Effect of Caffeine Supplementation and Personalized Insoles on Females

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

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04642131

Enrollment

Registered

2020-11-24

Start date

2020-12-09

Completion date

2025-12-31

Last updated

2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

women, insoles, kinematics, kinetics, performance, athletics, team sport

Brief 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.

Interventions

DIETARY_SUPPLEMENTCaffeine supplementation

Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.

DEVICEPersonalized insoles

Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine

OTHERControl condition

Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Masking description

Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates.

Intervention 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.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Ankle flexion moment after fatigue and placebo	During the intervention	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.
Knee range of motion after fatigue and placebo	During the intervention	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.
Ankle range of motion after fatigue and placebo	During the intervention	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.
Hip flexion moment after fatigue and placebo	During the intervention	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.
Knee flexion moment after fatigue and placebo	During the intervention	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.
Agility after fatigue and caffeine supplementation	One day	Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Jump height after fatigue and caffeine supplementation	One day	Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Repeated sprint ability after fatigue and caffeine supplementation	One day	Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Agility after fatigue and personalized insoles	One day	Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Jump height after fatigue and personalized insoles	One day	Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Repeated sprint ability after fatigue and personalized insoles	One day	Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Agility after fatigue and placebo	One day	Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Jump height after fatigue and placebo	One day	Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Repeated sprint ability after fatigue and placebo	One day	Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Hip range of motion after fatigue and caffeine supplementation	During the intervention	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.
Knee range of motion after fatigue and caffeine supplementation	During the intervention	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.
Ankle range of motion after fatigue and caffeine supplementation	During the intervention	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.
Hip flexion moment after fatigue and caffeine supplementation	During the intervention	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.
Knee flexion moment after fatigue and caffeine supplementation	During the intervention	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.
Ankle flexion moment after fatigue and caffeine supplementation	During the intervention	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.
Hip range of motion after fatigue and personalized insoles	During the intervention	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.
Knee range of motion after fatigue and personalized insoles	During the intervention	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.
Ankle range of motion after fatigue and personalized insoles	During the intervention	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.
Hip flexion moment after fatigue and personalized insoles	During the intervention	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.
Knee flexion moment after fatigue and personalized insoles	During the intervention	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.
Ankle flexion moment after fatigue and personalized insoles	During the intervention	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.
Hip range of motion after fatigue and placebo	During the intervention	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.

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026