Healthy AdultsNCT06533943
Blue-green Space Physical Activity: the "Parco Del Mare" Study
A study testing Exercise program in people with Healthy Adults and Natural Outdoor Environment, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Natural Outdoor Environment, Health Promotion
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult population aged >18 years old
- Resident in Rimini
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Parco del Mare
Rimini, Rimini, 47921
Sofia Marini, PhD, 3391324942 ext. +39, sofia.marini@unich.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise program
- Keywords
- blue-green space setting, physical activity intervention, outdoor exercise, public health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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). Receives: Other: Exercise program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
12-Item Short Form Survey (SF-12)
Quality of Life measurement (higher scores indicate better physical and mental components)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Feb 2022
- Primary completion31 Aug 2024
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Marini, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533943
- Sponsor's protocol ID
- 0121439
- Status last verified
- Dec 2024
- First submitted
- 24 Jul 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06533943
- Acronym / sponsor ID
- 0121439
- Keywords
- blue-green space setting, physical activity intervention, outdoor exercise, public health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 1 Aug 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Exercise programParticipants 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). |
| Control Group | No intervention | –The control group (CG) will be asked to abstain from structured exercise or training, limiting their physical effort to activities needed for daily life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult population aged >18 years old
- Resident in Rimini
Key exclusion criteria (1 listed)
- 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)
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 |
|---|---|---|
| Exercise programEach 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. | Other | Experimental group |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Healthy Participants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Healthy Adults and Natural Outdoor Environment, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Marini, PhD (3391324942 ext. +39, sofia.marini@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Item Short Form Survey (SF-12) (time frame: through study completion, an average of 1 year). 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 13 Dec 2024.