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Effect of Caffeine Supplementation and Personalized Insoles on Females

Primary Purpose

Caffeine, Fatigue, Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Caffeine supplementation
Personalized insoles
Control condition
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Caffeine focused on measuring women, insoles, kinematics, kinetics, performance, athletics, team sport

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad de ZaragozaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Personalized insoles

Caffeine supplementation

Control condition

Arm Description

Personalized insoles without supplementation

Standard insoles with caffeine supplementation (3mg/kg)

Standard insoles without supplementation

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2020
Last Updated
November 25, 2022
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04642131
Brief Title
Effect of Caffeine Supplementation and Personalized Insoles on Females
Official Title
The Effect of Fatigue, Caffeine Supplementation and Personalized Insoles on Biomechanics and Athletic Performance in Female Adult Soccer Players.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caffeine, Fatigue, Injuries, Females Xy, Soccer, Biomechanical Parameters
Keywords
women, insoles, kinematics, kinetics, performance, athletics, team sport

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates.
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized insoles
Arm Type
Experimental
Arm Description
Personalized insoles without supplementation
Arm Title
Caffeine supplementation
Arm Type
Experimental
Arm Description
Standard insoles with caffeine supplementation (3mg/kg)
Arm Title
Control condition
Arm Type
Placebo Comparator
Arm Description
Standard insoles without supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Caffeine supplementation
Intervention Description
Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.
Intervention Type
Device
Intervention Name(s)
Personalized insoles
Intervention Description
Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine
Intervention Type
Other
Intervention Name(s)
Control condition
Intervention Description
Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine
Primary Outcome Measure Information:
Title
Agility after fatigue and caffeine supplementation
Description
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Time Frame
One day
Title
Jump height after fatigue and caffeine supplementation
Description
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Time Frame
One day
Title
Repeated sprint ability after fatigue and caffeine supplementation
Description
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Time Frame
One day
Title
Agility after fatigue and personalized insoles
Description
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Time Frame
One day
Title
Jump height after fatigue and personalized insoles
Description
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Time Frame
One day
Title
Repeated sprint ability after fatigue and personalized insoles
Description
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Time Frame
One day
Title
Agility after fatigue and placebo
Description
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Time Frame
One day
Title
Jump height after fatigue and placebo
Description
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Time Frame
One day
Title
Repeated sprint ability after fatigue and placebo
Description
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Time Frame
One day
Title
Hip range of motion after fatigue and caffeine supplementation
Description
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.
Time Frame
During the intervention
Title
Knee range of motion after fatigue and caffeine supplementation
Description
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.
Time Frame
During the intervention
Title
Ankle range of motion after fatigue and caffeine supplementation
Description
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.
Time Frame
During the intervention
Title
Hip flexion moment after fatigue and caffeine supplementation
Description
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.
Time Frame
During the intervention
Title
Knee flexion moment after fatigue and caffeine supplementation
Description
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.
Time Frame
During the intervention
Title
Ankle flexion moment after fatigue and caffeine supplementation
Description
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.
Time Frame
During the intervention
Title
Hip range of motion after fatigue and personalized insoles
Description
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.
Time Frame
During the intervention
Title
Knee range of motion after fatigue and personalized insoles
Description
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.
Time Frame
During the intervention
Title
Ankle range of motion after fatigue and personalized insoles
Description
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.
Time Frame
During the intervention
Title
Hip flexion moment after fatigue and personalized insoles
Description
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.
Time Frame
During the intervention
Title
Knee flexion moment after fatigue and personalized insoles
Description
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.
Time Frame
During the intervention
Title
Ankle flexion moment after fatigue and personalized insoles
Description
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.
Time Frame
During the intervention
Title
Hip range of motion after fatigue and placebo
Description
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.
Time Frame
During the intervention
Title
Knee range of motion after fatigue and placebo
Description
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.
Time Frame
During the intervention
Title
Ankle range of motion after fatigue and placebo
Description
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.
Time Frame
During the intervention
Title
Hip flexion moment after fatigue and placebo
Description
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.
Time Frame
During the intervention
Title
Knee flexion moment after fatigue and placebo
Description
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.
Time Frame
During the intervention
Title
Ankle flexion moment after fatigue and placebo
Description
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.
Time Frame
During the intervention
Secondary Outcome Measure Information:
Title
Injury incidence
Description
Association between the primary outcomes and injury incidence registered through the International Federation of Association Football questionnaire (F-MARC)
Time Frame
Six months
Title
Sleep disturbances after caffeine ingestion
Description
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Time Frame
Immediately after the intervention
Title
Sleep disturbances after personalized insoles
Description
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Time Frame
Immediately after the intervention
Title
Sleep disturbances after placebo
Description
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Time Frame
Immediately after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Gómez Bruton, PhD
Phone
+34876553755
Email
bruton@unizar.es
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel Lozano Berges, PhD
Phone
+34876553755
Email
glozano@unizar.es
Facility Information:
Facility Name
Universidad de Zaragoza
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Lozano Berges, PhD
Email
glozano@unizar.es
First Name & Middle Initial & Last Name & Degree
Alejandro Gomez Bruton, PhD
Email
bruton@unizar.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Caffeine Supplementation and Personalized Insoles on Females

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