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Trial Review
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
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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
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Scientific title
Assessment of functional capacity of the elderly women population
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Secondary ID [1]
314128
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
low functional fitness in elderly women
336935
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Condition category
Condition code
Physical Medicine / Rehabilitation
333403
333403
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0
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Physiotherapy
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
330715
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Not applicable
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340979
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An assessment of lower body strength
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Assessment method [1]
340979
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30-second Chair Stand Test (part no.1 of Senior Fitness Test) – The subject sits on a chair of appropriate height (43 cm). The arms are crossed at chest level. The task is to perform as many correct chair stands as possible in 30 seconds
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Timepoint [1]
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one-time measurement
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Primary outcome [2]
340980
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An assessment of upper body strength.
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Assessment method [2]
340980
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30-second Arm Curl Test (part no. 2 of Senior Fitness Test) –The subject is given a weight on their dominant arm. The weight is 2.27 kg for women and 3.63 kg for men. The task consists of performing as many correct forearm flexions as possible in 30 seconds
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Timepoint [2]
340980
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one-time measurement
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Primary outcome [3]
340981
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An assessment of agility and dynamic balance - one (composite) outcome
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Assessment method [3]
340981
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2-minute walk test (part no. 3 of Senior Fitness test) – The person sits on a chair. There is a cone in front of them and 2.44 m from the chair. On a signal, the person stands up, walks to the cone, walks around it, returns to the chair and sits down. The task should be performed as quickly as possible. The result is the time needed to complete the task
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Timepoint [3]
340981
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one-time measurement
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Secondary outcome [1]
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An assessment of lower body flexibility.
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Assessment method [1]
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Chair sit-and-reach test (part no. 4 of Senior Fitness test)– The person sits on the edge of the chair. One lower limb is straightened and the heel rests on the floor (toes pointing to the ceiling). The other lower limb is bent (the entire foot rests on the floor). The task is to reach the toes with your hands. The distance from the middle finger to the toes is measured. The result is given to the nearest 0.5 cm
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Timepoint [1]
445667
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one-time measurement
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Secondary outcome [2]
445668
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An assessment of the flexibility of the upper body.
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Assessment method [2]
445668
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Back Scratch Test (part no. 5 of Senior Fitness test)– The person stands and places one hand on the back from top to bottom, the other from bottom to top. The person tries to connect the fingers of both hands. The distance between the middle fingers of both hands is measured. The result is given to the nearest 0.5 cm
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Timepoint [2]
445668
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one-time measurement
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Secondary outcome [3]
445669
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Measurement of body height
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Assessment method [3]
445669
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Body height will be measured using a Martin-type anthropometer. The subject will be positioned in a standing position, "at attention", without shoes or socks, and the measurement will be taken from the base to the verte point, with an accuracy of 1 mm.
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Timepoint [3]
445669
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one-time measurement
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Secondary outcome [4]
445670
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Measurement of body weight
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Assessment method [4]
445670
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Body weight will be measured using a Tanita scale with an accuracy of 100 g.
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Timepoint [4]
445670
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one-time measurement
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Eligibility
Key inclusion criteria
About 200 physically inactive women, aged between 60 - 75 years, who gave informed consent to participate in the project.
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Minimum age
60
Years
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Maximum age
75
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last participant enrolment
Anticipated
15/08/2025
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Actual
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Date of last data collection
Anticipated
15/08/2025
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26945
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Poland
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State/province [1]
26945
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Funding & Sponsors
Funding source category [1]
318637
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University
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Name [1]
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University of Physical Culture in Krakow
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Address [1]
318637
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Country [1]
318637
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Poland
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Primary sponsor type
University
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Name
University of Physical Culture in Krakow
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Address
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Country
Poland
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Secondary sponsor category [1]
321054
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None
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Name [1]
321054
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Address [1]
321054
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Country [1]
321054
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317246
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the Bioethics Committee at the District Medical Chamber in Krakow
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Ethics committee address [1]
317246
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ul. Krupnicza 11A, 31-123 Kraków
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Ethics committee country [1]
317246
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Poland
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Date submitted for ethics approval [1]
317246
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13/02/2025
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Approval date [1]
317246
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11/03/2025
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Ethics approval number [1]
317246
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8/KBL/OIL/2025
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Summary
Brief summary
Introduction: 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. Material and Methods: In the project will take part about 200 older physically inactive women aged 60-75 who gave their informed consent to participate in the project. Each subject will have 3 measurements performed: body height measurement (Martin type anthropometer), body weight measurement (Tanita scale) and physical fitness measurement (Senior Fitness Test).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Aneta Bac
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Address
140450
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University of Physical Culture, al. Jana Pawla II 78 31-571 Kraków, Poland
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Country
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Poland
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Phone
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+48 12 683 11 22
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Fax
140450
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Email
140450
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[email protected]
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Contact person for public queries
Name
140451
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Aneta Bac
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Address
140451
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University of Physical Culture, al. Jana Pawla II 78 31-571 Kraków, Poland
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Country
140451
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Poland
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Phone
140451
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+48 12 683 11 22
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Fax
140451
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Email
140451
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[email protected]
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Contact person for scientific queries
Name
140452
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Aneta Bac
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Address
140452
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University of Physical Culture, al. Jana Pawla II 78 31-571 Kraków, Poland
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Country
140452
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Poland
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Phone
140452
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+48 12 683 11 22
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Fax
140452
0
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Email
140452
0
[email protected]
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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.
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