NCT06844084

Brief Summary

Due to the increasing number of elderly population worldwide, elderly care is becoming increasingly important and the number of elderly in institutional care is increasing. In this context, the implementation of easily applicable, cost-effective and accessible physical activity programmes for the elderly in nursing homes is important for the physical, mental and social health of the elderly. Gardening activities are a non-pharmacological intervention that has recently increased in popularity in the elderly and can be easily applied. It is known that gardening activities in the elderly affect some biochemical parameters along with mental health effects and reduce stress, especially by reducing cortisol levels. By providing physical mobility in the elderly with gardening activities, there may be an increase in irisin level and BDNF level, which is an indicator of improvement in cognitive functions, and a decrease in cortisol level, which is an indicator of stress. With the project, the effects of gardening activities on the elderly will be examined comprehensively in a biopsychosocial manner. In this project, the effects of gardening activities on anxiety, depression, life satisfaction, psychological well-being and biochemical parameters will be examined in the elderly living in a nursing home. In the project, gardening activities will be applied to the elderly in the experimental group once a week for 60 minutes for 16 weeks (4 months). With the project, it is aimed to strengthen the elderly biopsychosocially by making them do gardening activities.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

March 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 19, 2025

Last Update Submit

February 19, 2025

Conditions

Keywords

ElderlyGardening ActivityPsychological Well BeingAnxietyDepressionLife Satisfaction

Outcome Measures

Primary Outcomes (4)

  • Geriatric Anxiety Inverntory

    The scale developed by Pachana et al. (2007) was adapted to Turkish by Pamir Akın (2010). The Geriatric Anxiety Inventory aims to measure anxiety symptoms in the elderly in a dimensional manner. The cut-off point of the scale for generalized anxiety disorder was determined as 10/11. Accordingly, the scale was organized as "anxiety symptoms and generalized anxiety disorder \> 10; only anxiety symptoms \< 10". There are no reverse-coded items in the scale, which consists of 20 items and is scored on two dimensions as "agree" and "disagree". Accordingly, 1 point is given for the "agree" option and 0 points for the "disagree" option. Therefore, the scores obtained from the scale can vary between 0 and 20. Cronbach's α for the normal elderly sample was found to be 0.91, and Cronbach's α for the psychogeriatric sample was found to be 0.93.

    At the beginning of the study and end of 16 weeks treatment

  • Geriatric Depression Scale

    The scale developed by Yesavage et al. (1993) is based on self-reporting. The short form of the GDS consisting of 15 questions will be used in this study. The Turkish validity and reliability study of the scale was conducted by Ertan et al. (1997). 5 questions (1, 5, 7, 11 and 13) in the scale were designed positively, the others were designed negatively. In the evaluation of the scale, "no" answers to positive questions and "yes" answers to negative questions were matched with 1 point. The scores that can be obtained from the scale are between 0-15. A score above five is considered depression. The Cronbach alpha value of the scale is 0.92.

    At the beginning of the study and end of 16 weeks treatment

  • Life Satisfaction in the Elderly Scale

    The scale was developed by Altay and Çalmaz (2022) and consists of a total of 14 items and 3 sub-dimensions. The scale was prepared as a Likert-type, five-point scale (1= Strongly disagree, 2= Disagree, 3= Neither agree nor disagree, 4= Agree, 5= Strongly agree). The score that can be obtained from ELS varies between 14 and 70. A high score indicates that the individual has high life satisfaction. ELS contains a three-factor structure. Self-acceptance (Factor 1) of the sub-dimensions of the scale includes items 5, 6, 8, 9, 16, 21, 25, 27, 28, Motivation (Factor 2) includes items 11 and 13, and Peace (Factor 3) includes items 10, 12, and 14. Sub-dimension scores are calculated by adding the scores of the items in each sub-dimension and dividing them by the number of items. Each sub-dimension is scored between '1' and '5'. The self-acceptance sub-dimension score range is minimum - maximum 9-45, the motivation sub-dimension score range is minimum - m

    At the beginning of the study and end of 16 weeks treatment

  • Psychological Well-Being Scale for Older People

    It was developed by Gümüş Demir (2022) to measure happiness and well-being in elderly individuals, and has a 15-item and single-factor structure. Items 8 and 13 are reverse coded. The single-factor structure of the scale was tested in a different sample group with the CFA method and the result that the structure was confirmed was obtained. The scale was found to be a valid and reliable measurement tool for measuring psychological well-being in the elderly. The Cronbach alpha internal consistency coefficient of the scale was found to be 0.89.

    At the beginning of the study and end of 16 weeks treatment

Study Arms (2)

Experimental Group

EXPERIMENTAL

In the project, gardening activities will be applied to the participants in the experimental group once a week for 60 minutes for 16 weeks (4 months) in a nursing home and greenhouse. In the project, the elderly will be informed about gardening activities in the nursing home. The applications will be carried out in the greenhouse.

Other: Gardening Activity

Control Group

NO INTERVENTION

Participants in the control group will not receive any intervention during the study. They will participate in routine activities in the nursing home (crafts such as philography, relief, knitting, and folk dances and bocce games in the atelier). After the final tests are administered in the study, participants in the control group will be engaged in gardening activities for 60 minutes once a week for 4 weeks (1 month) (this period was determined by taking the project duration into account).

Interventions

In the project, gardening activities will be applied to the participants in the experimental group in the nursing home and greenhouse for 16 weeks (4 months), once a week for 60 minutes. During the implementation phase of horticulture activities, information meetings will be held in the meeting room of the nursing home in one group. In addition, 20 minutes break will be given during the activity in terms of the tolerance of the elderly to gardening activities.

Experimental Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly people who have been living in a nursing home for at least 6 months,
  • Elderly people with a mini mental test score of 24 and above,
  • Elderly people who do not have vision or hearing loss that may prevent gardening activities,
  • Elderly people who are open to communication and cooperation and who volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Elderly people with physical (such as stroke, Parkinson's) and psychiatric diseases (such as mental retardation) that may prevent gardening activities,
  • Elderly people with chronic diseases in the exacerbation process (heart failure, chronic renal failure, etc.) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepressionPersonal SatisfactionPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Central Study Contacts

Hacer Gök Uğur, Asos. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was planned as a single-blind randomized controlled experimental study. Randomized controlled experimental studies are the research design that is the source of evidence-based information on the applicability of a particular intervention, determines causality and is the basic source for systematic reviews and meta-analyses that are evaluated as first-level evidence. In this project, a randomized controlled study design was chosen to examine the biopsychosocial effects of gardening activities applied to elderly people in nursing homes and to obtain high-level evidence results. Blinding is performed to prevent bias in randomized controlled studies (Akın and Koçoğlu, 2017). In this project, participants and analyzers can be blinded to prevent bias, therefore, the study was planned to be conducted in a single-blind randomized controlled experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asos.Prof.

Study Record Dates

First Submitted

February 19, 2025

First Posted

February 25, 2025

Study Start

March 3, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share