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Clinical Trials/NCT07275398
NCT07275398CompletedNot Applicable

Psychophysical Well-being, Psychological Distress, and Physical Exercise: An Experimental Study in a Sample of University Students.

Università degli Studi di Brescia2 sites in 1 country91 target enrollmentStarted: February 3, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
91
Locations
2
Primary Endpoint
General Health Questionnaire-12

Study Overview

Brief Summary

The goal of this randomized controlled trial is to to evaluate the effectiveness of a structured physical exercise program in improving university students' well-being. The study involves university students who volunteered to participate in a 10-week intervention designed to enhance their physical and psychological well-being.

The main question it aims to answer is: does participation in the structured physical exercise program lead to greater improvements in psychophysical well-being compared to the control group? Researchers will compare the experimental group (Group 2: structured physical activity program + stress management program) with the active control group (Group 1: stress management program only) to determine whether adding structured physical activity components produces additional benefits. Participants in the experimental Group will engage in a 10 week supervised physical activity program, twice a week, provided by the university sports center, and will attend an online asynchronous stress management program including 5 modules and lasting 5 weeks (one module per week).

Participants in the active control group will only attend the online asynchronous stress management program.

Participants of both groups will complete questionnaires at three time points (baseline, post-intervention, and 3-month follow-up) assessing well-being, psychological distress, quality of life, academic motivation and self-efficacy.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • are: (a) being currently enrolled at a the university of Brescia, and (b) having sufficient proficiency in the Italian language.

Exclusion Criteria

  • are: (a) any physical condition or illness that would prevent or make exercise unsafe, (b) serious physical injuries (e.g., fractures) within the previous six months, and (c) regular engagement in high-intensity physical activity, defined as belonging to the "high" physical activity level according to the International Physical Activity Questionnaire - Short Form (IPAQ-SF, Mannocci et al., 2010), which classifies individuals into three levels of physical activity (low, moderate, and high).

Outcomes

Primary Outcomes

General Health Questionnaire-12

Time Frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up

The GHQ-12 (Goldberg \& Blackwell, 1970) served as the primary outcome measure, assessing overall distress and general well-being. Items are rated on a 4-point Likert scale (0 = "Not at all", 3 = "Much more than usual"), and total scores are summed, with higher scores indicating greater distress.

Secondary Outcomes

  • Generalized Anxiety Disorder-7(The outcome measure is collected before intervention, after intervention and at 3 months follow-up)
  • Perceived Self-Efficacy Scale(The outcome measure is collected before intervention, after intervention and at 3 months follow-up)
  • Patient Health Questionnaire-9(The outcome measure is collected before intervention, after intervention and at 3 months follow-up)
  • Dropout intention(The outcome measure is collected before intervention, after intervention and at 3 months follow-up)
  • Academic Motivation Scale(The outcome measure is collected before intervention, after intervention and at 3 months follow-up)
  • WHOQOL-BREF(The outcome measure is collected before intervention, after intervention and at 3 months follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jessica Dagani

PhD Candidate, Department of clinical and experimental science, University of Brescia

Università degli Studi di Brescia

Study Sites (2)

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