NCT06533943

Brief 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. 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.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

July 24, 2024

Last Update Submit

December 9, 2024

Conditions

Keywords

blue-green space settingphysical activity interventionoutdoor exercisepublic health

Outcome Measures

Primary Outcomes (1)

  • 12-Item Short Form Survey (SF-12)

    Quality of Life measurement (higher scores indicate better physical and mental components)

    through study completion, an average of 1 year

Study Arms (2)

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).

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult population aged \>18 years old
  • Resident in Rimini

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parco del Mare

Rimini, Rimini, 47921, Italy

RECRUITING

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sofia Marini, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 1, 2024

Study Start

February 1, 2022

Primary Completion

August 31, 2024

Study Completion

December 20, 2024

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations