: Baseline, 3 months, 9 months
Changes in Block Design scores at baseline, 3 months and 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
Measured: Baseline, 3 months, 9 months
Changes in Semantic Verbal Fluency scores at baseline, 3 months and 9 months
Semantic Verbal Fluency assess lexical knowledge and semantic memory organization.
Measured: Baseline, 3 months, 9 months
Secondary outcomes (8)
Changes in Zung Self-Rating Depression Scale (SDS) scores at baseline, 3 months and 9 months
The SDS (Zung, 1965) is a 20-item quantitative measurement of symptoms of depression. Participants rate each item regarding how they felt during the week preceding using a 4-point scale that ranges from 1 (a little of the time) to 4 (most of the time). A total raw score computed by summing the scores on the individual items will be converted into a percentage (the SDS index); the higher the SDS index, the greater the severity of depressive symptoms. Several studies have established the SDS as a reliable and valid instrument for measuring depressive symptoms (Biggs et al., 1978; Gabrys and Peters, 1985; Agrell and Dehlin, 1989).
Measured: Baseline, 3 months, 9 months
Changes in Zung Self-Rating Anxiety Scale (SAS) scores at baseline, 3 months and 9 months
The SAS (Zung, 1971) will be used to measure anxiety of the participants in the preceding week. It is a 20-item self-report assessment designed to measure anxiety levels, based on cognitive, autonomic, motor and central nervous system symptoms. Each question is scored on a Likert-type scale of 1-4 (a little of the time) to (most of the time). Some questions are negatively worded to avoid the problem of set response. Overall assessment is done by total score. The total raw scores range from 20-80. The raw score then needs to be converted to an "Anxiety Index" score; the higher the SAS index, the greater the severity of depressive symptoms.
Measured: Baseline, 3 months, 9 months
Changes in Ryff's Scales of Psychological Well-being scores at baseline, 3 months and 9 months
The Ryff Scales of Psychological Well-Being (Ryff and Singer, 1998) is an 18-item questionnaire which reflects the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.
Measured: Baseline, 3 months, 9 months
Changes in Friendship Scale (FS) scores at baseline, 3 months and 9 months
Social connectedness scale will be measured using the Friendship Scale (Hawthorne, 2006). It is a 6-item questionnaire that measures both social isolation and social connectedness. Participants were asked to rate the frequency in which each statement describes them during the past four weeks on a 5-point Likert scale ranging from 0 (almost always) to 5 (not at all). Total scores were computed by summing the scores on the individual items and ranged from 0 to 24, with higher scores indicating higher level of social connectedness. The Friendship Scale was developed as a short, user-friendly, stand alone scale measuring perceived social isolation. It was validated with older adults with excellent internal structures, reliability and validity (Hawthorne, 2006; Hawthorne, 2008).
Measured: Baseline, 3 months, 9 months
Changes in EuroQol Five Dimensions Questionaire (ED-5D-3L) scores at baseline, 3 months and 9 months
The E5-5D-3L is a standardized instrument for measuring general health status, which consists of 5 questions and a visual analog scale - which is a self-rating scale ranging from zero (0) to one hundred (100) to indicate the perceived health state from worst to best respectively.
Measured: Baseline, 3 months, 9 months
Changes in the Modified Barthel Index (MBI) scores at baseline, 3 months and 9 months
The MBI is an instrument used to assess the performance in Activities of Daily Living, and consists of 10 variables that reflect activities of daily living and mobility used to monitor functional status.
Measured: Baseline, 3 months, 9 months
Changes in the Instrumental Activities of Daily Living Scale (IADL) scores at baseline, 3 months and 9 months
The IADL Scale is used to assess more complex activities of daily living necessary for functioning in community living, such as handling finances and food preparation. It consists of 8 items which are summarily scored from zero (low functioning) to 8 (high functioning)
Measured: Baseline, 3 months, 9 months
Changes in the Pittsburgh Sleep Quality Index (PSQI) scores at baseline, 3 months and 9 months
The PSQI is a self-report questionnaire that assesses sleep quality, and consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
Measured: Baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Horticultural TherapyStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Parks Board, Singapore, Ministry of Health, Singapore, Ministry of National Development, Singapore
- Responsible party
- Sponsor
- Investigators
- Hong Yee Tan, MMed(Psy), Principal investigator, Associate Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045718
- Sponsor's protocol ID
- 2016/00949
- Other IDs
- 2016
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared, in the interests of subject confidentiality
Publications
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.
PubMed 27981022Blake 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.
PubMed 26786461Noone 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.
PubMed 26701960Kamioka 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.
PubMed 25440385Annerstedt 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.
PubMed 21273226
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Horticultural Therapy on Elderly at Risk of Cognitive Decline
- ClinicalTrials.gov ID
- NCT03045718
- Acronym / sponsor ID
- 2016/00949
- Conditions
- Horticultural Therapy, Dementia
- Keywords
- Horticultural Therapy, Dementia, Randomized Controlled Trial, Elderly, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Parks Board, Singapore, Ministry of Health, Singapore, Ministry of National Development, Singapore
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horticultural Therapy | Experimental | Behavioral: Horticultural TherapyHorticultural Therapy will consists of 1 hour sessions, weekly for 9 months, to engage subjects in gardening-based activities. |
| Waitlist Control | Other | Behavioral: Horticultural TherapyThe 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Community-living elderly aged 60 years and above, AND 2.
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horticultural TherapyThe 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. | Behavioural | Horticultural Therapy, Waitlist Control |
Primary outcome
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.
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.
8 secondary outcomes
Changes in Zung Self-Rating Depression Scale (SDS) scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Changes in Zung Self-Rating Anxiety Scale (SAS) scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Changes in Ryff's Scales of Psychological Well-being scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Changes in Friendship Scale (FS) scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Changes in EuroQol Five Dimensions Questionaire (ED-5D-3L) scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Changes in the Modified Barthel Index (MBI) scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Changes in the Instrumental Activities of Daily Living Scale (IADL) scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Changes in the Pittsburgh Sleep Quality Index (PSQI) scores at baseline, 3 months and 9 months
Time frame: Baseline, 3 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 27981022Soga 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.
- Background: PubMed 26786461Blake 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.
- Background: PubMed 26701960Noone 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.
- Background: PubMed 25440385Kamioka 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.
- Background: PubMed 21273226Annerstedt 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.
- Individual participant dataSharing planned: No. Individual data will not be shared, in the interests of subject confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Yee Tan, MMed(Psy) principal investigator
Associate Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horticultural Therapy in people with Horticultural Therapy and Dementia, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Clinical Dementia Rating (CDR) at baseline and at 9 months (time frame: Baseline, 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045718, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.