Physical FitnessNCT05106348
Methods of Assessing Fitness and Physical Capacity
An observational study of Physical Fitness, run by Jolanta Marszałek at 1 site in Poland.
Trial summary
Aerobic fitness is an important part of sport training preparation for wheelchair rugby players. Currently, there are some test protocols on arm crank ergometer for spinal cord injury people. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness
- What is being tested?
- Aerobic Fitness Test
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 13 Mar 2020to 30 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: the elite wheelchair rugby players (Polish National Team players) group is a small group of population
Who may be able to join
- wheelchair rugby players - elite athletes, national team athletes
Who cannot join
- not healthy participant
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jozef Pilsudski University of Physical Education in Warsaw
Warsaw, Masovian Voivodeship, 00-968
About this study
Official title: Methods of Assessing Fitness and Physical Capacity of People With Special Needs - Searching for Guidelines and Methods for Measuring the Population of People With Impairments
Aerobic fitness is an important part of sport training preparation for wheelchair rugby players. Currently, there are some test protocols on arm crank ergometer for spinal cord injury people. However, wheelchair propulsion seems to be better and more specific movement to assess aerobic fitness in wheelchair rugby player. Thus, this pilot study was designed to determine the reliability of the aerobic fitness test protocol on a wheelchair ergometer for wheelchair rugby players.
Methods Ten wheelchair rugby players (C5/6 = 4, C6/C7 = 3, C7/th1 = 1 all with incomplete lesions, cerebral palsy (CP) = 1; dysmelia = 1; mean age = 32,90 yr. ± 5,17; body mass = 70,04 kg ± 12,53; body height = 177,70 cm ± 18,64) participated in the aerobic fitness test on the Lode Esseda wheelchair ergometer (LEM Software 10.12, Groningen, Netherlands). This test involved different considering players' International Wheelchair Rugby Federation (IWRF) class (class 0.5 = 4 players, classes 1.0-1.5 = 6 players, and classes 2.0-3.5 = 8 players) increments of workload every minute at constant velocity of 4.5 km/h. Peak oxygen uptake (V̇O2peak l/min, V̇O2peak ml/kg/min), minute ventilation (VE), and the test time achieved were collected (Cortex Metamax). The load [N, Watts] from the last fully achieved level in the test was noticed. Participants repeated the aerobic fitness test twice with 24h break. Each player had 10 minutes warm-up before the test. Differences (T-test for independent groups or Wilcoxon test) and correlations (Pearson test or Spearman test) between results from the first and the second repetition of the test (fully achieved load level in the test) were calculated to establish reliability. The intra-class correlation coefficients (ICC) and standard error of measurement (SEM) were added. The significance level was set at p<.05
Read the detailed description
"the Lode Esseda" is the name of a wheelchair ergometer.
- Conditions
- Physical Fitness
- Being tested
- Aerobic Fitness Test
- Keywords
- Capacity, Aerobic Fitness, Protocol, Wheelchair Rugby, Impairments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Fitness TestDiagnostic test
aerobic fitness test to assess wheelchair rugby players capacity
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair Rugby Group | wheelchair rugby players, elite athletes, national team athletes Receives: Diagnostic Test: Aerobic Fitness Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
aerobic fitness test
Determination the reliability of the aerobic fitness test protocol on a wheelchair ergometer for wheelchair rugby players.
Measured: 13.03.2020-30.06.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start13 Mar 2020
- Primary completion21 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jolanta Marszałek
- Sponsor type
- University, hospital or other
- Collaborators
- Polish Wheelchair Rugby Federation
- Responsible party
- Sponsor-investigator, Jolanta Marszałek, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106348
- Sponsor's protocol ID
- SKE 01-01/2020 (1)
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods of Assessing Fitness and Physical Capacity of People With Special Needs - Searching for Guidelines and Methods for Measuring the Population of People With Impairments
- ClinicalTrials.gov ID
- NCT05106348
- Acronym / sponsor ID
- SKE 01-01/2020 (1)
- Conditions
- Physical Fitness
- Keywords
- Capacity, Aerobic Fitness, Protocol, Wheelchair Rugby, Impairments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jolanta MarszałekUniversity, hospital or other
- Collaborators
- Polish Wheelchair Rugby Federation
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aerobic fitness is an important part of sport training preparation for wheelchair rugby players. Currently, there are some test protocols on arm crank ergometer for spinal cord injury people. However, wheelchair propulsion seems to be better and more specific movement to assess aerobic fitness in wheelchair rugby player. Thus, this pilot study was designed to determine the reliability of the aerobic fitness test protocol on a wheelchair ergometer for wheelchair rugby players.
Methods Ten wheelchair rugby players (C5/6 = 4, C6/C7 = 3, C7/th1 = 1 all with incomplete lesions, cerebral palsy (CP) = 1; dysmelia = 1; mean age = 32,90 yr. ± 5,17; body mass = 70,04 kg ± 12,53; body height = 177,70 cm ± 18,64) participated in the aerobic fitness test on the Lode Esseda wheelchair ergometer (LEM Software 10.12, Groningen, Netherlands). This test involved different considering players' International Wheelchair Rugby Federation (IWRF) class (class 0.5 = 4 players, classes 1.0-1.5 = 6 players, and classes 2.0-3.5 = 8 players) increments of workload every minute at constant velocity of 4.5 km/h. Peak oxygen uptake (V̇O2peak l/min, V̇O2peak ml/kg/min), minute ventilation (VE), and the test time achieved were collected (Cortex Metamax). The load [N, Watts] from the last fully achieved level in the test was noticed. Participants repeated the aerobic fitness test twice with 24h break. Each player had 10 minutes warm-up before the test. Differences (T-test for independent groups or Wilcoxon test) and correlations (Pearson test or Spearman test) between results from the first and the second repetition of the test (fully achieved load level in the test) were calculated to establish reliability. The intra-class correlation coefficients (ICC) and standard error of measurement (SEM) were added. The significance level was set at p<.05
Detailed description
"the Lode Esseda" is the name of a wheelchair ergometer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wheelchair Rugby Group | – | Diagnostic Test: Aerobic Fitness Testwheelchair rugby players, elite athletes, national team athletes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the elite wheelchair rugby players (Polish National Team players) group is a small group of population
Key inclusion criteria (1 listed)
- wheelchair rugby players - elite athletes, national team athletes
Key exclusion criteria (1 listed)
- not healthy participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Fitness Testaerobic fitness test to assess wheelchair rugby players capacity | Diagnostic test | Wheelchair Rugby Group |
Primary outcome
aerobic fitness test
Time frame: 13.03.2020-30.06.2021
Determination the reliability of the aerobic fitness test protocol on a wheelchair ergometer for wheelchair rugby players.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Fitness, run by Jolanta Marszałek 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 1 inclusion and 1 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 12 Nov 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?
aerobic fitness test (time frame: 13.03.2020-30.06.2021). 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 12 Nov 2021.