NCT07139249

Brief Summary

This study was done to investigate the impact of gender differences and exercise intensities on depression and anxiety symptoms among university students

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 17, 2025

Last Update Submit

August 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of the severity of depressive symptoms

    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 Outcomes (3)

  • assessment of severity of perceived anxiety symptoms

    at baseline and after 6 weeks

  • assessment of physical fitness

    at baseline and after 6 weeks

  • assessment of heart rate during exercise

    at baseline and after 6 weeks

Study Arms (6)

females with high intensity interval training

EXPERIMENTAL

It will consist of 14 female students; they will be receiving high intensity interval training.

Other: The high intensity interval training

males with high intensity interval training

ACTIVE COMPARATOR

It will consist of 14 male students; they will be receiving high intensity interval training.

Other: The high intensity interval training

females with moderate intensity continuous training.

EXPERIMENTAL

It will consist of 14 female students; they will be receiving moderate intensity continuous training

Other: The study moderate continuous training

males with moderate intensity continuous training.

ACTIVE COMPARATOR

It will consist of 14 male students; they will be receiving moderate intensity continuous training

Other: The study moderate continuous training

The non-exercise females group

NO INTERVENTION

It will consist of 14 female students; they will remain sedentary for the six-weeks intervention period.

The non-exercise males group

NO INTERVENTION

It will consist of 14 male students; they will remain sedentary for the six-weeks intervention period

Interventions

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.

females with high intensity interval trainingmales with high intensity interval 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

females with moderate intensity continuous training.males with moderate intensity continuous training.

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

out-patient clinic, faculty of physical therapy, Horus university

Damietta, Egypt

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersCoitus

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSexual Behavior

Central Study Contacts

Aya Mohamed Hassan Abo Elhassan, Assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 17, 2025

First Posted

August 24, 2025

Study Start

August 20, 2025

Primary Completion

January 20, 2026

Study Completion

February 1, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations