- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07139249
- Original Trial
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
84
Phase
- 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
- Name: Aya Mohamed HASSAN Abo Elhassan, Assistant lecturer
- Phone Number: 01220042634
- Email: aaboelhassan@horus.edu.eg
Study Locations
-
-
-
Damieta, Egypt
- out-patient clinic, faculty of physical therapy, Horus university
-
Contact:
- Aya Mohamed HASSAN Abo Elhassan, Assistant lecturer
- Phone Number: 01220042634
- Email: aaboelhassan@horus.edu.eg
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: females with high intensity interval training
It will consist of 14 female students; they will be receiving 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.
|
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
|
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
|
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
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
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
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)
August 20, 2025
Primary Completion (Estimated)
January 20, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
August 17, 2025
First Submitted That Met QC Criteria
August 17, 2025
First Posted (Actual)
August 24, 2025
Study Record Updates
Last Update Posted (Actual)
August 24, 2025
Last Update Submitted That Met QC Criteria
August 17, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
-
Bekelu Teka WorkuJimma UniversityNot yet recruitingPrenatal Depression | Mental Health Related Quality of Life | Maternal Postpartum Depression | Paternal Postpartum DepressionEthiopia
Clinical Trials on The high intensity interval training
-
University of MichiganCompletedGlucose IntoleranceUnited States
-
Universidad SurcolombianaMaciste Macias; Gilberto AstaizaRecruiting
-
Kuopio Research Institute of Exercise MedicineKuopio University Hospital; University of Basel; University of Eastern Finland; Social Insurance Institution, FinlandTerminatedUnstable Angina Pectoris | Acute Myocardial Infarction | Recurrent Myocardial InfarctionFinland
-
University of CadizInstituto de investigación e innovación biomédica de CádizActive, not recruitingDiabetes Mellitus, Type 2Spain
-
Riphah International UniversityCompleted
-
Cairo UniversityKasr El Aini HospitalCompletedDiabetes Mellitus, Type 2Egypt
-
Universidad Santo TomasCompletedMetabolic DiseasesColombia
-
Oslo University HospitalUniversity of OsloUnknown
-
National Institute of Cardiology, Laranjeiras,...WithdrawnObesity | Overweight | Physical ActivityBrazil
-
Wu JiarunCompletedBurnout,Motivation,Stress,Mental ToughnessMalaysia