Healthy VolunteerNCT07026383
Physiological and Psychological Profiles
An observational study of Healthy Volunteer and Female, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
Trial summary
The participation of women in high-impact sports such as rugby and basketball has been steadily increasing in Saudi Arabia. These sports are known for their physical demands and competitive nature, which have heightened the incidence of sports-related injuries. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Female
- What is being tested?
- performance test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 25 Jan 2025to 20 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study participants will be selected from female athletes aged 18 to 35 years who are actively participating in rugby and basketball teams in Saudi Arabia. These athletes are involved in regular training and competitive matches, have at least one year of experience in their respective sports, and represent the population of active female sports enthusiasts within this age group in the region.
Who may be able to join
- Female athletes aged 18-35 years recruited from rugby and basketball teams in Saudi Arabia
- Actively involved in rugby and basketball
- Minimum of one year of experience in their respective sport
- Regular participation in training and competitive events
Who cannot join
- Recent injury within the last six months that limits athletic performance Pregnancy
- Presence of any chronic medical condition that could influence study outcomes
- Uncontrolled diabetes or hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological and Psychological Profiles of the Athletic Women and the Risk of Sport Injuries in Saudi Arabia
The participation of women in high-impact sports such as rugby and basketball has been steadily increasing in Saudi Arabia. These sports are known for their physical demands and competitive nature, which have heightened the incidence of sports-related injuries. Understanding the predictive factors for these injuries is critical for developing preventive strategies, reducing long-term health consequences, and reducing healthcare burdens. Therefore, this study aims to identify the predictive effect of physiological factors (e.g., muscle strength, anaerobic power, oxygen consumption) and psychological factors (e.g., self-efficacy, resilience) on sports injuries among female athletes in Saudi Arabia, particularly focusing on those involved in rugby and basketball.
A prospective cross-sectional design will be employed, involving a total of 30 female athletes aged 18-35 years actively participating in rugby and basketball. Data will be collected at the lifestyle research center through a series of physiological assessments, including maximal oxygen consumption, anaerobic power testing, isokinetic muscle strength testing, and psychological evaluations using validated questionnaires. The findings are expected to provide insights into the specific factors that increase injury risk among Saudi female athletes, offering targeted strategies for injury prevention. These strategies aim not only to minimize injuries but also to reduce associated healthcare costs, thereby supporting the sustainable growth of women's sports in Saudi Arabia. Ultimately, this study seeks to contribute to the broader objectives of Vision 2030 by promoting a vibrant sports culture and enhancing public health.
- Conditions
- Healthy Volunteer, Female
- Being tested
- performance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performance testBehavioural
Injury risk was evaluated using the Lower Extremity Functional Test (LEFT), which involves eight agility drills performed consecutively on a diamond-shaped course without rest intervals. The test includes eight components-forward run, backward run, side shuffle, carioca, figure-eight run, 45-degree cuts, 90-degree cuts, and a counter vertical jump-along with the single-leg hop for distance, following a standardized testing protocol known to predict injury risk. Participants who took longer to complete the test were categorized into the high injury risk group, while those with shorter completion times were classified into the low injury risk group.
| Study group | Role | What they receive |
|---|---|---|
| athletic | Not described Receives: Behavioral: performance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption test:
subjects will complete symptom limited treadmill exercise tests using a modification of Balkes protocol, which has been previously used among individuals with obesity. Participants will be connected to a gas analyzing metabolic cart (mouthpiece) for the determination of oxygen uptake, ventilated carbon dioxide, lung volumes, and heart rate through a gas analysis system using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) and HR monitor (Polar H7, Kempele, Finland).The tests will be performed on a computerized treadmill allowing programmed adjustment of both speed and inclination components of the work rate. The gas exchange system measured the oxygen consumption (VO2) and carbon dioxide production (VCO2) throughout the test.
Measured: baseline
Wingate test
The Wingate test will be performed on a cycle ergometer (Ergomedic 828E, Monark, Sweden). Participants will perform a 30-second all-out sprint against a resistance equivalent to 7.5% of their body weight. The test measures the peak power (in watts), average power, and rate of fatigue. These metrics provide insights into the anaerobic performance capabilities of athletes.
Measured: baseline
Isokinetic muscle strength
testing will be conducted using an isokinetic dynamometer (Humac Norm Isokinetic Software System-USA. The participants will perform knee flexion and extension at angular velocities of 60°/s and 180°/s. The peak torque (Nm) will be recorded for each movement, which indicates the maximum strength of the quadriceps and hamstrings. Bilateral comparisons will be performed to assess muscle imbalances, which are potential injury risk factors. Quadriceps and hamstring muscles of the dominant leg will be also examined. The dominant lower extremity was defined as the preferred leg for kicking the ball. The researcher will use a moderate pace and load (50-100 W), followed by 10 min of dynamic stretching concentrating on the lower limbs to prepare every participant for the assessment of leg torque.
Measured: baseline
The General Self-Efficacy Scale (GSES)
The GSES is a self-report and unidimensional measure consisting of 10 items (e.g., "I can always manage to solve difficult problems if I try hard enough"). The total score ranges from 10 to 40, with higher scores indicating stronger belief that one's actions are responsible for successful outcomes.
Measured: baseline
Brief Resilience Scale (BRS)
Brief Resilience Scale (BRS) is a self-rated assessment developed to quantify people's ability to bounce back and cope in accordance to health-related stressors.The overarch objective of this test was to provide the ability to thrive in the face of adversity. In other words, those who are more resilient are better able to cope with life challenges. The BRS was first developed by Smith et al.. and was used in this study. It comprises a six-item scale, with total possible points ranging from to 6-30. Each item has possible responses ranging from1= strongly disagree, 2= disagree, 3= neutral, 4= agree, and 5= Strongly Agree. The validity and reliability for this scale has been examined, giving excellent psychometric properties that allows for efficient measurement of resilience.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start25 Jan 2025
- Primary completion25 Sep 2025
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Nourah Bint Abdulrahman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monira Aldhahi, Princess Nourah Bint Abdulrahman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026383
- Sponsor's protocol ID
- PNU-4
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Psychological Profiles of the Athletic Women and the Risk of Sport Injuries in Saudi Arabia
- ClinicalTrials.gov ID
- NCT07026383
- Acronym / sponsor ID
- PNU-4
- Conditions
- Healthy Volunteer, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Princess Nourah Bint Abdulrahman UniversityUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The participation of women in high-impact sports such as rugby and basketball has been steadily increasing in Saudi Arabia. These sports are known for their physical demands and competitive nature, which have heightened the incidence of sports-related injuries. Understanding the predictive factors for these injuries is critical for developing preventive strategies, reducing long-term health consequences, and reducing healthcare burdens. Therefore, this study aims to identify the predictive effect of physiological factors (e.g., muscle strength, anaerobic power, oxygen consumption) and psychological factors (e.g., self-efficacy, resilience) on sports injuries among female athletes in Saudi Arabia, particularly focusing on those involved in rugby and basketball.
A prospective cross-sectional design will be employed, involving a total of 30 female athletes aged 18-35 years actively participating in rugby and basketball. Data will be collected at the lifestyle research center through a series of physiological assessments, including maximal oxygen consumption, anaerobic power testing, isokinetic muscle strength testing, and psychological evaluations using validated questionnaires. The findings are expected to provide insights into the specific factors that increase injury risk among Saudi female athletes, offering targeted strategies for injury prevention. These strategies aim not only to minimize injuries but also to reduce associated healthcare costs, thereby supporting the sustainable growth of women's sports in Saudi Arabia. Ultimately, this study seeks to contribute to the broader objectives of Vision 2030 by promoting a vibrant sports culture and enhancing public health.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| athletic | – | Behavioral: performance test |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study participants will be selected from female athletes aged 18 to 35 years who are actively participating in rugby and basketball teams in Saudi Arabia. These athletes are involved in regular training and competitive matches, have at least one year of experience in their respective sports, and represent the population of active female sports enthusiasts within this age group in the region.
Key inclusion criteria (4 listed)
- Female athletes aged 18-35 years recruited from rugby and basketball teams in Saudi Arabia
- Actively involved in rugby and basketball
- Minimum of one year of experience in their respective sport
- Regular participation in training and competitive events
Key exclusion criteria (3 listed)
- Recent injury within the last six months that limits athletic performance Pregnancy
- Presence of any chronic medical condition that could influence study outcomes
- Uncontrolled diabetes or hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| performance testInjury risk was evaluated using the Lower Extremity Functional Test (LEFT), which involves eight agility drills performed consecutively on a diamond-shaped course without rest intervals. The test includes eight components-forward run, backward run, side shuffle, carioca, figure-eight run, 45-degree cuts, 90-degree cuts, and a counter vertical jump-along with the single-leg hop for distance, following a standardized testing protocol known to predict injury risk. Participants who took longer to complete the test were categorized into the high injury risk group, while those with shorter completion times were classified into the low injury risk group. | Behavioural | athletic |
Primary outcome
Maximal oxygen consumption test:
Time frame: baseline
subjects will complete symptom limited treadmill exercise tests using a modification of Balkes protocol, which has been previously used among individuals with obesity. Participants will be connected to a gas analyzing metabolic cart (mouthpiece) for the determination of oxygen uptake, ventilated carbon dioxide, lung volumes, and heart rate through a gas analysis system using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) and HR monitor (Polar H7, Kempele, Finland).The tests will be performed on a computerized treadmill allowing programmed adjustment of both speed and inclination components of the work rate. The gas exchange system measured the oxygen consumption (VO2) and carbon dioxide production (VCO2) throughout the test.
Wingate test
Time frame: baseline
The Wingate test will be performed on a cycle ergometer (Ergomedic 828E, Monark, Sweden). Participants will perform a 30-second all-out sprint against a resistance equivalent to 7.5% of their body weight. The test measures the peak power (in watts), average power, and rate of fatigue. These metrics provide insights into the anaerobic performance capabilities of athletes.
Isokinetic muscle strength
Time frame: baseline
testing will be conducted using an isokinetic dynamometer (Humac Norm Isokinetic Software System-USA. The participants will perform knee flexion and extension at angular velocities of 60°/s and 180°/s. The peak torque (Nm) will be recorded for each movement, which indicates the maximum strength of the quadriceps and hamstrings. Bilateral comparisons will be performed to assess muscle imbalances, which are potential injury risk factors. Quadriceps and hamstring muscles of the dominant leg will be also examined. The dominant lower extremity was defined as the preferred leg for kicking the ball. The researcher will use a moderate pace and load (50-100 W), followed by 10 min of dynamic stretching concentrating on the lower limbs to prepare every participant for the assessment of leg torque.
The General Self-Efficacy Scale (GSES)
Time frame: baseline
The GSES is a self-report and unidimensional measure consisting of 10 items (e.g., "I can always manage to solve difficult problems if I try hard enough"). The total score ranges from 10 to 40, with higher scores indicating stronger belief that one's actions are responsible for successful outcomes.
Brief Resilience Scale (BRS)
Time frame: baseline
Brief Resilience Scale (BRS) is a self-rated assessment developed to quantify people's ability to bounce back and cope in accordance to health-related stressors.The overarch objective of this test was to provide the ability to thrive in the face of adversity. In other words, those who are more resilient are better able to cope with life challenges. The BRS was first developed by Smith et al.. and was used in this study. It comprises a six-item scale, with total possible points ranging from to 6-30. Each item has possible responses ranging from1= strongly disagree, 2= disagree, 3= neutral, 4= agree, and 5= Strongly Agree. The validity and reliability for this scale has been examined, giving excellent psychometric properties that allows for efficient measurement of resilience.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Female, run by Princess Nourah Bint Abdulrahman University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen consumption test: (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.