Performance Assessement for Paralympic Athletes

Paralympic Athletes Clinical Trial

— PARAPERF  

Official title:

Evaluation of Performance in Paralympic Athletes: Performance Outcomes in Sports

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748497
• Other study ID #: APHP201139
• Secondary ID: 2020-A02919-30
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: June 2024

Study information

• Verified date: March 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean François Toussaint, MD, PhD
• Phone: +33 (0)1 42 34 82 10
• Email: jean-francois.toussaint[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Paralympic Athletes
• Sportive Performance

Intervention

Other:
• Standardization of evaluation and follow-up
Standardization of evaluation and clinical and sportive follow-up of athletes. Made-to-measure technical supports will be tested regarding the Paralympic regulations.

Locations

Country	Name	City	State
France	Service Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic sportive activity	Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.	through study completion, an average of 1 year
Primary	Dynamic sportive activity	Dynamic sportive activity: Sprint Capacity Test will be used to have maximal speed.	at 42 months
Primary	Static sportive activity	Static sportive activity: maximal speed of movement of pression center.	through study completion, an average of 1 year
Primary	Static sportive activity	Static sportive activity: maximal speed of movement of pression center.	at 42 months
Secondary	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.	through study completion, an average of 1 year
Secondary	Biomechanical indices of performance: arms and shoulder's Strength	Arms and shoulder's Strength will be measured by force platform.	through study completion, an average of 1 year
Secondary	Physiological indices of performance: maximal aerobic speed (MAS)	Maximal aerobic speed (MAS) will be measured by Repetition Per Minute on a Arm ergometer.	Twice through study completion, an average of 42 months
Secondary	Physiological indices of performance: maximal aerobic power	Maximal aerobic power will be measured by following Watts fluctuation during the incremental hand-biking test.	Twice through study completion, an average of 42 months
Secondary	Fatigue assessment	Fatigue assessment will be measured by Fatigue Index (Power max ratio).	Twice through study completion, an average of 42 months
Secondary	Blood lactate concentration	Blood lactatemia level will be measured by lactometer.	immediately after the intervention
Secondary	VO2 peak oxygen uptake	VO2 peak oxygen uptake	through study completion, an average of 1 year
Secondary	Peak breath expiration volume assessment	VE peak: peak breath expiration volume	through study completion, an average of 1 year
Secondary	Peak cardiac frequence	CF: peak cardiac frequence	through study completion, an average of 1 year
Secondary	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").	through study completion, an average of 1 year
Secondary	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).	through study completion, an average of 1 year
Secondary	Mechanical indices of wheelchair propulsion - applied forces on handrim during the propulsion	Applied forces on handrim during the propulsion: measured by force platform.	through study completion, an average of 1 year
Secondary	Acceleration profil during the propulsion		through study completion, an average of 1 year
Secondary	Speed profil during the propulsion		through study completion, an average of 1 year