- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06533943
Blue-green Space Physical Activity: the "Parco Del Mare" Study
December 9, 2024 updated by: Sofia Marini, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Engaging in Physical Activity Carried Out in a Blue-green Space to Improve Health, Quality of Life and Physical Performance Among the Population: the "Parco Del Mare" Study Protocol
This study protocol, describe the innovative study intervention which will be performed in a green-blue space in Italy in order to investigate on the improvements in wellbeing following participation in the study.
This will be significant because it will provide evidence on the effectiveness of the supervised physical activities carried out in green-blue space in improving health, quality of life, physical performance, anthropometric outcomes and physiological parameters in adults, indicating the reasonableness for public health authorities to developing such activities.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The aim of the "Parco del Mare" pilot study is to evaluate the feasibility and the effects of a moderate-intensity exercise program carried out in a green-blue space, on health outcomes such as quality of life and physical performance.
Healthy adults with no contraindication to practice physical activity will be recruited and divided into two groups: the experimental group involved in the exercise sessions performed twice a week for 6-months, while the control group received no intervention.
Validated tests and questionnaires will be used to detect health parameters at baseline (T0) and follow-up (T1).
The investigators expected the intervention carried out in the Parco del Mare setting to be feasible and effective in improving health parameters, quality of life and physical performance in healthy adults.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sofia Marini, PhD
- Phone Number: +39 3391324942
- Email: sofia.marini@unich.it
Study Locations
-
-
-
Rimini, Italy, 47921
- Recruiting
- Parco del Mare
-
Contact:
- Sofia Marini, PhD
- Phone Number: +39 3391324942
- Email: sofia.marini@unich.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adult population aged >18 years old
- Resident in Rimini
Exclusion Criteria:
- Any alterations in communication skills and/or sensory functions so severe as to make it impossible to understand and/or execute the instructions given by the trainer (dementia, aphasia, blindness, deafness)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Participants in the experimental group (EG) undergo the exercise program designed for the purpose of the study.
The outdoor sessions will be carried out in groups (2 sessions per week, lasting 1 hour each one) and administered by trainers with a master's degree in Science and Technique of Preventive and Adapted Physical Activity (kinesiologists).
|
Each intervention session is divided into three different parts according to the specific aim such as warm-up (about 15 minutes) at the beginning, main exercises (about 30 minutes), and stretching and relaxation (about 15 minutes) at the end.
|
|
No Intervention: Control Group
The control group (CG) will be asked to abstain from structured exercise or training, limiting their physical effort to activities needed for daily life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12-Item Short Form Survey (SF-12)
Time Frame: through study completion, an average of 1 year
|
Quality of Life measurement (higher scores indicate better physical and mental components)
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
August 31, 2024
Study Completion (Estimated)
December 20, 2024
Study Registration Dates
First Submitted
July 24, 2024
First Submitted That Met QC Criteria
July 29, 2024
First Posted (Actual)
August 1, 2024
Study Record Updates
Last Update Posted (Estimated)
December 13, 2024
Last Update Submitted That Met QC Criteria
December 9, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 0121439
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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