NCT02462291

Brief Summary

Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of disability with elevated social costs. Alternative solutions to the standard pharmacological therapies have been studied in order to reduce the use of medications that frequently generates side effects and worsen patients' quality of life. A recent alternative treatment for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this approach is still mater of debate. Therefore, the aim of this trial will be to analyze the effects of EET, in people with severe AD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 29, 2016

Completed
Last Updated

October 12, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

May 28, 2015

Results QC Date

December 1, 2015

Last Update Submit

September 14, 2018

Conditions

Alzheimer DiseaseBehavioral DisordersCognitive Impairment

Keywords

Neurological DisordersNon Pharmacological TreatmentEcological Therapy

Outcome Measures

Primary Outcomes (2)

  • Evaluations of Behavioral Disorders

    Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome.

    PRE and POST 6 months of treatment

  • Evaluation of Cognitive Status (Score 0-30)

    Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome.

    PRE and POST 6 months of treatment

Secondary Outcomes (15)

  • Body Composition (Kilograms of Fat Free Mass)

    PRE and POST 6 months of treatment

  • Systolic Blood Pressure (mmHg)

    PRE and POST 6 months of treatment

  • Diastolic Blood Pressure (mmHg)

    PRE and POST 6 months of treatment

  • Blood Glucose (mg/dl)

    PRE and POST 6 months of treatment

  • Blood Cholesterol HDL (mg/dl)

    PRE and POST 6 months of treatment

  • +10 more secondary outcomes

Study Arms (2)

Experimental group (TR)

EXPERIMENTAL

A group of 80 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months.

Other: Ecological Environmental therapy

Control group (CTRL)

NO INTERVENTION

A group of 80 patients with AD will be treated with the standard therapy.

Interventions

Ecological Environmental therapyOTHER

The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD.

Experimental group (TR)

Eligibility Criteria

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

You may qualify if:

  • Person with Alzheimer's disease.

You may not qualify if:

  • Bedridden patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mons. Mazzali Foundation

Mantua Italy, Mantua, 46100, Italy

Location

Related Publications (15)

  • Calkins MP. Evidence-based long term care design. NeuroRehabilitation. 2009;25(3):145-54. doi: 10.3233/NRE-2009-0512.

    PMID: 19893184BACKGROUND

  • Friedrich MJ. Therapeutic environmental design aims to help patients with Alzheimer disease. JAMA. 2009 Jun 17;301(23):2430. doi: 10.1001/jama.2009.809. No abstract available.

    PMID: 19531775BACKGROUND

  • Detweiler MB, Sharma T, Detweiler JG, Murphy PF, Lane S, Carman J, Chudhary AS, Halling MH, Kim KY. What is the evidence to support the use of therapeutic gardens for the elderly? Psychiatry Investig. 2012 Jun;9(2):100-10. doi: 10.4306/pi.2012.9.2.100. Epub 2012 May 22.

    PMID: 22707959BACKGROUND

  • Detweiler MB, Murphy PF, Myers LC, Kim KY. Does a wander garden influence inappropriate behaviors in dementia residents? Am J Alzheimers Dis Other Demen. 2008 Feb-Mar;23(1):31-45. doi: 10.1177/1533317507309799.

    PMID: 18276956BACKGROUND

  • Smith R, Mathews RM, Gresham M. Pre- and postoccupancy evaluation of new dementia care cottages. Am J Alzheimers Dis Other Demen. 2010 May;25(3):265-75. doi: 10.1177/1533317509357735. Epub 2010 Feb 11.

    PMID: 20150654BACKGROUND

  • Detweiler MB, Murphy PF, Kim KY, Myers LC, Ashai A. Scheduled medications and falls in dementia patients utilizing a wander garden. Am J Alzheimers Dis Other Demen. 2009 Aug-Sep;24(4):322-32. doi: 10.1177/1533317509334036. Epub 2009 Apr 14.

    PMID: 19366885BACKGROUND

  • Heath Y. Evaluating the effect of therapeutic gardens. Am J Alzheimers Dis Other Demen. 2004 Jul-Aug;19(4):239-42. doi: 10.1177/153331750401900410.

    PMID: 15359562BACKGROUND

  • Rodenburg M. Special facilities for patients with Alzheimer's disease. CMAJ. 1986 Feb 15;134(4):315-6. No abstract available.

    PMID: 3942940BACKGROUND

  • Rivasseau Jonveaux T, Batt M, Fescharek R, Benetos A, Trognon A, Bah Chuzeville S, Pop A, Jacob C, Yzoard M, Demarche L, Soulon L, Malerba G, Bouvel B. Healing gardens and cognitive behavioral units in the management of Alzheimer's disease patients: the Nancy experience. J Alzheimers Dis. 2013;34(1):325-38. doi: 10.3233/JAD-121657.

    PMID: 23207487BACKGROUND

  • Gonzalez MT, Kirkevold M. Benefits of sensory garden and horticultural activities in dementia care: a modified scoping review. J Clin Nurs. 2014 Oct;23(19-20):2698-715. doi: 10.1111/jocn.12388. Epub 2013 Oct 15.

    PMID: 24128125BACKGROUND

  • York SL. Residential design and outdoor area accessibility. NeuroRehabilitation. 2009;25(3):201-8. doi: 10.3233/NRE-2009-0516.

    PMID: 19893188BACKGROUND

  • Venturelli M, Scarsini R, Muti E, Salvagno GL, Schena F. Sundowning syndrome and hypothalamic-pituitary-adrenal axis dysregulation in individuals with Alzheimer's disease: is there an association? J Am Geriatr Soc. 2013 Nov;61(11):2055-6. doi: 10.1111/jgs.12491. No abstract available.

    PMID: 24219216BACKGROUND

  • Venturelli M, Magalini A, Scarsini R, Schena F. From Alzheimer's disease retrogenesis: a new care strategy for patients with advanced dementia. Am J Alzheimers Dis Other Demen. 2012 Nov;27(7):483-9. doi: 10.1177/1533317512459794. Epub 2012 Sep 13.

    PMID: 22984089BACKGROUND

  • Venturelli M, Scarsini R, Schena F. Six-month walking program changes cognitive and ADL performance in patients with Alzheimer. Am J Alzheimers Dis Other Demen. 2011 Aug;26(5):381-8. doi: 10.1177/1533317511418956. Epub 2011 Aug 17.

    PMID: 21852281BACKGROUND

  • Venturelli M, Lanza M, Muti E, Schena F. Positive effects of physical training in activity of daily living-dependent older adults. Exp Aging Res. 2010 Apr;36(2):190-205. doi: 10.1080/03610731003613771.

    PMID: 20209421BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseMental DisordersCognitive DysfunctionNervous System Diseases

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersCognition Disorders

Results Point of Contact

Title
Massimo Venturelli - PI
Organization
University of Verona
massimo.venturelli@univr.it
+39 02503 14648

Study Officials

  • Massimo Venturelli, Ph.D.

    Universita di Verona

    PRINCIPAL INVESTIGATOR

  • Federico Schena, MD; Ph.D.

    Universita di Verona

    STUDY DIRECTOR

  • Nicola Smania, MD

    Universita di Verona

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 4, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

October 12, 2018

Results First Posted

February 29, 2016

Record last verified: 2018-09

Locations

IT(1)