Effect of Caffeine Supplementation and Personalized Insoles on Females

Study Overview
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Brief Summary
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Several studies have shown the positive effect that caffeine has on athletic performance related variables. Nonetheless, most studies have been developed in males and have not studied the possible effects on biomechanics and related injuries. Moreover, the inclusion of personalized insoles could also affect biomechanical patterns and thus injury incidence that has shown to be higher when athletes are fatigued. Therefore, the aim of the present randomized controlled trial is to evaluate the effect of fatigue, caffeine supplementation and personalized insoles on biomechanics and athletic performance in female adult soccer players.

Official Title
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The Effect of Fatigue, Caffeine Supplementation and Personalized Insoles on Biomechanics and Athletic Performance in Female Adult Soccer Players.

Conditions
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Caffeine, Fatigue, Injuries, Females Xy, Soccer, Biomechanical Parameters

Intervention / Treatment
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* Dietary Supplement: Caffeine supplementation
* Device: Personalized insoles
* Other: Control condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females Soccer players who have been competing for at least 3 years Exclusion Criteria: Participants with major injuries in the lower limbs within the 12 months before testing. Participants consuming ephedrine or related medicines

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates, and personalized insoles or standard insoles. All participants will complete athletic and biomechanics tests before and after completing a 43 minute fatigue protocol.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized insoles<br>Personalized insoles without supplementation | Device: Personalized insoles<br>* Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine<br>|
| Experimental: Caffeine supplementation<br>Standard insoles with caffeine supplementation (3mg/kg) | Dietary Supplement: Caffeine supplementation<br>* Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.<br>|
| Placebo Comparator: Control condition<br>Standard insoles without supplementation | Other: Control condition<br>* Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agility after fatigue and caffeine supplementation | Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells. | One day | 
| Jump height after fatigue and caffeine supplementation | Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates. | One day | 
| Repeated sprint ability after fatigue and caffeine supplementation | Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells. | One day | 
| Agility after fatigue and personalized insoles | Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells. | One day | 
| Jump height after fatigue and personalized insoles | Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates. | One day | 
| Repeated sprint ability after fatigue and personalized insoles | Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells. | One day | 
| Agility after fatigue and placebo | Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells. | One day | 
| Jump height after fatigue and placebo | Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates. | One day | 
| Repeated sprint ability after fatigue and placebo | Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells. | One day | 
| Hip range of motion after fatigue and caffeine supplementation | Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Knee range of motion after fatigue and caffeine supplementation | Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Ankle range of motion after fatigue and caffeine supplementation | Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Hip flexion moment after fatigue and caffeine supplementation | Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Knee flexion moment after fatigue and caffeine supplementation | Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Ankle flexion moment after fatigue and caffeine supplementation | Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Hip range of motion after fatigue and personalized insoles | Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Knee range of motion after fatigue and personalized insoles | Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Ankle range of motion after fatigue and personalized insoles | Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Hip flexion moment after fatigue and personalized insoles | Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Knee flexion moment after fatigue and personalized insoles | Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Ankle flexion moment after fatigue and personalized insoles | Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Hip range of motion after fatigue and placebo | Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Knee range of motion after fatigue and placebo | Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Ankle range of motion after fatigue and placebo | Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Hip flexion moment after fatigue and placebo | Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Knee flexion moment after fatigue and placebo | Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 
| Ankle flexion moment after fatigue and placebo | Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system. | During the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury incidence | Association between the primary outcomes and injury incidence registered through the International Federation of Association Football questionnaire (F-MARC) | Six months | 
| Sleep disturbances after caffeine ingestion | Rate of patients with sleep problems assessed with the Athens sleep questionnaire | Immediately after the intervention | 
| Sleep disturbances after personalized insoles | Rate of patients with sleep problems assessed with the Athens sleep questionnaire | Immediately after the intervention | 
| Sleep disturbances after placebo | Rate of patients with sleep problems assessed with the Athens sleep questionnaire | Immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women, insoles, kinematics, kinetics, performance, athletics, team sport