Effect of Caffeine Supplementation and Personalized Insoles on Females

NCT04642131 | Suspended

• 1 other identifier: UZCUD2020-BIO-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (27)

• 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 Outcomes (4)

• Injury incidence

  Six months

• Sleep disturbances after caffeine ingestion

  Immediately after the intervention

• Sleep disturbances after personalized insoles

  Immediately after the intervention

• Sleep disturbances after placebo

  Immediately after the intervention

Study Arms (3)

Personalized insoles

EXPERIMENTAL

Personalized insoles without supplementation

Device: Personalized insoles

Caffeine supplementation

EXPERIMENTAL

Standard insoles with caffeine supplementation (3mg/kg)

Dietary Supplement: Caffeine supplementation

Control condition

PLACEBO COMPARATOR

Standard insoles without supplementation

Other: Control condition

Interventions

Caffeine supplementation DIETARY_SUPPLEMENT

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

Caffeine supplementation

Personalized insoles DEVICE

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

Personalized insoles

Control condition OTHER

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

Control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• Soccer players who have been competing for at least 3 years

You may not qualify if:

• Participants with major injuries in the lower limbs within the 12 months before testing.
• Participants consuming ephedrine or related medicines

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, 50012, Spain

Location

MeSH Terms

Conditions

Fatigue; Wounds and Injuries; Disorder of Sex Development, 46,XY

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 24, 2020
• Study Start: December 9, 2020
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

ES (1)