Energy Supply; DeficiencyNCT04254900
Energy Availability in Male and Female Elite Wheelchair Athletes Over Seven Consecutive Training Days
An observational study of Energy Supply; Deficiency, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Low energy availability (LEA) is a major problem in sports as athletes ingest often a lower amount of energy compared to their actual needs. The availability of energy is calculated based on their daily energy intake and the energy cost of the daily training sessions in relation to their fat-free mass. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Supply; Deficiency
- What is being tested?
- evaluating energy availability
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2019to 1 Mar 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Elite wheelchair athletes from national team in different wheelchair sports
Who may be able to join
- athletes from a national team in wheelchair sports
Who cannot join
- unable to follow normal training routine
- unable to record diet or training
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Energy Availability in Wheelchair Athletes
Low energy availability (LEA) is a major problem in sports as athletes ingest often a lower amount of energy compared to their actual needs. The availability of energy is calculated based on their daily energy intake and the energy cost of the daily training sessions in relation to their fat-free mass. Based on this calculation, it is known how much energy will available for the body (beside the fuel for training) to keep it in optimal physiological functioning. It has been shown, that LEA occurs very often in female athletes, in endurance athletes as well as athletes in weight-sensitive sports (i.e. jockeys, combat sports, gymnastics, ballet). The purpose of this study was to investigate, whether LEA is a problem in wheelchair athletes as well.
Read the detailed description
Energy availability will be assessed over 7 consecutive training days using a dietary and training record as well as the Leisure Time PHysical Activity Questionnaire for spinal cord injury. Resting Energy expenditure will be measured as well as body composition (by a DXA) before the start of data collection.
- Conditions
- Energy Supply; Deficiency
- Being tested
- evaluating energy availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluating energy availabilityOther
energy availability will be determined by measuring energy intake, exercise energy expenditure and fat-free mass and using the following formula: energy availability = (energy intake - exercise energy expenditure) / fat-free mass
| Study group | Role | What they receive |
|---|---|---|
| Male wheelchair athletes | Other Receives: Other: evaluating energy availability | |
| Female wheelchair athletes | Other Receives: Other: evaluating energy availability |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy availability
energy availability = (energy intake - exercise energy expenditure) / fat-free mass. Energy intake and exercise energy expenditure are measured using a food and training diary. The fat-free mass will be measured using a DXA scan.
Measured: 7 consecutive days during pre-season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy Supply; DeficiencyStudies 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
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Joelle Flueck, PhD, Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254900
- Sponsor's protocol ID
- 2018-35
- Status last verified
- Mar 2020
- First submitted
- 3 Feb 2020
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Availability in Wheelchair Athletes
- ClinicalTrials.gov ID
- NCT04254900
- Acronym / sponsor ID
- 2018-35
- Conditions
- Energy Supply; Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (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.
Low energy availability (LEA) is a major problem in sports as athletes ingest often a lower amount of energy compared to their actual needs. The availability of energy is calculated based on their daily energy intake and the energy cost of the daily training sessions in relation to their fat-free mass. Based on this calculation, it is known how much energy will available for the body (beside the fuel for training) to keep it in optimal physiological functioning. It has been shown, that LEA occurs very often in female athletes, in endurance athletes as well as athletes in weight-sensitive sports (i.e. jockeys, combat sports, gymnastics, ballet). The purpose of this study was to investigate, whether LEA is a problem in wheelchair athletes as well.
Detailed description
Energy availability will be assessed over 7 consecutive training days using a dietary and training record as well as the Leisure Time PHysical Activity Questionnaire for spinal cord injury. Resting Energy expenditure will be measured as well as body composition (by a DXA) before the start of data collection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male wheelchair athletes | – | Other: evaluating energy availabilityOther |
| Female wheelchair athletes | – | Other: evaluating energy availabilityOther |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Elite wheelchair athletes from national team in different wheelchair sports
Key inclusion criteria (1 listed)
- athletes from a national team in wheelchair sports
Key exclusion criteria (2 listed)
- unable to follow normal training routine
- unable to record diet or training
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 |
|---|---|---|
| evaluating energy availabilityenergy availability will be determined by measuring energy intake, exercise energy expenditure and fat-free mass and using the following formula: energy availability = (energy intake - exercise energy expenditure) / fat-free mass | Other | Female wheelchair athletes, Male wheelchair athletes |
Primary outcome
energy availability
Time frame: 7 consecutive days during pre-season
energy availability = (energy intake - exercise energy expenditure) / fat-free mass. Energy intake and exercise energy expenditure are measured using a food and training diary. The fat-free mass will be measured using a DXA scan.
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 31 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Energy Supply; Deficiency
RecruitingObservational study
Spinal Straightness, Posture And Balance, Physical Performance And Energy Consumption In Individuals With Stroke
Stroke, Postural; Defect
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.
Joelle Flueck, PhD principal investigator
Swiss Paraplegic Centre
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 Energy Supply; Deficiency, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 2 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 31 Mar 2020. 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 Switzerland. 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?
energy availability (time frame: 7 consecutive days during pre-season). 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 31 Mar 2020.