Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001481561
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Green Environments and Healthy Aging: Analysing the Role of Green Infrastructure in the Functional Well-Being of the Elderly -A Pilot Study
Scientific title
Green Environments and Healthy Aging: Analysing the Role of Green Infrastructure in the Functional Well-Being of the Elderly -A Pilot Study
Secondary ID [1] 312616 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiorespiratory disease 334549 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331155 331155 0 0
Physiotherapy
Cardiovascular 331401 331401 0 0
Normal development and function of the cardiovascular system
Respiratory 331402 331402 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Firstly, the participants signed the declaration of informed consent to take part in the study, and after that data concerning sample characterization were collected.
On the assessment day, parameters such as heart rate, blood pressure, O2 saturation, analysis of physical capacity (IPAQ), risk of falls (Morse Fall Scale), MinimentalStateExam, and perception of accessibility (Perception of Pedestrian Accessibility Scale for adults over 65) were collected.
All the questionnaires were filled in privately and handed in on the same day. After completing the documents participants were randomly divided into 2 groups, randomization was done using the software www.randomizer.org.
Regarding the environmental characteristics of the two selected areas temperature conditions were recorded every 300m (thermometer). To obtain the environmental noise data, a tripod, a class 1 acoustic calibrator, and a class 1 integrating sound level meter were used, by International Recommendation No. 88 of the International Organization for Legal Metrology (OIML) and the international standard IEC 61672. The sound level meter used is a CESVA model SC310, approved by ISQ. For the ambient noise measurements, the tripod was used at a height of 1.5m off the ground, with the microphone slightly raised. To evaluate the equivalent continuous sound level indicator (Leq), the statistical indicators L5 and L95, were measured, and the presence or absence of impulsive characteristics, using the A-weighted filter.
Three ambient noise measurement points were established along each pedestrian route to assess the experience of walking in rural and urban areas. Different characteristics, such as sidewalk type and surroundings, were considered to better represent each route. At each point, two 10-minute continuous noise measurements were conducted, resulting in a total of 60 minutes of measurement on each route. The measurements were carried out on May 25, 2023, from 3:30 pm to 8:30 pm.
Air quality was obtained from data provided by the air quality monitoring station of Guimarães to the study sites and from the air quality chart of the municipality of Guimarães.

Task
Participants of both groups were asked to walk twice a week, for six weeks, on two routes, one urban with 1,6km long, at speed which participants considered comfortable, with portable pulse oximeters with direct observation.
Intervention code [1] 329125 0
Lifestyle
Intervention code [2] 329316 0
Treatment: Other
Comparator / control treatment
The other route was one rural, at a speed they considered comfortable, with each route being at least 1.6 km long, always accompanied by the researchers monitoring with portable pulse oximeters with direct observation. All participants were duly insured against personal injury.
Control group
Active

Outcomes
Primary outcome [1] 338913 0
cardiovascular pathology
Timepoint [1] 338913 0
Baseline and 6 weeks later (post-intervention commencement)
Primary outcome [2] 338914 0
satisfactory cognitive analysis for the exercise
Timepoint [2] 338914 0
Baseline and 6 weeks later (post-intervention commencement)
Primary outcome [3] 338919 0
perception of accessibility
Timepoint [3] 338919 0
Baseline and 6 weeks later (post-intervention commencement)
Secondary outcome [1] 437896 0
O2 saturation
Timepoint [1] 437896 0
Baseline and 6 weeks later (post-intervention commencement)

Eligibility
Key inclusion criteria
The eligibility criteria included individuals aged 65 or over, with no serious cardiovascular pathology, absence of chronic musculoskeletal symptoms (Physical Performance Test) that made walking difficult, with satisfactory cognitive analysis for the exercise (Mini-MentalStateExam - Folstein).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
exclusion criteria were: very active individuals (IPAQ assessment) as well as individuals with poor adherence to the project.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/06/2023
Date of last participant enrolment
Anticipated
Actual
6/06/2023
Date of last data collection
Anticipated
Actual
25/07/2023
Sample size
Target
40
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 26458 0
Portugal
State/province [1] 26458 0
BRAGA

Funding & Sponsors
Funding source category [1] 317047 0
Government body
Name [1] 317047 0
Green Gap project - Interreg (0029_GREEN_GAP_1_E) and Laboratório da Paisagem. 0029_GREEN_GAP_1_E is co-financed by the European Regional Development Fund (ERDF) under the Interreg VI A Spain – Portugal (POCTEP) 2021-2027 pr
Country [1] 317047 0
Portugal
Primary sponsor type
Other Collaborative groups
Name
LABORATORIO DA PAISAGEM
Address
Country
Portugal
Secondary sponsor category [1] 319294 0
Individual
Name [1] 319294 0
Andrea Ribeiro, ISAVE
Address [1] 319294 0
Country [1] 319294 0
Portugal

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315801 0
Comissão de ética do Centro Interdisciplinar em Ciências da Saúde-ISAVE
Ethics committee address [1] 315801 0
Ethics committee country [1] 315801 0
Portugal
Date submitted for ethics approval [1] 315801 0
26/04/2023
Approval date [1] 315801 0
05/05/2023
Ethics approval number [1] 315801 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135842 0
Prof Andrea Ribeiro
Address 135842 0
Andrea Ribeiro, ISAVE- Instituto Superior de Saúde, Rua Castelo de Almourol, nº13, 4720-155 Amares-Braga Portugal
Country 135842 0
Portugal
Phone 135842 0
+351967441378
Fax 135842 0
Email 135842 0
[email protected]
Contact person for public queries
Name 135843 0
Andrea Ribeiro
Address 135843 0
Andrea Ribeiro ISAVE - Instituto Superior de Saúde, Rua Castelo de Almourol, nº 13 4720-155 Amares – Braga Portugal
Country 135843 0
Portugal
Phone 135843 0
+351967441378
Fax 135843 0
Email 135843 0
[email protected]
Contact person for scientific queries
Name 135844 0
Andrea Ribeiro
Address 135844 0
Andrea Ribeiro ISAVE - Instituto Superior de Saúde, Rua Castelo de Almourol, nº 13 4720-155 Amares – Braga Portugal
Country 135844 0
Portugal
Phone 135844 0
+351967441378
Fax 135844 0
Email 135844 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.