Impact of Gender Difference and Exercise Intensities on Depression and Anxiety Symptoms Among University Students

August 17, 2025 updated by: Aya Mohammed Hassan, Cairo University
This study was done to investigate the impact of gender differences and exercise intensities on depression and anxiety symptoms among university students

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Depression among university students is a growing concern due to factors such as separation from family, transition to a performance-based environment, financial stressors, and uncertainty about postgraduation. An estimated 71% of Egyptian university students have at least minor depression. Depression is associated with lower academic performance and can lead to substance abuse, chronic conditions, and premature mortality. Despite the availability of effective treatment, only one in five university students receives minimally adequate treatment. Physical exercise is suggested as an affordable, low-cost, non-pharmacological treatment for depression and anxiety. Exercise can effectively relieve anxiety symptoms, and a study will evaluate depression and anxiety symptoms based on gender and exercise intensity among university students.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Damieta, Egypt
        • out-patient clinic, faculty of physical therapy, Horus university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a student in higher education
  • Being single
  • Age between 18 and 25 years of both sexes
  • Accepting the principle of randomization in the trial.
  • The body mass index is 18.5-24.9 kg/m².
  • Diagnosed by psychiatrist as having a mild to moderate degree of anxiety and depression.
  • Having scores of 7-24 on the Hamilton Rating Scale for Depression.
  • Having scores of 17-30 on the Hamilton Anxiety Rating Scale.

Exclusion Criteria:

  • Neurological history such as illness or head trauma
  • Present severe and unstable respiratory disease
  • History of heart defect or cardiovascular disease or any other medical conditions prohibiting high-intensity sport or physical activity
  • Being professional athlete.
  • Involved in regular routine of exercises
  • Taking medication for mental health history of any neurological disorders like neuropathy or seizures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: females with high intensity interval training
It will consist of 14 female students; they will be receiving high intensity interval training.
Other: The high intensity interval training
The training program for students in groups 1 and 2 involves high intensity interval training exercises, conducted three times per week for six weeks. The sessions include a 10-minute warm-up at 40% Heart Rate Reserve, four high-intensity work periods at 85-95% Heart Rate Reserve, three low-intensity work periods at 60-70% Heart Rate Reserve, and a 5- 10 minute cool down at 30% Heart Rate Reserve.
Active Comparator: males with high intensity interval training
It will consist of 14 male students; they will be receiving high intensity interval training.
Other: The high intensity interval training
The training program for students in groups 1 and 2 involves high intensity interval training exercises, conducted three times per week for six weeks. The sessions include a 10-minute warm-up at 40% Heart Rate Reserve, four high-intensity work periods at 85-95% Heart Rate Reserve, three low-intensity work periods at 60-70% Heart Rate Reserve, and a 5- 10 minute cool down at 30% Heart Rate Reserve.
Experimental: females with moderate intensity continuous training.
It will consist of 14 female students; they will be receiving moderate intensity continuous training
Other: The study moderate continuous training
All students in groups 3&4 will receive moderate continuous training 3 times per week for 6 weeks. Each session 40 to 50 minutes included a 5 to 10 minute warm-up, fo followed by 30 minutes of moderate aerobic exercise (treadmill walking exercise) with constant intensity at 60% to 70% Heart Rate Reserve and 5 to 10 minutes cool-down
Active Comparator: males with moderate intensity continuous training.
It will consist of 14 male students; they will be receiving moderate intensity continuous training
Other: The study moderate continuous training
All students in groups 3&4 will receive moderate continuous training 3 times per week for 6 weeks. Each session 40 to 50 minutes included a 5 to 10 minute warm-up, fo followed by 30 minutes of moderate aerobic exercise (treadmill walking exercise) with constant intensity at 60% to 70% Heart Rate Reserve and 5 to 10 minutes cool-down
No Intervention: The non-exercise females group
It will consist of 14 female students; they will remain sedentary for the six-weeks intervention period.
No Intervention: The non-exercise males group
It will consist of 14 male students; they will remain sedentary for the six-weeks intervention period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assessment of the severity of depressive symptoms
Time Frame: at baseline and after 6 weeks
The Hamilton Rating Scale for Depression will be used to assess the severity of depressive symptoms in students across six groups. The 17-item version ranges from 0 to 54, with scores ranging from 0 to 24. Scores between 0 and 6 indicate no depression, while scores between 7 and 17 indicate mild, 18-24 indicate moderate, and 24+ over 24 indicate severe depression. A decrease in scores of at least 50% indicates response, and scores of 7 or less after treatment indicate remission. The 17-item version has adequate reliability and validity.
at baseline and after 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
assessment of severity of perceived anxiety symptoms
Time Frame: at baseline and after 6 weeks
The Hamilton Rating Scale for Anxiety is a tool used to assess the severity of perceived anxiety symptoms. It consists of 14 symptom-defined elements, scoring from 0 to 4 (severe). The score range is 0 to 56, with scores above 17/56 indicating mild anxiety, 25-30 indicating moderate anxiety, and >30 indicating severe anxiety. It has good psychometric properties.
at baseline and after 6 weeks
assessment of physical fitness
Time Frame: at baseline and after 6 weeks
The Harvard Step Test is a physical fitness index that measures an individual's ability to recover from muscular work and perform muscular tasks. It is performed on a 33 cm bench at 30 steps per minute, with heart rate measured every two seconds. The test is valid for estimating the cardiorespiratory fitness of college students and can be divided into three categories: excellent, good, average, and poor. The physical efficiency index rating ranges from 96 to 115, with the highest rating being excellent for males and the lowest being poor. The test is a reliable tool for assessing physical fitness.
at baseline and after 6 weeks
assessment of heart rate during exercise
Time Frame: at baseline and after 6 weeks
A pulse oximeter will be used to continuously monitor heart rate during exercise, ensuring the target heart rate (THR) remains within the pre-calculated value. The heart rate will be measured and monitored for all participants using the Karvonen formula. The process involves cleaning the index finger, placing the pulse oximeter on the index, and keeping the pulse for at least a minute until the reading stabilizes.
at baseline and after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Aya-Phd

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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