Trial Review

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000592448
Ethics application status
Approved
Date submitted
3/04/2025
Date registered
10/06/2025
Date last updated
10/06/2025
Date data sharing statement initially provided
10/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of functional capacity of the elderly women population
Scientific title
Assessment of functional capacity of the elderly women population
Secondary ID [1] 314128 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low functional fitness in elderly women 336935 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333403 333403 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Obtaining an assessment of the level of functional capacity in older women

2. Functional fitness of the elderly is the ability to safely and independently perform everyday life tasks without excessive effort. The assessment of this fitness is currently the standard for general geriatric assessment and the starting point for not only physical but also social rehabilitation. Periodic determination of the level of functional fitness in smaller and larger populations of elderly people is necessary not only from the point of view of rehabilitation itself but also from the level of broadly understood social care and finances allocated to help the elderly. Numerous tools are used to assess the level of functional fitness, among which the Senior Fitness Test is recommended.

3. Participants: approximately 200 older physically inactive women aged 60-75 who gave their informed consent to participate in the project

4. Procedure:
• Body height measurement - Martin anthropometer, measurement accuracy up to 0.1 cm, measurement from the apex point to the base point, in a standing position, barefoot
• Body weight measurement - Tanita scale, measurement accuracy up to 0.1 kg, measurement method - bioelectric impedance, barefoot
• Functional fitness measurement - Senior Fitness Test, measurement using 5 tests:
- 30-second Chair Stand Test
- 30-second Arm Curl Test
- 2-minute walk test (2-minute step test)
- Chair sit-and-reach test
- Back Scratch Test
Each patient will be assess only once, duration of the single examination – about 5 – 7 minutes.

5. Provider of all examinations - physiotherapist (professor degree)

6. Model of delivery: face to face

7. Type of location where the examination occurred - Central Research and Development Laboratory, University of Physical Culture in Krakow, Poland
Intervention code [1] 330715 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340979 0
An assessment of lower body strength
Timepoint [1] 340979 0
one-time measurement
Primary outcome [2] 340981 0
An assessment of agility and dynamic balance - one (composite) outcome
Timepoint [2] 340981 0
one-time measurement
Primary outcome [3] 340980 0
An assessment of upper body strength.
Timepoint [3] 340980 0
one-time measurement
Secondary outcome [1] 445670 0
Measurement of body weight
Timepoint [1] 445670 0
one-time measurement
Secondary outcome [2] 445669 0
Measurement of body height
Timepoint [2] 445669 0
one-time measurement
Secondary outcome [3] 445667 0
An assessment of lower body flexibility.
Timepoint [3] 445667 0
one-time measurement
Secondary outcome [4] 445668 0
An assessment of the flexibility of the upper body.
Timepoint [4] 445668 0
one-time measurement

Eligibility
Key inclusion criteria
About 200 physically inactive women, aged between 60 - 75 years, who gave informed consent to participate in the project.
Minimum age
60 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injuries to the musculoskeletal system up to 12 months before participating in the study; dizziness up to 3 days before participating in the study; headaches on the day of the examination; pain in the musculoskeletal system up to 3 days before the examination; cognitive impairment; contraindications to physical exertion

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
15/08/2025
Actual
Date of last data collection
Anticipated
15/08/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 26945 0
Poland
State/province [1] 26945 0

Funding & Sponsors
Funding source category [1] 318637 0
University
Name [1] 318637 0
University of Physical Culture in Krakow
Country [1] 318637 0
Poland
Primary sponsor type
University
Name
University of Physical Culture in Krakow
Address
Country
Poland
Secondary sponsor category [1] 321054 0
None
Name [1] 321054 0
Address [1] 321054 0
Country [1] 321054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317246 0
the Bioethics Committee at the District Medical Chamber in Krakow
Ethics committee address [1] 317246 0
Ethics committee country [1] 317246 0
Poland
Date submitted for ethics approval [1] 317246 0
13/02/2025
Approval date [1] 317246 0
11/03/2025
Ethics approval number [1] 317246 0
8/KBL/OIL/2025

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

Contacts
Principal investigator
Name 140450 0
Prof Aneta Bac
Address 140450 0
University of Physical Culture, al. Jana Pawla II 78 31-571 Kraków, Poland
Country 140450 0
Poland
Phone 140450 0
+48 12 683 11 22
Fax 140450 0
Email 140450 0
[email protected]
Contact person for public queries
Name 140451 0
Aneta Bac
Address 140451 0
University of Physical Culture, al. Jana Pawla II 78 31-571 Kraków, Poland
Country 140451 0
Poland
Phone 140451 0
+48 12 683 11 22
Fax 140451 0
Email 140451 0
[email protected]
Contact person for scientific queries
Name 140452 0
Aneta Bac
Address 140452 0
University of Physical Culture, al. Jana Pawla II 78 31-571 Kraków, Poland
Country 140452 0
Poland
Phone 140452 0
+48 12 683 11 22
Fax 140452 0
Email 140452 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The study is not designed to share individual participant data. Results will be published in scientific journal.



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.