Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06899256
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2024-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini Mental State Examination Score', 'timeFrame': 'Baseline and Week 10', 'description': "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."}, {'measure': 'Timed Up and Go Test Performance', 'timeFrame': 'Baseline and Week 10', 'description': "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."}, {'measure': 'Rapid Mild Cognitive Impairment Test Score', 'timeFrame': 'Baseline and Week 10', 'description': 'Assessment of cognitive status using the Rapid Mild Cognitive Impairment Test. Scores will be recorded at baseline and after the 10-week intervention period.'}, {'measure': 'Warwick-Edinburgh Mental Well-Being Scale Score', 'timeFrame': 'Baseline and Week 10', 'description': '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.'}, {'measure': 'Social and Emotional Loneliness Scale for Adults Score', 'timeFrame': 'Baseline and Week 10', 'description': '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.'}, {'measure': 'World Health Organization Quality of Life Scale Elderly Module Score', 'timeFrame': 'Baseline and Week 10', 'description': "Evaluation of participants' quality of life using the WHOQOL-OLD scale. Scores will be recorded at baseline and after the 10-week intervention period."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'horticultural activity', 'nursing homes', 'quality of life'], 'conditions': ['Dementia', 'Horticultural Therapy', 'Quality of Life', 'Occupational Therapy', 'ELDERLY PEOPLE']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe assessment tools used in this study included:\n\nMini 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nResidents of a nursing home Age 65 years or older Diagnosed with dementia Mini Mental State Examination (MMSE) score of 18 or higher\n\nExclusion Criteria:\n\nOrthopedic dependency requiring the use of a wheelchair Diagnosed with any neurological or psychological disorder other than dementia'}, 'identificationModule': {'nctId': 'NCT06899256', 'briefTitle': 'The Effect of Horticultural Activities on Physical and Cognitive Status, Mental Well-Being, Social Participation and Quality of Life in Individuals Diagnosed with Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effect of Horticultural Activities on Physical and Cognitive Status, Mental Well-Being, Social Participation and Quality of Life in Individuals Diagnosed with Dementia', 'orgStudyIdInfo': {'id': '10470346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'This horticultural activity program was not implemented.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'This horticultural activity program was implemented.', 'interventionNames': ['Other: Horticultural Activity Program']}], 'interventions': [{'name': 'Horticultural Activity Program', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Merkez', 'state': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Betül Üstün'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Occupational therapist', 'investigatorFullName': 'Betul Ustün', 'investigatorAffiliation': 'Hacettepe University'}}}}