Effects of adding total motion release technique to caffeine ingestion on neuromuscular, cognitive and anaerobic performance in male sprinters: A randomized controlled trial
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 56 patients in 4 groups. Statistical software was used for randomization.
Settings and conduct
First, people were present at the Sports Medicine Federation and informed about the research process. Then they are randomly placed in a group. The first group (control), the second group (caffeine), the third group (TMR), the fourth group (caffeine tablets and TMR). Interventions are done for each person according to the group and then the evaluations are done again after 1 hour from the end of the first stage of evaluation. Participants were unaware of the study groups.
Participants/Inclusion and exclusion criteria
Semi-professional speed athletes, 18 to 40 years old, without specific sports complications and not sensitive to caffeine consumption.
Intervention groups
"First" (control), "second" (TMR), "third" (caffeine) and "fourth" (caffeine and TMR) are specified.
Main outcome variables
FMS test, Wingate anaerobic test, Stroop and Flanker cognitive tests
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230708058720N1
Registration date:2024-03-13, 1402/12/23
Registration timing:retrospective
Last update:2024-03-13, 1402/12/23
Update count:0
Registration date
2024-03-13, 1402/12/23
Registrant information
Name
Parsa Safapour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7407
Email address
p_safapour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
2023-07-04, 1402/04/13
Actual recruitment end date
2023-09-21, 1402/06/30
Trial completion date
2023-09-21, 1402/06/30
Scientific title
Effects of adding total motion release technique to caffeine ingestion on neuromuscular, cognitive and anaerobic performance in male sprinters
Public title
Investigating the effect of caffeine and warming up in sprinters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Semi-professional sprinter men aged 18-40
No history of musculoskeletal injury in the past 3 months
Not consuming caffeine, cigarettes and alcohol at least 48 hours before the research
No history of neurological disease or balance disorder
Absence of cardiovascular and metabolic problems
Exclusion criteria:
Allergy to caffeine
People's unwillingness to continue the research process
Nervous, kidney or stomach reflux problems
Incomplete range of motion in bilateral comparison
Age
From 18 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
The participants use the simple randomization technique with the Spin the wheel Picker decides software on mobile, which is available from Google Play with the link https://play.google.com/store/apps/details?id=com.randompicker.wheeldecides.randomnamepicker .spinthewheel was received, randomly placed into 4 groups. Allocation was determined through a random sequence. 4 indicators of 4 groups were entered in the software and the button was started when the person was present. Since the number of people in each group was considered to be 14 people, the chance of choosing people in the groups was the same. For each person, one of the numbers 1-4 was shown on the screen, which indicated the group and thus their type of intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
People were evaluated without a detailed explanation about the type of pill they were taking, and without contacting each other, and they did not know about other people's interventions.
Rest time of 40 or 60 minutes was applied according to grouping and individual people were evaluated.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
No. 24, Mostali Ave., N. Kargar, Enghelab Sq.
City
Tehran
Province
Tehran
Postal code
1418614914
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.TUMS.FNM.REC.1402.071
Health conditions studied
1
Description of health condition studied
Cognition, Functional Movement Screen, Total Motion Release, TMR, Wingate anaerobic
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional Movement Screen
Timepoint
Measuring functional movement screening score in the initial study and after taking the pill and performing the complete movement warm-up technique
Method of measurement
FMS toolkit
2
Description
Cognition Tests
Timepoint
Evaluation of cognitive functions by Eriksen Flanker and Stroop tests at the beginning of the study and after taking the pill and performing the complete movement warm-up technique
Method of measurement
Eriksen Flanker Task and Stroop test with laptop
3
Description
Wingate Anaerobic Test
Timepoint
Anaerobic test evaluation by Wingate test at the beginning of the study and after taking the pill and performing full movement warm-up technique
Method of measurement
Technogym Bike anaerobic test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: this group of participants at the beginning of the triple evaluation work (including two cognitive tests Stroop and Eriksen Flanker with a laptop in the offline version, a neuromuscular 7 movement test called FMS with the help of the Anham kit for this test, a Wingate's anaerobic test is performed with the help of Technogym's hand bike. Then according to the group in which they have been placed according to randomization (control), a tablet containing cellulose as a placebo and ineffective, manufactured by Karen Company, is consumed with a glass of water. Then, in the next step, they rest for 1 hour. In the next stage, all the evaluations of the first stage will be taken from the participants again.The duration of the meeting is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest, and the venue is at the Sports Medicine Federation.
Category
Rehabilitation
2
Description
Intervention group: This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the randomization group (caffeine), they consume a tablet containing 200 mg of caffeine, made by Karen company, with a glass of water. Then, in the next step, they rest for an hour so that the caffeine has its maximum effectiveness. After this break, all the evaluations of the first stage will be taken from the people again.The duration of the session is generally 1.5 hours, including two 15-minute evaluations and 1 hour of pill effect time, and the venue is at the Sports Medicine Federation.
Category
Rehabilitation
3
Description
Intervention group: This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the group they are placed in according to randomization (TMR), they consume a tablet containing cellulose, made by Karen company, which acts as an ineffective placebo, with a glass of water. Then, in the next step, they rest for 40 minutes. This time is due to the fact that the TMR warm-up process takes about 20 minutes and generally, similar to other groups, there is an interval of 1 hour between the two assessment stages. After this rest, subjects are asked to perform 6 TMR movements for each side for 2 sets of 15, with 30 seconds of rest between each set and 1 minute of rest between each movement. In the next stage, all the evaluations of the first stage will be taken from the participants again. The duration of the session is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest and exercise in between, and the venue is at the Sports Medicine Federation.
Category
Rehabilitation
4
Description
Intervention group: This group of participants performs triple evaluations at the beginning of the work (including two cognitive tests with a laptop, a neuromuscular 7 movement test called FMS, and a Wingate anaerobic test with the help of a hand bike). Then according to the randomization group (caffeine + TMR), a tablet containing 200 mg of caffeine, manufactured by Karen, is consumed with a glass of water. Then, in the next step, they rest for 40 minutes. This time is due to the fact that the TMR warm-up process takes about 20 minutes and generally, similar to other groups, there is an interval of 1 hour between the two assessment stages. After this rest, subjects are asked to perform 6 TMR movements for each side for 2 sets of 15, with 30 seconds of rest between each set and 1 minute of rest between each movement. In the next stage, all the evaluations of the first stage will be taken from the participants again.The duration of the meeting is generally 1.5 hours, including two 15-minute evaluations and 1 hour of rest for the effectiveness of the pill and exercise, and the venue is at the Sports Medicine Federation.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine Federation of IR of Iran
Full name of responsible person
Physical Therapist Dr. Morteza Ahmadi
Street address
Tehran Province, Tehran, District 7, Varzandeh St, PC5H+R6P
City
Tehran
Province
Tehran
Postal code
۱۵۷۱۷۴۵۶۱۳
Phone
+98 21 83826
Fax
+98 21 8883 3498
Email
p_safapour@razi.tums.ac.ir
Web page address
https://www.ifsm.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Sari
Street address
No. 24, Mostali Ave., N. Kargar St., Enghelab Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1418814371
Phone
+98 21 6693 7407
Email
p_safapour@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parsa Safapour
Position
Master's Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 24, Mostali Ave., N. Kargar St., Enghelab Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1418814371
Phone
+98 21 6693 7407
Email
p_safapour@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parsa Safapour
Position
Master's Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 24, Mostali Ave., N. Kargar St., Enghelab Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1418814371
Phone
+98 21 6693 7407
Email
p_safapour@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parsa Safapour
Position
Master's Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 24, Mostali Ave., N. Kargar St., Enghelab Sq., Tehran
City
Tehran
Province
Tehran
Postal code
1418814371
Phone
+98 21 6693 7407
Email
p_safapour@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data of this study will be placed in the form of 56 separate participants, each of which has 28 variables. 14 cases of interventions are related to the first stage of evaluation and 14 cases are related to the second stage of evaluation.
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
Those interested in the field of physiotherapy and sports and sports nutrition, other enthusiastic researchers
Under which criteria data/document could be used
The use of data is unimpeded by mentioning the source
From where data/document is obtainable
Email below
p_safapour@razi.tums.ac.ir
What processes are involved for a request to access data/document