Experimental Study on Exercise and Well-being in University Students

NCT07275398 | Completed

• 1 other identifier: UNIBS_2024_eserciziowellbeing
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

University Students

Keywords

University Students; Physical Exercise; Well-being

Outcome Measures

Primary Outcomes (1)

• General Health Questionnaire-12

  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.

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

Secondary Outcomes (6)

• Generalized Anxiety Disorder-7

  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

• Perceived Self-Efficacy Scale

  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

Study Arms (2)

Group 1, Control group - Online Stress Management Program

ACTIVE COMPARATOR

Participants in the control group (Group 1) completed a brief, online, asynchronous stress management intervention based on the World Health Organization's Doing What Matters in Times of Stress program. The program consists of five self-guided modules grounded in Acceptance and Commitment Therapy principles, providing practical strategies to manage stress in daily life. One new module was released each week over a five-week period.

Behavioral: Stress Management Program

Group 2, Experimental Group - Physical Exercise Program plus Stress Management program

EXPERIMENTAL

Participants in the Group 2 completed the same online stress management program as the control group (Group 1), combined with a structured physical exercise program. The physical exercise program consisted of group sessions held twice a week for ten consecutive weeks. The training sessions included whole-body workouts combining aerobic and anaerobic free-body exercises. Students could choose among different types of exercise classes offered by the university sports center, all designed to have comparable intensity levels. All sessions were conducted by certified professional trainers, under the supervision of a qualified sports professional to ensure safety and consistency across activities.

Behavioral: Structured physical exercise program; Behavioral: Stress Management Program

Interventions

Stress Management Program BEHAVIORAL

brief, online, asynchronous stress management intervention based on the World Health Organization's Doing What Matters in Times of Stress program (WHO, 2020). The program consists of five self-guided modules grounded in Acceptance and Commitment Therapy principles, providing practical strategies to manage stress in daily life. One new module was released each week over a five-week period, and participants were encouraged to complete the exercises included between modules.

Group 1, Control group - Online Stress Management Program; Group 2, Experimental Group - Physical Exercise Program plus Stress Management program

Structured physical exercise program BEHAVIORAL

The physical exercise program consisted of group sessions held twice a week for ten consecutive weeks. The training sessions included whole-body workouts combining aerobic and anaerobic free-body exercises. Students could choose among different types of exercise classes offered by the university sports center, all designed to have comparable intensity levels. All sessions were conducted by certified professional trainers, under the supervision of a qualified sports professional to ensure safety and consistency across activities.

Group 2, Experimental Group - Physical Exercise Program plus Stress Management program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently enrolled in an undergraduate, graduate, or single-cycle degree program at the University of Brescia
• Adequate proficiency in Italian language

You may not qualify if:

• Any medical condition or illness contraindicating or limiting safe participation in physical exercise
• Serious physical injury (e.g., fracture) within the past 6 months
• Engagement in high levels of physical activity, defined as classification in the "high" category according to the International Physical Activity Questionnaire - Short Form (IPAQ-SF; Mannocci et al., 2010)

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

Dipartimento di Scienze Cliniche e Sperimentali, Settore di Psicologia

Brescia, Brescia, 25121, Italy

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Alberto Ghilardi, Professor

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Department of clinical and experimental science, University of Brescia

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: February 3, 2025
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication of the main study results.
• Access Criteria: Researchers with a legitimate scientific interest will be able to access the anonymized dataset and supporting documentation. Access will be granted via a public research data repository (e.g., Zenodo), and users will be required to comply with terms of use and appropriately cite the study. Specific variables included in the shared dataset will be determined following data cleaning and privacy review.

Locations

IT (1)