Horticultural TherapyHortitherapyNCT05381259
Effectiveness of Hortitherapy on the Immediate Well-being of Elderly People With Alzheimer's Disease or Related in Day Care
A study testing hortitherapy in people living with Alzheimer's taking place in three different day care in people with Horticultural Therapy, run by Centre Médical Porte Verte at 1 site in France.
Trial summary
Currently, there are an estimated 47 million people with dementia worldwide, with approximately 10 million new cases diagnosed each year. This figure is expected to triple to 130 million in 2050. In France, the number of dementia cases is estimated at 754,000 and could reach 1,813,000 in 2050. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Horticultural Therapy
- What is being tested?
- hortitherapy in people living with Alzheimer's taking place in three different day care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2022to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient having signed an informed and written consent,
- Patient aged over 60,
- Patient with Alzheimer's or related disease,
- Patient benefiting from day care,
- Patient under guardianship or curatorship.
Who cannot join
- Patient in period of adaptation in day care,
- Patient in temporary care at day care,
- Patient having participated in less than 4 horticultural workshops during the cycle,
- Patient with severe asthma and/or an allergy that does not allow workshops to be carried out,
- Patient with major behavioral problems that make it impossible to carry out the workshops.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CentreMédicalPorteVerte
Versailles, 78000
Adèle de Malherbe, Dr, 0033139637444, ademalherbe@hopitalporteverte.com
Dr
About this study
Currently, there are an estimated 47 million people with dementia worldwide, with approximately 10 million new cases diagnosed each year. This figure is expected to triple to 130 million in 2050.
In France, the number of dementia cases is estimated at 754,000 and could reach 1,813,000 in 2050.
Read more
In a recent literature review, researchers highlighted the many benefits of horticultural therapy and garden environments for people with Alzheimer's or cognitive disorders. They include: alleviating pain, improving attention, decreasing stress, relieving agitation, decreasing the use of medications, such as antipsychotics, as well as reducing falls.
Gardening offers a non-pharmacological approach to achieving these goals and could improve the quality of life for people with Alzheimer's disease or another dementia. As part of a care solution, support services that include social activities, such as gardening, reduce the need for more intrusive and expensive care solutions.
The objective of this research is to evaluate the impact of horticultural
Read the detailed description
This research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is prospective, multicenter and non-randomized.
The study will take place with users of the Lépine Versailles day care centre, the La Porte Verte hospital and the Les Magnolias Geriatric Center, living with cognitive disorders. For the purposes of this study, understanding the instructions is required.
The people welcomed will participate in their usual day supervised by the day reception team.
Part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered. The study will be done with 52 users with the participation of a supervisor to animate the workshops of the different groups.
Each site will have a workshop that will take place in the morning from 11 a.m. to 12 p.m. and one in the afternoon from 2:30 p.m. to 3:30 p.m. This will make it possible to compare the well-being of users according to the time of the workshop.
- Conditions
- Horticultural Therapy
- Being tested
- hortitherapy in people living with Alzheimer's taking place in three different day care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hortitherapy in people living with Alzheimer's taking place in three different day careBehavioural
6 users benefiting from the horticultural workshop and 6 others from a usual workshop (control group) This control group will benefit from its usual workshop while the other group will participate in the horticultural workshop.
If it is impossible to carry out the workshops outdoors (rain or high heat), the day reception centers will provide a room to allow the workshops to be carried out. They will be adapted in terms of activities and materials.
| Study group | Role | What they receive |
|---|---|---|
| hortitherapy intervention versus control | Other | Horticultural therapy refers to physical and psychic therapy by nature by focusing on the action of gardening on the body, intellect, psych and mind.
Horticultural in the form of therapeutic gardening serves as a support to help and treat various pathologies in the brain.
It is a form of curative treatment exploiting the planting and maintenance of garden. The term is a contraction of " horticultural " and " therapy". Receives: Behavioral: hortitherapy in people living with Alzheimer's taking place in three different day care |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVIBE : An instant assessment scale of perceived well-being in people with major cognitive problems.
The score of the EVIBE scale is a numerical score between 0 and 5, it will be compared between the two groups, the patients will be integrated randomly in order to take into account the correlation between the data due to the repeated nature of the measurements.
The regression application conditions will be checked graphically on the residuals. If they are not respected, alternative strategies will be studied (log transformation, bootstrap test)
Measured: Eight months
Secondary outcomes (2)
Tinetti test : Assessment of walking and balance (Tinetti 1986).
The Tinetti test is an effective and reproducible tool for the assessment of the risk of falling, its administration time is approximately 5 to 10 minutes and evaluates static and dynamic balance.
Measured: Eight months
HAD Scale : Hospital Anxiety and Depression
The advantage of this scale is to quickly and simultaneously assess depressive and anxious dimensions using a short questionnaire. The scale is collected on inclusion and after the 8 weeks of treatment.
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start4 May 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horticultural TherapyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Médical Porte Verte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adèle de Malherbe, Centre Médical Porte Verte
- Investigators
- Adèle DE MALHERBE, Dr, Study director, Director of the Medico-Social DepartementBenjamin BAUBERT, Principal investigator, CENTRE 2 EHPAD Lépine Versaillesophelie LEMBRET, Principal investigator, CENTRE 3 HPGM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381259
- Sponsor's protocol ID
- 2022-A00357-36
- Acronym
- Hortitherapy
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hortitherapy on the Immediate Well-being of Elderly People With Alzheimer's Disease or Related in Day Care
- ClinicalTrials.gov ID
- NCT05381259
- Acronym / sponsor ID
- Hortitherapy / 2022-A00357-36
- Conditions
- Horticultural Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Centre Médical Porte VerteUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 May 2022 (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.
Currently, there are an estimated 47 million people with dementia worldwide, with approximately 10 million new cases diagnosed each year. This figure is expected to triple to 130 million in 2050.
In France, the number of dementia cases is estimated at 754,000 and could reach 1,813,000 in 2050.
In a recent literature review, researchers highlighted the many benefits of horticultural therapy and garden environments for people with Alzheimer's or cognitive disorders. They include: alleviating pain, improving attention, decreasing stress, relieving agitation, decreasing the use of medications, such as antipsychotics, as well as reducing falls.
Gardening offers a non-pharmacological approach to achieving these goals and could improve the quality of life for people with Alzheimer's disease or another dementia. As part of a care solution, support services that include social activities, such as gardening, reduce the need for more intrusive and expensive care solutions.
The objective of this research is to evaluate the impact of horticultural
Detailed description
This research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is prospective, multicenter and non-randomized.
The study will take place with users of the Lépine Versailles day care centre, the La Porte Verte hospital and the Les Magnolias Geriatric Center, living with cognitive disorders. For the purposes of this study, understanding the instructions is required.
The people welcomed will participate in their usual day supervised by the day reception team.
Part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered. The study will be done with 52 users with the participation of a supervisor to animate the workshops of the different groups.
Each site will have a workshop that will take place in the morning from 11 a.m. to 12 p.m. and one in the afternoon from 2:30 p.m. to 3:30 p.m. This will make it possible to compare the well-being of users according to the time of the workshop.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered.
| Arm | Type | Receives |
|---|---|---|
| hortitherapy intervention versus control | Other | Behavioral: hortitherapy in people living with Alzheimer's taking place in three different day careHorticultural therapy refers to physical and psychic therapy by nature by focusing on the action of gardening on the body, intellect, psych and mind. Horticultural in the form of therapeutic gardening serves as a support to help and treat various pathologies in the brain. It is a form of curative treatment exploiting the planting and maintenance of garden. The term is a contraction of " horticultural " and " therapy". |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient having signed an informed and written consent,
- Patient aged over 60,
- Patient with Alzheimer's or related disease,
- Patient benefiting from day care,
- Patient under guardianship or curatorship.
Key exclusion criteria (5 listed)
- Patient in period of adaptation in day care,
- Patient in temporary care at day care,
- Patient having participated in less than 4 horticultural workshops during the cycle,
- Patient with severe asthma and/or an allergy that does not allow workshops to be carried out,
- Patient with major behavioral problems that make it impossible to carry out the workshops.
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 |
|---|---|---|
| hortitherapy in people living with Alzheimer's taking place in three different day care6 users benefiting from the horticultural workshop and 6 others from a usual workshop (control group) This control group will benefit from its usual workshop while the other group will participate in the horticultural workshop. If it is impossible to carry out the workshops outdoors (rain or high heat), the day reception centers will provide a room to allow the workshops to be carried out. They will be adapted in terms of activities and materials. | Behavioural | hortitherapy intervention versus control |
Primary outcome
EVIBE : An instant assessment scale of perceived well-being in people with major cognitive problems.
Time frame: Eight months
The score of the EVIBE scale is a numerical score between 0 and 5, it will be compared between the two groups, the patients will be integrated randomly in order to take into account the correlation between the data due to the repeated nature of the measurements. The regression application conditions will be checked graphically on the residuals. If they are not respected, alternative strategies will be studied (log transformation, bootstrap test)
2 secondary outcomes
Tinetti test : Assessment of walking and balance (Tinetti 1986).
Time frame: Eight months
HAD Scale : Hospital Anxiety and Depression
Time frame: Eight months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Gardening for Health for Cancer Survivors
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A Study on the Intervention Effect of Therapeutic Horticulture Based on the Healing System on Non-suicidal Self-injury in Adolescent Patients With Depression
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Healthy
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.
Adèle DE MALHERBE, Dr study director
Director of the Medico-Social Departement
Benjamin BAUBERT principal investigator
CENTRE 2 EHPAD Lépine Versailles
ophelie LEMBRET principal investigator
CENTRE 3 HPGM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hortitherapy in people living with Alzheimer's taking place in three different day care in people with Horticultural Therapy, run by Centre Médical Porte Verte at 1 site in France.
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 5 inclusion and 5 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 10 Jan 2023. 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 France. 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?
Contact Marine ZAIBAT (+33039637491, mzaibat@hopitalporteverte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVIBE : An instant assessment scale of perceived well-being in people with major cognitive problems. (time frame: Eight months). 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 10 Jan 2023.