- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624921
PHENOTYPE. Therapeutic Study in Barcelona
Positive Health Effects of the Natural Outdoor Environment in Typical Populations in Different Regions in Europe. Work Package 4: Therapeutic Study in Barcelona
The study aimed to explore therapeutic effects of natural environments. To do so, the investigators evaluated the immediate and sustained changes in several indicators of well-being while people (n=26) with poor mental health were engaged in unconstrained exposures to natural (green, blue) and urban environments. The indicators included: affection, cognition, physiological responses.
Each participant was exposed to all environments for a period of 210 minutes between October 2013 and January 2014. During the exposure period, participants were instructed to do what they would usually do in that environment. Before, during (at 30 and 210 minutes) and after each exposure, several psycho-physiological measures were taken: (i) heart rate variability and heart rate using a Holter monitor, (ii) blood pressure using a digital blood pressure monitor, (iii) physical activity using the CalFIT application installed in a Smartphone, (iv) lung function using a portable computerized spirometer, (v) stress level using salivary cortisol samples collected using Salivettes, (vi) affect, perceived restoration and social interactions using questionnaires, (vii) cognitive functioning using the backwards digit-span task test.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- MHI-5 scored in the lower 50th percentile of the Barcelona city PHENOTYPE sample
- willing to participate
Exclusion Criteria:
- no able to walk for 30 minutes at self-directed pace.
- with chest, abdomen surgery or heart attack during the last three months.
- with retinal detachment or eyes surgery or hospitalized for heart problem during the last month.
- with tuberculosis treatment, or respiratory infection during the last three weeks.
- being asthmatic or pregnant
- using inhaler the 24 hours previous to the study day.
- taking medication different from the usual the 24 hours previous to the study day.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline heart rate variability at 30 min
Time Frame: after 30 minutes of exposure to green/blue/urban environment
|
after 30 minutes of exposure to green/blue/urban environment
|
Change from Baseline heart rate at 30 min
Time Frame: after 30 minutes of exposure to green/blue/urban environment
|
after 30 minutes of exposure to green/blue/urban environment
|
Change from blood pressure at 30min
Time Frame: after 30 minutes of exposure to green/blue/urban environment
|
after 30 minutes of exposure to green/blue/urban environment
|
Change from stress level at 30min (salivary cortisol)
Time Frame: after 30 of exposure to green/blue/urban environment
|
after 30 of exposure to green/blue/urban environment
|
Change from affect at 30 min (BRUMS/POMS)
Time Frame: after 30 minutes of exposure to green/blue/urban environment
|
after 30 minutes of exposure to green/blue/urban environment
|
Change from cognitive functioning at 30 min (backward digit span task)
Time Frame: after 30 minutes of exposure to green/blue/urban environment
|
after 30 minutes of exposure to green/blue/urban environment
|
Change from Baseline heart rate variability at 210 min
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
after 210 minutes of exposure to green/blue/urban environment
|
Change from Baseline heart rate at 210 min
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
after 210 minutes of exposure to green/blue/urban environment
|
Change from blood pressure at 210min
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
after 210 minutes of exposure to green/blue/urban environment
|
Change from stress level at 210min (salivary cortisol)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
after 210 minutes of exposure to green/blue/urban environment
|
Change from affect at 210 min (BRUMS/POMS)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
after 210 minutes of exposure to green/blue/urban environment
|
Change from cognitive functioning at 210 min (backward digit span task)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
after 210 minutes of exposure to green/blue/urban environment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objectively measured physical activity 30
Time Frame: During the first 30 minutes of exposure to green/blue/urban environment
|
Measured with a Smartphone application (CalFIT)
|
During the first 30 minutes of exposure to green/blue/urban environment
|
perceived restoration 30 (ROS - Korpela's Restoration outcome scale)
Time Frame: after 30 minutes of exposure to green/blue/urban environment
|
after 30 minutes of exposure to green/blue/urban environment
|
|
subjectively recorded social interactions 30
Time Frame: after 30 minutes of exposure to green/blue/urban environment
|
Measurement tool developed by the research team
|
after 30 minutes of exposure to green/blue/urban environment
|
ambient air pollution exposure 30 (PM2.5)
Time Frame: During the first 30 minutes of exposure to green/blue/urban environment
|
Measured with MicroAthelometer
|
During the first 30 minutes of exposure to green/blue/urban environment
|
objectively measured physical activity 210
Time Frame: During the first 210 minutes of exposure to green/blue/urban environment
|
Measured with a Smartphone application (CalFIT)
|
During the first 210 minutes of exposure to green/blue/urban environment
|
perceived restoration 210 (ROS- Korpela's Restoration outcome scale)
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
after 210 minutes of exposure to green/blue/urban environment
|
|
subjectively recorded social interactions 210
Time Frame: after 210 minutes of exposure to green/blue/urban environment
|
Measurement tool developed by the research team
|
after 210 minutes of exposure to green/blue/urban environment
|
ambient air pollution exposure 210 (PM2.5)
Time Frame: During the first 210 minutes of exposure to green/blue/urban environment
|
Measured with MicroAthelometer
|
During the first 210 minutes of exposure to green/blue/urban environment
|
personal air pollution (CO, NO, NO2)
Time Frame: During all the data collection day
|
Personal sensors designed and built at Cambridge University, UK (CamPerS)
|
During all the data collection day
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PHENOTYPE_WP4BCN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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