Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609803929557 Date of Registration: 07/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Half time cooling on Fatigue Etiology and Performance in the heat
Official scientific title Effect of Half time cooling on Fatigue Etiology and Performance in the heat
Brief summary describing the background and objectives of the trial Athlete performance during intermittent, high-intensity efforts (e.g., simulated soccer matches) is often limited by neuromuscular fatigue, heat stress, and suboptimal recovery strategies. Various acute interventions have been proposed to mitigate these limitations. Cooling interventions can attenuate thermal strain. However, the effectiveness of this approach in a sport-specific context remains insufficiently explored. - This trial aimed to investigate and compare the effectiveness of neck cooling: To assess whether an external cooling method (ice towel application) during breaks attenuate thermal stress and sustain performance by attenuate neuromuscular fatigue during the Loughborough Intermittent Shuttle Test (LIST)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 15/06/2022
Actual trial start date 18/07/2022
Anticipated date of last follow up 31/07/2022
Actual Last follow-up date 30/08/2022
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 14
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neck cooling PC Standardized 100% cotton towels (100 × 50 cm) were maintained at 4–5 °C for PC 15-min half-time interval Standardized 100% cotton towels (100 × 50 cm) were maintained at 4–5 °C for with temperature verified using a digital thermometer at each exchange. Towels were wrapped over the posterior and lateral neck and replaced every 3 min during the 15-min half-time interval, resulting in five applications 14
Control Group Control group CON Standardized 100% cotton towels (100 × 50 cm) were maintained at 20–30 °C for CON. 15-min half-time interval Standardized 100% cotton towels (100 × 50 cm) were maintained at 20–30 °C for CON, with temperature verified using a digital thermometer at each exchange. Towels were wrapped over the posterior and lateral neck and replaced every 3 min during the 15-min half-time interval, resulting in five applications 14 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male soccer players aged 18–30 years. Currently training and competing at university, semi-professional, or club level. Engaged in regular training (≥3 sessions per week) for the past 6 months. Free from musculoskeletal injuries in the past 3 months. History of cardiovascular, metabolic, neurological, or renal disease. Current use of medications (including analgesics, anti-inflammatories, or supplements) that may interfere with performance or recovery. Known allergy or contraindication to acetaminophen. Current smoker or history of smoking within the last year. Participation in another clinical trial within the past 3 months. Inability to comply with study procedures or testing schedule. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2020 the committee of human protection C.P.SUD
Ethics Committee Address
Street address City Postal code Country
Airport Road Sfax Sfax 2100 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of Neuromuscular Function of the Quadriceps: EMG activity was recorded from the rectus femoris (RF), vastus lateralis (VL), and vastus medialis (VM). The cathode (self-adhesive electrode: Ag-AgCl, 10-mm diameter) was positioned firmly on the femoral triangle. The anode, a 10 × 5 cm self-adhesive stimulation electrode (Compex Medical SA, Ecublens, Switzerland) was placed midway between the greater trochanter and the iliac crest. Optimal stimulation intensity was determined from M-wave and force measurements before each testing session. The stimulation intensity was increased by 5 mA until there was no further increase in peak twitch force (i.e., plateau in knee extensor twitch force) and concomitant peak-to-peak maximal M-wave amplitude (M-max). During the subsequent testing procedures, the intensity was set to 150% of this intensity (supramaximal intensity) to avoid the potential confounding effect of axonal hyperpolarization (Burke, 2002). The neuromuscular assessment began with two practices of MVIC to ensure potentiation of subsequent evoked measures, followed by three ~3 s MVICs, all separated by 30 s. For each MVIC, two electrical nerve stimulations were delivered over the femoral nerve. The first stimulation, delivered during the MVIC, was named the superimposed twitch, and the second stimulation, delivered 3 s after the MVIC, was named the potentiated twitch (Qtw,pot). For central fatigue, we calculated changes in voluntary activation (VA) using both superimposed and potentiated twitches amplitude as follows (Daab et al., 2024): VA (%) = [1 − Superimposed twitch/Qtw,pot] × 100. Twenty-meter sprint times (SP) during the LIST were measured using telemetric photoelectric cells placed at 1 and 20 m. and Mean skin temperature, baseline, half time HT, full time FT
Secondary Outcome heart rate, thermal sensation , thermal comfort using and rating of perceived exertion . baseline and evry 15 min
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Higher Institute of Sport and Physical Education of Sfax Airport Road, Km 3,5, BP 384, Sfax - 3000 Tunisia Sfax 2100 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wael Daab Gafsa airport road Sfax 2100 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NA NA Gafsa 2101 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wael Daab daab_w@yahoo.fr +21620612799 Airport Road
City Postal code Country Position/Affiliation
Gafsa Tunisia Assistant Professor University of Sfax
Role Name Email Phone Street address
Public Enquiries Mohamed Amine Bouzid mohamedaminbouzid@hotmail.fr +21625678987 Road sfax Tunisia
City Postal code Country Position/Affiliation
Sfax Tunisia Associate Professor University of Sfax
Role Name Email Phone Street address
Scientific Enquiries Haithem Rebai haithem.rebai@yahoo.fr +21697546789 Road Sokra Sfax
City Postal code Country Position/Affiliation
Sfax Tunisia Associate Professor Issep Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data (IPD) collected during this study will be shared in a de-identified format with qualified researchers and organizations upon request. The data will include all de-identified raw data, excluding any information that could directly identify the participants. The data will be available for sharing no later than 2 years following article publication of the study results. Requests for access to the data should be submitted to Dr. Wael Daab . Data sharing will be conducted in compliance with applicable data protection regulations and ethical guidelines. Statistical Analysis Plan,Study Protocol Data will be available beginning 6 months and ending 2 years following article publication Data will be available to researchers who provide a methodologically sound proposal, to achieve the aims stated in the proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 29/08/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 29/08/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information