Effect of Caffeine Supplementation and Personalized Insoles on Females

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04642131
• Other study ID #: UZCUD2020-BIO-02
• Status: Suspended
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 16
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biomechanical Parameters
• Caffeine
• Fatigue
• Females Xy
• Injuries
• Soccer

Intervention

Dietary Supplement:
• Caffeine supplementation
Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.

Device:
• Personalized insoles
Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine

Other:
• Control condition
Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine

Locations

Country	Name	City	State
Spain	Universidad de Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

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