Overview

This trial is active, not recruiting.

Conditions alzheimer disease, behavioral disorders, cognitive impairment
Treatment ecological environmental therapy
Sponsor Universita di Verona
Collaborator Mons. Mazzali Foundation (Mantua, Italy)
Start date June 2015
End date October 2015
Trial size 160 participants
Trial identifier NCT02462291, 18201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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.
ecological environmental therapy
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.
(No Intervention)
A group of 80 patients with AD will be treated with the standard therapy.

Primary Outcomes

Measure
Evaluations of behavioral disorders (Score 0-144)
time frame: 6 months
Evaluation of cognitive status (Score 0-30)
time frame: 6 months

Secondary Outcomes

Measure
Body composition (% of body fat)
time frame: 6 months
Blood pressure (mmHg)
time frame: 6 months
Salivary cortisol (nmol/l)
time frame: 6 months
Blood glucose (mg/dl)
time frame: 6 months
Blood cholesterol (mg/dl)
time frame: 6 months
Daily energy expenditure (Kcal/day)
time frame: 2 months
Evaluation of activity of daily life (Score 0-100)
time frame: 6 months
Number and tipe of medications (composite measure)
time frame: 30 days

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - Person with Alzheimer's disease. Exclusion Criteria: - Bedridden patients.

Additional Information

Official title Effectiveness of Environmental Therapy in Patients With Alzheimer's Disease
Principal investigator Massimo Venturelli, Ph.D.
Description Since Homo sapiens evolved in a natural environment, an intrinsic physiologic and psychological positive reaction to nature has been developed. Accordingly, emerging literature highlights the positive effect of therapeutic gardens, as environmental ecological therapy (EET) on the reduction of behavioral disorders (BD) and the preservation of cognitive functions in patients with Alzheimer's disease (AD). Despite these promising preliminary studies, limited data are available on the effectiveness of EET in individuals with advanced AD. Therefore, the aim of the current trial will be to evaluate the effectiveness of EET on AD symptoms in patients with advanced AD. Participants with advanced AD will be selected from among residents of the Alzheimer's care units of the Mons. Mazzali Foundation (Mantua, Italy). Selected participants will be randomly assigned to a treatment group (TR), or to a control group (CTRL). Participants assigned to TR group will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months. Individuals assigned to the CTRL group will be treated with a standard therapy.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Universita di Verona.