- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06899256
The Effect of Horticultural Activities on Physical and Cognitive Status, Mental Well-Being, Social Participation and Quality of Life in Individuals Diagnosed with Dementia
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Isparta
-
Merkez, Isparta, Turkey
- Betül Üstün
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Residents of a nursing home Age 65 years or older Diagnosed with dementia Mini Mental State Examination (MMSE) score of 18 or higher
Exclusion Criteria:
Orthopedic dependency requiring the use of a wheelchair Diagnosed with any neurological or psychological disorder other than dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
This horticultural activity program was not implemented.
|
|
|
Experimental: Intervention Group
This horticultural activity program was implemented.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and Week 10
|
|
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.
|
Baseline and Week 10
|
|
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.
|
Baseline and Week 10
|
|
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.
|
Baseline and Week 10
|
|
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.
|
Baseline and Week 10
|
|
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.
|
Baseline and Week 10
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10470346
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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