Paralympic AthletesPARAPERFNCT04748497
Performance Assessement for Paralympic Athletes
A study testing Standardization of evaluation and follow-up in people with Paralympic Athletes and Sportive Performance, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes. The secondary objectives of the study: quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Paralympic Athletes, Sportive Performance
- What is being tested?
- Standardization of evaluation and follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2021to Jun 2024
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- High-lever paralympic athletes registered on the ministerial list or selected by Parasport Federation of France or Shooting Federation of France;
- Aged >= 14 years;
- Informed consent signed by adult athlete or by holder of parental authority or guardian for minor athlete;
- Covered by social security system.
Who cannot join
- Temporary or definitive contraindication to the practice of the affected sport activity;
- Undergoing anti-coagulated treatments;
- Cognitive disabilities conducting impossibility to participating to clinical trial, such as serious cognitive troubles, behaviors troubles, psychic troubles or upgraded curatorship needing;
- Under guardianship or judicial decision;
- Ongoing pregnancy.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
Garches, 92380
About this study
Official title: Evaluation of Performance in Paralympic Athletes: Performance Outcomes in Sports
The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes.
The secondary objectives of the study:
- quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive competitions;
- quantification and performances monitoring of physiological performances during the filed tests, the laboratory analysis and the sportive competitions;
- quantification and risk monitoring of discipline-relative musculo-squeletic troubles, caused by training or using of sportive equipment;
- quantification and mechanical monitoring by the made-to-measure or usual sportive material.
Read the detailed description
The sportive performance results from a range of determinations such as: physiological, biomechanical, morphological, psychological, social and environmental factors. The interactions between athletes, equipment, training and environment influences the development of athletes' performance. In the context of the coming Paris 2024 Paralympic Games, the performance construction for the exploration, the quantification and the management of all factors is an commun objective between sportive team, medical team and researchers.
- Conditions
- Paralympic Athletes, Sportive Performance
- Being tested
- Standardization of evaluation and follow-up
- Keywords
- paralympic athletes, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardization of evaluation and follow-upOther
Standardization of evaluation and clinical and sportive follow-up of athletes.
Made-to-measure technical supports will be tested regarding the Paralympic regulations.
| Study group | Role | What they receive |
|---|---|---|
| Parasportives of various disciplines | Other | Not described Receives: Other: Standardization of evaluation and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic sportive activity
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
Measured: through study completion, an average of 1 year
Dynamic sportive activity
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
Measured: at 42 months
Static sportive activity
Static sportive activity: maximal speed of movement of pression center.
Measured: through study completion, an average of 1 year
Static sportive activity
Static sportive activity: maximal speed of movement of pression center.
Measured: at 42 months
Secondary outcomes (14)
Biomechanical indices of performance: isometric power measurement
Isometric power will be measured by MicroFet \& handgrip of 26 measures, advice for healthcare professionals to measure handgrip strength forces to test and document grip deficits and to evaluate consistency of effort.
Measured: through study completion, an average of 1 year
Biomechanical indices of performance: arms and shoulder's Strength
Arms and shoulder's Strength will be measured by force platform.
Measured: through study completion, an average of 1 year
Physiological indices of performance: maximal aerobic speed (MAS)
Maximal aerobic speed (MAS) will be measured by Repetition Per Minute on a Arm ergometer.
Measured: Twice through study completion, an average of 42 months
Physiological indices of performance: maximal aerobic power
Maximal aerobic power will be measured by following Watts fluctuation during the incremental hand-biking test.
Measured: Twice through study completion, an average of 42 months
Fatigue assessment
Fatigue assessment will be measured by Fatigue Index (Power max ratio).
Measured: Twice through study completion, an average of 42 months
Blood lactate concentration
Blood lactatemia level will be measured by lactometer.
Measured: immediately after the intervention
VO2 peak oxygen uptake
VO2 peak oxygen uptake
Measured: through study completion, an average of 1 year
Peak breath expiration volume assessment
VE peak: peak breath expiration volume
Measured: through study completion, an average of 1 year
Peak cardiac frequence
CF: peak cardiac frequence
Measured: through study completion, an average of 1 year
Musculo-squeletic troubles risks measurement
Musculo-squeletic troubles risks will be measured by medical following and clinical method of functional assessment of the shoulder (i.e. "Constant scale").
Measured: through study completion, an average of 1 year
Time and distance of deceleration of wheelchair during riding test
Time and distance of deceleration of wheelchair during riding test: measured by signal analysis of instrumented wheelchair (inertial control units).
Measured: through study completion, an average of 1 year
Mechanical indices of wheelchair propulsion - applied forces on handrim during the propulsion
Applied forces on handrim during the propulsion: measured by force platform.
Measured: through study completion, an average of 1 year
Acceleration profil during the propulsion
Measured: through study completion, an average of 1 year
Speed profil during the propulsion
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start8 Jan 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralympic AthletesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Genêt, MD, PhD, Principal investigator, Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHPJean François Toussaint, MD, PhD, Study director, Centre d'Investigation en Médecine du Sport, Hôpital Hôtel Dieu, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748497
- Sponsor's protocol ID
- APHP201139
- Other IDs
- 2020-A02919-30
- Acronym
- PARAPERF
- Status last verified
- Mar 2022
- First submitted
- 11 Dec 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance in Paralympic Athletes: Performance Outcomes in Sports
- ClinicalTrials.gov ID
- NCT04748497
- Acronym / sponsor ID
- PARAPERF / APHP201139
- Conditions
- Paralympic Athletes, Sportive Performance
- Keywords
- paralympic athletes, performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Feb 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.
The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes.
The secondary objectives of the study:
- quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive competitions;
- quantification and performances monitoring of physiological performances during the filed tests, the laboratory analysis and the sportive competitions;
- quantification and risk monitoring of discipline-relative musculo-squeletic troubles, caused by training or using of sportive equipment;
- quantification and mechanical monitoring by the made-to-measure or usual sportive material.
Detailed description
The sportive performance results from a range of determinations such as: physiological, biomechanical, morphological, psychological, social and environmental factors. The interactions between athletes, equipment, training and environment influences the development of athletes' performance. In the context of the coming Paris 2024 Paralympic Games, the performance construction for the exploration, the quantification and the management of all factors is an commun objective between sportive team, medical team and researchers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parasportives of various disciplines | Other | Other: Standardization of evaluation and follow-up |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- High-lever paralympic athletes registered on the ministerial list or selected by Parasport Federation of France or Shooting Federation of France;
- Aged >= 14 years;
- Informed consent signed by adult athlete or by holder of parental authority or guardian for minor athlete;
- Covered by social security system.
Key exclusion criteria (5 listed)
- Temporary or definitive contraindication to the practice of the affected sport activity;
- Undergoing anti-coagulated treatments;
- Cognitive disabilities conducting impossibility to participating to clinical trial, such as serious cognitive troubles, behaviors troubles, psychic troubles or upgraded curatorship needing;
- Under guardianship or judicial decision;
- Ongoing pregnancy.
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 |
|---|---|---|
| Standardization of evaluation and follow-upStandardization of evaluation and clinical and sportive follow-up of athletes. Made-to-measure technical supports will be tested regarding the Paralympic regulations. | Other | Parasportives of various disciplines |
Primary outcome
Dynamic sportive activity
Time frame: through study completion, an average of 1 year
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
Dynamic sportive activity
Time frame: at 42 months
Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.
Static sportive activity
Time frame: through study completion, an average of 1 year
Static sportive activity: maximal speed of movement of pression center.
Static sportive activity
Time frame: at 42 months
Static sportive activity: maximal speed of movement of pression center.
14 secondary outcomes
Biomechanical indices of performance: isometric power measurement
Time frame: through study completion, an average of 1 year
Biomechanical indices of performance: arms and shoulder's Strength
Time frame: through study completion, an average of 1 year
Physiological indices of performance: maximal aerobic speed (MAS)
Time frame: Twice through study completion, an average of 42 months
Physiological indices of performance: maximal aerobic power
Time frame: Twice through study completion, an average of 42 months
Fatigue assessment
Time frame: Twice through study completion, an average of 42 months
Blood lactate concentration
Time frame: immediately after the intervention
VO2 peak oxygen uptake
Time frame: through study completion, an average of 1 year
Peak breath expiration volume assessment
Time frame: through study completion, an average of 1 year
Peak cardiac frequence
Time frame: through study completion, an average of 1 year
Musculo-squeletic troubles risks measurement
Time frame: through study completion, an average of 1 year
Time and distance of deceleration of wheelchair during riding test
Time frame: through study completion, an average of 1 year
Mechanical indices of wheelchair propulsion - applied forces on handrim during the propulsion
Time frame: through study completion, an average of 1 year
Acceleration profil during the propulsion
Time frame: through study completion, an average of 1 year
Speed profil during the propulsion
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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.
François Genêt, MD, PhD principal investigator
Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
Jean François Toussaint, MD, PhD study director
Centre d'Investigation en Médecine du Sport, Hôpital Hôtel Dieu, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardization of evaluation and follow-up in people with Paralympic Athletes and Sportive Performance, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean François Toussaint, MD, PhD (+33 (0)1 42 34 82 10, jean-francois.toussaint@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic sportive activity (time frame: through study completion, an average of 1 year). The study lists 4 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 Mar 2022.