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AgingNCT05145985

Senior Fitness Test - Reference Curves for Polish Women Over 60

An observational study of Aging and Physical Fitness, run by Józef Piłsudski University of Physical Education at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aging of society is a natural process, but it entails challenges in social, economic and health aspects. It is important for mature people to maintain, for as long as possible, adequate functional capacity to live independently and autonomously. Read more about this study

Who is it for?
Ages 60 to 94 years, women onlyHealthy volunteers can take part
Conditions the study is for
Aging, Physical Fitness
What is being tested?
Senior Fitness Test
How many people
833 participants
Where
1 sitePoland
Study dates
1 Mar 2018to 30 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 94 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study group consisted of all individuals who will to participate in the study and meet the specified inclusion conditions.

Who may be able to join

  • gender - female
  • age - over 60
  • able to move independently
  • health condition allowing to perform the agility tests
  • consent to participate in the study

Who cannot join

  • age - under 60
  • unable to move around independently
  • health condition does not allow you to take part in the fitness tests
  • no consent to participate in the study

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • the Józef Piłsudski University of Physical Education

    Warsaw

Other trials in Poland

About this study

Official title: Senior Fitness Test - Proposed Reference Curves for Polish Women Over 60

The aging of society is a natural process, but it entails challenges in social, economic and health aspects. It is important for mature people to maintain, for as long as possible, adequate functional capacity to live independently and autonomously. Presentation of reference values of functional abilities in continuous perspective (and not in 5-year periods as it is in standards for SFT) is a better approach. This approach reflects the process of change that occurs in functional ability. The aim of the study was to develop centile distributions of fitness tests constituting the Senior Fitness Test (SFT) for women over 60 years of age in Poland, moving independently.

Read the detailed description

The aging of society is a natural process, but it entails challenges in social, economic and health aspects. It is important for mature people to maintain, for as long as possible, an adequate functional capacity to live independently and autonomously. In order to determine the level of functional fitness, fitness tests are used. Such tests include the Senior Fitness Test (another name: Fullerton Functional Fitness Test)- tests described below; One Leg Standing Test - test that assesses static balance to diagnose symptoms of mobility disability; Stops Walking When Talking - assesses risk of falling and ability to perform two activities simultaneously (talking and walking), Berg Balance Scale - assesses ability to maintain balance while performing specific tasks, does not assess gait; Four Square Step Test (FSST) - assesses dynamic balance and coordination; Functional Reach Test (FRT) - oceans of dynamic balance; Tinetti Test - oceans of balance during simple tasks and oceans of gait; Short Physical Performance Battery - oceans of balance functioning and lower limb performance in people over 60. age. On the basis of these fitness tests the level of a selected aspect of functional ability is assessed, converting the results into points. Among the indicated tools the Senior Fitness Test seems to be the most universal, as it is a comprehensive and useful tool for multidimensional assessment of physical fitness of people over 60. It allows observation of the gradual decline in functional ability with age. Additionally, the simple tests and norms for the fitness tests in the Senior Fitness Test are defined for people aged 60-94. Publicly available norms were developed for the American population.

The development of reference values for the fitness tests that make up the Senior Fitness Test reflects the process that is taking place in the functional fitness area of people over 60 years of age. Additionally it is possible to observe changes on a continuous basis rather than in 5-year periods. It also allows to catch the moment when functional fitness deterioration occurs.

The main objective was to develop centile grids for fitness tests assessing upper and lower limb muscle strength, flexibility, dynamic balance and endurance, which comprise the Senior Fitness Test for women over 60.

The Senior Fitness Test is a tool used to determine the functional fitness level of people over 60 years of age. In order to determine physical fitness levels, Senior Fitness Test was carried out. The test is comprised of 6 individual test items and for a description of the trials, please refer to Różańska-Kirschke et al. All fitness tests (1-6) were selected for analysis:

  1. Arm Curl (AC) - measurement of upper body muscle endurance.
  2. 30-second Chair Stand (30SCS) - measurement of lower body strength.
  3. Back Scratch Test (BST) - measurement of upper-body flexibility.
  4. Chair Sit and Reach Test (CSRT) - measurement of lower-body flexibility (specifically hamstring flexibility)
  5. 8-Foot Up and Go (TUG) - measurement of agility (dynamic balance) and aerobic endurance.
  6. 2-Minute Walk Test (2MWT) - measurement of (aerobic) endurance.
Being tested
Senior Fitness Test
Keywords
aged, physical fitness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Senior Fitness TestDiagnostic test

    Senior Fitness Test is comprised of 6 individual test items and for a description of the trials. All fitness tests (1-6) were selected for analysis:

    1. Arm Curl (AC) - measurement of upper body muscle endurance - numbers of arm curls as possible in 30 seconds (n)
    2. 30-second Chair Stand (30SCS) - measurement of lower body strength; numbers of chair stand as possible in 30 seconds (n)
    3. Back Scratch Test (BST) - measurement of upper-body flexibility; the best score to the nearest centimeter (cm)
    4. Chair Sit and Reach Test (CSRT)- measurement of lower-body flexibility (specifically hamstring flexibility); the best score to the nearest centimeter (cm)
    5. 8-Foot Up and Go (TUG) - measurement of agility (dynamic balance) and aerobic endurance; the best time of the two trails to the nearest 1/10th second (s)
    6. 2-Minute Walk Test (2MWT) - measurement of (aerobic) endurance; the total number of times the right knee reaches the tape level in two minutes (n)
Study groups in NCT05145985
Study groupRoleWhat they receive
Women over 60Women aged over 60 years. Participants were allowed to participate in the study if they were able to walk independently and their health condition allowed them to perform the indicated fitness tests.
Receives: Diagnostic Test: Senior Fitness Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. determining the level of fitness in individual fitness tests - measure leg strength

    1. The chair stand test - number of completed chair stands in 30 seconds (n) This test assesses leg strength and endurance. Equipment: a straight back or folding chair without arm rests (seat 44 cm high) Test: Place the chair against a wall, or otherwise stabilize it for safety. The subject sits in the middle of the seat, with their feet shoulder width apart, flat on the floor. The arms are to be crossed at the wrists and held close to the chest. From the sitting position, the subject stands completely up, then completely back down, and this is repeated for 30 seconds. Count the total number of complete chair stands (up and down equals one stand). If the subject has completed a full stand from the sitting position when the time is elapsed, the final stand is counted in the total (from Jones \& Rikli, 2002).

    Measured: baseline

  2. determining the level of fitness in individual fitness tests - measure upper body strength

    1. The Arm Curl test - the total number of controlled arm curls performed in 30 seconds (n) Equipment: 2kg weight, a chair without armrests, stopwatch. Test: do as many arm curls as possible in 30 seconds. This test is conducted on the dominant arm side (or stronger side). The subject sits on the chair, holding the weight in the hand using a suitcase grip (palm facing towards the body) with the arm in a vertically down position beside the chair. Brace the upper arm against the body so that only the lower arm is moving (tester may assist to hold the upper arm steady). Curl the arm up through a full range of motion, gradually turning the palm up (flexion with supination). As the arm is lowered through the full range of motion, gradually return to the starting position. Repeat this action as many times as possible within 30 seconds.

    Measured: baseline

  3. determining the level of fitness in individual fitness tests - measure lower body flexibility

    1. The Chair Sit and Reach test - The score is recorded to the nearest 0,5 cm or 1 cm as the distance reached, either a negative or positive score (cm) Equipment: ruler, straight back or folding chair (about 44 cm high) Test: The subject sits on the edge a chair (placed against a wall for safety). One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floor, and ankle bent at 90°. Place one hand on top of the other with tips of the middle fingers even. Instruct the subject to inhale, and then as they exhale, reach forward toward the toes by bending at the hip. Keep the back straight and head up. The distance is measured between the tip of the fingertips and the toes. Measure the distance between the fingers and the toes (a negative score), if they overlap, measure by how much (a positive score).

    Measured: baseline

  4. determining the level of fitness in individual fitness tests - measure general shoulder range of motion

    1. The Back Scratch Test - Record the best score to the nearest centimeter or 0,5 cm. The higher the score the better the result (cm) This test is done in the standing position. Place one hand behind the head and back over the shoulder, and reach as far as possible down the middle of your back, your palm touching your body and the fingers directed downwards. Place the other arm behind your back, palm facing outward and fingers upward and reach up as far as possible attempting to touch or overlap the middle fingers of both hands. An assistant is required to direct the subject so that the fingers are aligned, and to measure the distance between the tips of the middle fingers. If the fingertips touch then the score is zero. If they do not touch, measure the distance between the finger tips (a negative score), if they overlap, measure by how much (a positive score).

    Measured: baseline

  5. determining the level of fitness in individual fitness tests - measure speed, agility and balance while moving

    1. The '8 Foot Up-and-Go' test - Take the best time of the two trails to the nearest 1/10th second (s) equipment: stopwatch, straight back or folding chair (44 cm high) Test: Place the chair next to a wall (for safety) and the marker 8 feet in front of the chair. Clear the path between the chair and the marker. The subject starts fully seated, hands resting on the knees and feet flat on the ground. On the command, "Go," timing is started and the subject stands and walks (no running) as quickly as possible (and safely) to and around the cone, returning to the chair to sit down. Timing stops as they sit down.

    Measured: baseline

  6. determining the level of fitness in individual fitness tests - measure aerobic endurance

    1. The 2-Minute Step in Place test - Record the total number of times the right knee reaches the tape level in two minutes (n) equipment: tape for marking the wall, stopwatch Test: The subject stands up straight next to the wall while a mark is placed on the wall at the level corresponding to midway between the patella (knee cap) and illiac crest (top of the hip bone). The subject then marches in place for two minutes, lifting the knees to the height of the mark on the wall. Resting is allowed, and holding onto the wall or a stable chair is allowed. Stop after two minutes of stepping.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2021
  2. Study start1 Mar 2018
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
833 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05145985
Sponsor's protocol ID
SFT-2021
Status last verified
Nov 2021
First submitted
14 Oct 2021
Last updated
22 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Aging and Physical Fitness, run by Józef Piłsudski University of Physical Education at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

determining the level of fitness in individual fitness tests - measure leg strength (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.

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