DementiaNCT06899256
The Effect of Horticultural Activities on Physical and Cognitive Status, Mental Well-Being, Social Participation and Quality of Life in Individuals Diagnosed with Dementia
A study testing Horticultural Activity Program in people with Dementia and Horticultural Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of horticultural activities on the physical and cognitive status, mental well-being, social participation, and quality of life of individuals diagnosed with dementia living in nursing homes. Forty individuals participated in the study. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Horticultural Therapy, Quality of Life
- What is being tested?
- Horticultural Activity Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 15 Mar 2024
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Residents of a nursing home Age 65 years or older Diagnosed with dementia Mini Mental State Examination (MMSE) score of 18 or higher
Who cannot join
- Orthopedic dependency requiring the use of a wheelchair Diagnosed with any neurological or psychological disorder other than dementia
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to examine the effects of horticultural activities on the physical and cognitive status, mental well-being, social participation, and quality of life of individuals diagnosed with dementia living in nursing homes. Forty individuals participated in the study. The intervention group received a 10-week horticultural activity program, conducted two days a week (one activity day and one visit day), while the control group underwent evaluations without participating in the horticultural activities. Various standardized assessment tools were used to evaluate mental status, functional mobility, cognitive performance, mental well-being, social participation, and quality of life.
Read the detailed description
The objective of this study is to investigate the impact of a structured horticultural activity program on individuals diagnosed with dementia who reside in nursing homes. The study was conducted with a total of 40 participants. The intervention group participated in a 10-week horticultural activity program, held twice weekly, which included one activity session and one visit session per week. The control group did not participate in the activity program but underwent the same evaluation procedures.
The assessment tools used in this study included:
Mini Mental State Examination to evaluate mental status, Timed Up and Go Test to assess functional mobility, balance, and performance, Rapid Mild Cognitive Impairment Test for cognitive assessment, Warwick-Edinburgh Mental Well-Being Scale to measure mental well-being, Social and Emotional Loneliness Scale for Adults to assess social and emotional loneliness, World Health Organization Quality of Life Scale Elderly Module to evaluate quality of life.
The study is designed to explore whether horticultural activities can be beneficial as part of occupational therapy interventions for individuals with dementia living in nursing homes.
- Being tested
- Horticultural Activity Program
- Keywords
- dementia, horticultural activity, nursing homes, quality of life
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horticultural Activity ProgramOther
Prior to the commencement of the horticultural intervention program, the nursing home was visited to assess its physical environment and to inform staff about the program's objectives. Participants were recruited, and baseline data was collected. The program was structured around weekly activities and visits, with a three-day interval between each session. Activities included plant identification, gardening tasks, and nature-based art projects. The program was designed to foster social interaction, cognitive stimulation, and physical activity, while promoting a sense of accomplishment and well-being among participants. Throughout the program, regular assessments were conducted to monitor participants' progress and satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This horticultural activity program was not implemented. |
| Intervention Group | Experimental | This horticultural activity program was implemented. Receives: Other: Horticultural Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination Score
Assessment of participants' cognitive status using the Mini Mental State Examination (MMSE). Scores will be recorded at baseline and after the 10-week intervention period.
Measured: Baseline and Week 10
Timed Up and Go Test Performance
Evaluation of participants' functional mobility, balance, and performance using the Timed Up and Go Test. Results will be recorded at baseline and after the 10-week intervention period.
Measured: Baseline and Week 10
Rapid Mild Cognitive Impairment Test Score
Assessment of cognitive status using the Rapid Mild Cognitive Impairment Test. Scores will be recorded at baseline and after the 10-week intervention period.
Measured: Baseline and Week 10
Warwick-Edinburgh Mental Well-Being Scale Score
Measurement of mental well-being using the Warwick-Edinburgh Mental Well-Being Scale. Scores will be recorded at baseline and after the 10-week intervention period.
Measured: Baseline and Week 10
Social and Emotional Loneliness Scale for Adults Score
Assessment of social and emotional loneliness using the Social and Emotional Loneliness Scale for Adults. Scores will be recorded at baseline and after the 10-week intervention period.
Measured: Baseline and Week 10
World Health Organization Quality of Life Scale Elderly Module Score
Evaluation of participants' quality of life using the WHOQOL-OLD scale. Scores will be recorded at baseline and after the 10-week intervention period.
Measured: Baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start10 Apr 2023
- Primary completion25 Oct 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Ustün, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899256
- Sponsor's protocol ID
- 10470346
- Status last verified
- Mar 2025
- First submitted
- 14 Nov 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Horticultural Activities on Physical and Cognitive Status, Mental Well-Being, Social Participation and Quality of Life in Individuals Diagnosed with Dementia
- ClinicalTrials.gov ID
- NCT06899256
- Acronym / sponsor ID
- 10470346
- Keywords
- dementia, horticultural activity, nursing homes, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 27 Mar 2025 (actual)
- 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.
This study aims to examine the effects of horticultural activities on the physical and cognitive status, mental well-being, social participation, and quality of life of individuals diagnosed with dementia living in nursing homes. Forty individuals participated in the study. The intervention group received a 10-week horticultural activity program, conducted two days a week (one activity day and one visit day), while the control group underwent evaluations without participating in the horticultural activities. Various standardized assessment tools were used to evaluate mental status, functional mobility, cognitive performance, mental well-being, social participation, and quality of life.
Detailed description
The objective of this study is to investigate the impact of a structured horticultural activity program on individuals diagnosed with dementia who reside in nursing homes. The study was conducted with a total of 40 participants. The intervention group participated in a 10-week horticultural activity program, held twice weekly, which included one activity session and one visit session per week. The control group did not participate in the activity program but underwent the same evaluation procedures.
The assessment tools used in this study included:
Mini Mental State Examination to evaluate mental status, Timed Up and Go Test to assess functional mobility, balance, and performance, Rapid Mild Cognitive Impairment Test for cognitive assessment, Warwick-Edinburgh Mental Well-Being Scale to measure mental well-being, Social and Emotional Loneliness Scale for Adults to assess social and emotional loneliness, World Health Organization Quality of Life Scale Elderly Module to evaluate quality of life.
The study is designed to explore whether horticultural activities can be beneficial as part of occupational therapy interventions for individuals with dementia living in nursing homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This horticultural activity program was not implemented. |
| Intervention Group | Experimental | Other: Horticultural Activity ProgramThis horticultural activity program was implemented. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Residents of a nursing home Age 65 years or older Diagnosed with dementia Mini Mental State Examination (MMSE) score of 18 or higher
Key exclusion criteria (1 listed)
- Orthopedic dependency requiring the use of a wheelchair Diagnosed with any neurological or psychological disorder other than dementia
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 Activity ProgramPrior to the commencement of the horticultural intervention program, the nursing home was visited to assess its physical environment and to inform staff about the program's objectives. Participants were recruited, and baseline data was collected. The program was structured around weekly activities and visits, with a three-day interval between each session. Activities included plant identification, gardening tasks, and nature-based art projects. The program was designed to foster social interaction, cognitive stimulation, and physical activity, while promoting a sense of accomplishment and well-being among participants. Throughout the program, regular assessments were conducted to monitor participants' progress and satisfaction. | Other | Intervention Group |
Primary outcome
Mini Mental State Examination Score
Time frame: Baseline and Week 10
Assessment of participants' cognitive status using the Mini Mental State Examination (MMSE). Scores will be recorded at baseline and after the 10-week intervention period.
Timed Up and Go Test Performance
Time frame: Baseline and Week 10
Evaluation of participants' functional mobility, balance, and performance using the Timed Up and Go Test. Results will be recorded at baseline and after the 10-week intervention period.
Rapid Mild Cognitive Impairment Test Score
Time frame: Baseline and Week 10
Assessment of cognitive status using the Rapid Mild Cognitive Impairment Test. Scores will be recorded at baseline and after the 10-week intervention period.
Warwick-Edinburgh Mental Well-Being Scale Score
Time frame: Baseline and Week 10
Measurement of mental well-being using the Warwick-Edinburgh Mental Well-Being Scale. Scores will be recorded at baseline and after the 10-week intervention period.
Social and Emotional Loneliness Scale for Adults Score
Time frame: Baseline and Week 10
Assessment of social and emotional loneliness using the Social and Emotional Loneliness Scale for Adults. Scores will be recorded at baseline and after the 10-week intervention period.
World Health Organization Quality of Life Scale Elderly Module Score
Time frame: Baseline and Week 10
Evaluation of participants' quality of life using the WHOQOL-OLD scale. Scores will be recorded at baseline and after the 10-week intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Activity Program in people with Dementia and Horticultural Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mini Mental State Examination Score (time frame: Baseline and Week 10). 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?
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 27 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.