Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001018101
Ethics application status
Approved
Date submitted
7/05/2019
Date registered
16/07/2019
Date last updated
16/07/2019
Date data sharing statement initially provided
16/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reliability of the community settings outdoor walking test with GPS device for the walking abilities assessment in young and older people.
Scientific title
Test–retest reliability of the community settings outdoor walking test with GPS device evaluation in young and older adults.
Secondary ID [1] 298149 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
walking abilities 312695 0
Condition category
Condition code
Public Health 311196 311196 0 0
Health promotion/education
Musculoskeletal 311197 311197 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will be conducted at the Poznan University of Physical Eduaction in Gorzow Wielkopolski. Following recruitment of eligible healthy young and older adults, the participants will be required to take part in a community settings outdoor walking test with GPS device, a balance test (Short Physical Performance Battery), physical activity assessment (PASE questionnairre), grip strength (grip meter), quality of life (SF36, WHOQO) - BREF, EQ-5D-5L), bodyfat percentage (Bioelectric Impedance Analysis (BIA) technology). Participants will be required to complete the community settings outdoor walking test with GPS device on one day, and the rest of the tests on a second, consecutive day. The community settings outdoor walking test with GPS device will be performed twice – the second study will be conducted one week later. Each outdoor walking test with GPS device will last for 60 minutes. The GPS device will be worn on a wrist. Patients will be asked to walk with self-selected, usual pace. The physiotherapist will start the device and stop it after each test.
Intervention code [1] 314372 0
Not applicable
Comparator / control treatment
There is 'no comparator/control treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319955 0
total walking distance (community settings outdoor walking test with GPS device)
Timepoint [1] 319955 0
Day of testing
Primary outcome [2] 319956 0
static balance (Short Physical Performance Battery)
Timepoint [2] 319956 0
day of testing
Primary outcome [3] 319957 0
grip strength (dynamometer)
Timepoint [3] 319957 0
Day of testing
Secondary outcome [1] 369984 0
quality of life (SF36, WHOQOL - BREF, EQ-5D-5L) - a composite secondary outcome
Timepoint [1] 369984 0
Day of testing
Secondary outcome [2] 369985 0
bodyfat percentage (Bioelectric Impedance Analysis (BIA) technology)
Timepoint [2] 369985 0
Day of testing
Secondary outcome [3] 369986 0
physical activity (PASE questionnairre)
Timepoint [3] 369986 0
Day of testing

Eligibility
Key inclusion criteria
1. Between 20 -25 years old (younger group) and 65 or more years old (older group).
2. Without serious medical conditions limiting participation in any of required tests, such as unstable angina, uncontrolled hypertension, chest pain, heart attack or heart surgery in the past 6 months, low back pain, osteoarthiris, balance disorders,
3. Participants with appropriate cognitive skills to provide informed consent and follow instructions for the required tests.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Serious medical conditions limiting participation in any of required tests, such as unstable angina, uncontrolled hypertension, chest pain, heart attack or heart surgery in the past 6 months, low back pain, osteoarthiris, balance disorders,

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/07/2019
Date of last participant enrolment
Anticipated
21/10/2019
Actual
Date of last data collection
Anticipated
1/11/2019
Actual
Sample size
Target
120
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 21453 0
Poland
State/province [1] 21453 0
lubuskie

Funding & Sponsors
Funding source category [1] 302676 0
University
Name [1] 302676 0
Poznan University School of Physical Education, Gorzow Wielkopolski
Country [1] 302676 0
Poland
Primary sponsor type
University
Name
Poznan University School of Physical Education, Gorzow Wielkopolski
Address
Poznan University School of Physical Education, Gorzow Wielkopolski, ul. Eskowskiego 13, 66-400 Gorzow Wielkopolski
Country
Poland
Secondary sponsor category [1] 302606 0
None
Name [1] 302606 0
Address [1] 302606 0
Country [1] 302606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303297 0
Bioethics committee - Poznan University of Medical Sciences
Ethics committee address [1] 303297 0
Komisja Bioetyczna przy Uniwersytecie Medycznym im. Karola Marcinkowskiego w Poznaniu, ul. Bukowska 70, pok A204, 60-812 Poznan
Ethics committee country [1] 303297 0
Poland
Date submitted for ethics approval [1] 303297 0
Approval date [1] 303297 0
11/04/2019
Ethics approval number [1] 303297 0
471/19

Summary
Brief summary
The main aim of the study is to assess the reliability of the community settings outdoor walking test with GPS device among young and older adults. 120 subjects (women and men) are planning to take part in the research. After enrollment, all subjects twice will undergo assessment of total walking distance (km) in community settings outdoor walking test with GPS device.
We assume that the community settings outdoor walking test with GPS device will be a reliable tool for an objective assessment of the walking abilities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93178 0
Dr Anita Kulik
Address 93178 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6
66-400 Gorzow Wielkopolski
Country 93178 0
Poland
Phone 93178 0
+48957279222
Fax 93178 0
Email 93178 0
[email protected]
Contact person for public queries
Name 93179 0
Anita Kulik
Address 93179 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6
66-400 Gorzow Wielkopolski
Country 93179 0
Poland
Phone 93179 0
+48957279222
Fax 93179 0
Email 93179 0
[email protected]
Contact person for scientific queries
Name 93180 0
Anita Kulik
Address 93180 0
Zamiejscowy Wydzial Kultury Fizycznej
ul. Orlat Lwowskich 4-6
66-400 Gorzow Wielkopolski
Country 93180 0
Poland
Phone 93180 0
+48957279222
Fax 93180 0
Email 93180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.