Experimental Study on Exercise and Well-being in University Students

NCT ID: NCT07275398

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-09-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1, Control group - Online Stress Management Program

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.

Group Type: ACTIVE_COMPARATOR

Stress Management Program

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

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.

Group Type: EXPERIMENTAL

Structured physical exercise program

Intervention Type: 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.

Stress Management Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Stress Management Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Jessica Dagani

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Ghilardi, Professor

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

Dipartimento di Scienze Cliniche e Sperimentali, Settore di Psicologia

Brescia, Brescia, Italy

Countries

Italy

Other Identifiers

UNIBS_2024_eserciziowellbeing

Identifier Type: -

Identifier Source: org_study_id