The effect of fatigue on postural control and cognitive performance
| ISRCTN | ISRCTN18115608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18115608 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | H1402563451425 |
| Sponsor | Universitat de València |
| Funder | Investigator initiated and funded |
- Submission date
- 05/08/2025
- Registration date
- 05/08/2025
- Last edited
- 05/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The ability to maintain attention and react quickly is essential for military personnel, especially after physical exertion. This study aims to investigate whether the level of cardiorespiratory fitness (CRF) affects changes in vigilance and reaction time after intense physical exercise in trained soldiers.
Who can participate?
Healthy male soldiers aged 25–40 years, with normal or corrected vision, who had passed the Annual Military Physical Fitness Test, and had no neurological, sensory, postural or gait disorders.
What does the study involve?
Participants performed a computer-based attention test (go/no-go Psychomotor Vigilance Task) before and immediately after a maximal incremental treadmill running test to exhaustion. Reaction time, commission errors, and omission errors were recorded. The treadmill test followed the Bruce protocol with continuous gas exchange measurement. Based on VO₂max results, participants were classified into high or low CRF groups.
What are the possible benefits and risks of participating?
This research can help improve training strategies to optimise cognitive performance after physical exertion in military and similar professions. Risks are minimal but may include temporary fatigue, dizziness, or mild gastrointestinal discomfort, which typically resolve within 12 hours.
Where is the study run from?
The Exercise Physiology Laboratory, Faculty of Physical Activity and Sport Sciences, University of Valencia (Spain)
When is the study starting and how long is it expected to run for?
September 2014 to June 2015
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Jose Luis Bermejo Ruiz, j.luis.bermejo@uv.es
Contact information
Public, Scientific, Principal investigator
University of Valencia
Faculty of Physical Activity and Sport Sciences
C/ Gascó Oliag, 3
Valencia
46010
Spain
 ORCID ID |
0000-0002-1550-0564 |
|---|---|
| Phone | +34 (0)686225802 |
| j.luis.bermejo@uv.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomized controlled within-subject design |
| Secondary study design | Non randomised study |
| Participant information sheet | 47782_PIS.pdf |
| Scientific title | Cardiorespiratory fitness modulates the effect of acute exercise on vigilance performance in trained soldiers |
| Study acronym | CRF-Cognition |
| Study objectives | Primary objective: To determine whether cardiorespiratory fitness level modulates the effect of acute maximal exercise on vigilance performance in trained soldiers. Secondary objectives: 1. To compare changes in reaction time, commission errors, and omission errors before and after maximal exercise between high- and low-fitness groups. 2. To analyse whether the magnitude of improvement in vigilance differs according to baseline fitness level. Study hypothesis: Acute maximal exercise will improve vigilance performance in trained soldiers, and the magnitude of improvement will differ depending on cardiorespiratory fitness level. |
| Ethics approval(s) |
Approved 25/07/2014, Ethics Committee of the University of Valencia (Av. Blasco Ibáñez, 13, Valencia, 46010, Spain; +34 (0)96 16 25 834; ceih@uv.es), ref: H1402563451425 |
| Health condition(s) or problem(s) studied | Cognitive performance, vigilance, and reaction time in healthy trained soldiers under acute physical fatigue |
| Intervention | Participants completed a maximal incremental treadmill running protocol to exhaustion, followed by immediate post-exercise assessment of vigilance performance using a go/no-go psychomotor vigilance task (PVT). The same task was performed before exercise as baseline. Participants were classified into high- or low-cardiorespiratory fitness groups according to ACSM guidelines. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | Reaction time (milliseconds) is measured using a computer-based go/no-go Psychomotor Vigilance Task (PVT) at baseline (pre-exercise) and immediately after completion of the maximal incremental treadmill test (post-exercise) |
| Key secondary outcome measure(s) | 1. Commission errors (%) are measured using the same go/no-go PVT at baseline and immediately post-exercise 2. Omission errors (%) are measured using the same go/no-go PVT at baseline and immediately post-exercise |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 40 Years |
| Sex | Male |
| Target sample size at registration | 34 |
| Total final enrolment | 34 |
| Key inclusion criteria | 1. Male soldiers aged 25–40 years 2. Passed Annual Military Physical Fitness Test (AMPFT) 3. Normal or corrected-to-normal vision 4. No neurological, sensory, postural, or gait disorders 5. No history of neuropsychological impairment |
| Key exclusion criteria | 1. Cardiovascular disease or other contraindications to maximal exercise 2. Recent musculoskeletal injury 3. Consumption of stimulants or alcohol within 24 hours prior to testing |
| Date of first enrolment | 01/09/2014 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
C/ Gascó Oliag, 3
Valencia
46010
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not publicly available due to participant confidentiality but are available from the corresponding author on reasonable request. All shared data will be fully anonymised, and requests will be considered for research purposes only, subject to approval by the research team and in compliance with institutional and ethical guidelines. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 05/08/2025 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 05/08/2025 | No | No |
Additional files
Editorial Notes
05/08/2025: Study's existence confirmed by the Ethics Committee of the University of Valencia.
