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Completed

NCT Number: NCT07275398

Experimental Study on Exercise and Well-being in University Students

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.

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Key information

Conditions

University Students Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dipartimento di Scienze Cliniche e Sperimentali, Settore di Psicologia

Brescia, 25121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Generalized Anxiety Disorder-7

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

    Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006): a 7-item self-report questionnaire assessing state anxiety symptoms over the past two weeks. Items are rated on a 4-point scale (0 = "Not at all", 3 = "Nearly every day"), and the total score is summed, with higher scores indicating more severe anxiety.

  2. Patient Health Questionnaire-9

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

    Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001): a 9-item instrument widely used for screening and assessing the severity of depressive symptoms. Items are rated on a 4-point scale (0 = "Not at all", 3 = "Nearly every day"), and the total score is summed, with higher scores reflecting more severe depressive symptoms.

  3. Dropout intention

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

    Dropout Intention Scale - adapted version (Biasi et al., 2017; De Vincenzo, 2024; Hardre & Reeve, 2003): this 4-item scale measures students' intentions to withdraw from university, assessing the frequency of dropout-related thoughts and intentions. Items are rated on a 5-point Likert scale (1 = "Never", 5 = "Always"), and the mean score represents overall dropout intention, with higher scores indicating stronger intentions.

  4. Perceived Self-Efficacy Scale

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

    Perceived Self-Efficacy Scale (SASP; Pastorelli & Picconi, 2001): This 9-item scale assesses students' perceived ability to focus on and manage academic tasks. Items are rated on a 5-point Likert scale (1 = "Not capable at all", 5 = "Fully capable"), and the final score is the mean of all items, with higher scores indicating greater perceived academic self-efficacy.

  5. Academic Motivation Scale

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

    Academic Motivation Scale (AMS; Alivernini & Lucidi, 2008): Based on Self-Determination Theory (Vallerand et al., 1992), the adapted AMS assesses students' academic motivation across five subscales: Amotivation, External Regulation, Introjected Regulation, Identified Regulation, and Intrinsic Regulation. Each subscale has four items rated on an 11-point Likert scale (0 = "Not at all true", 10 = "Completely true"), with higher scores indicating stronger endorsement. In this study, only the Amotivation subscale was analyzed separately, while the other four subscales were combined into two composite indices (De Vincenzo, 2024): AMS Controlled Motivation (External + Introjected Regulation) and AMS Autonomous Motivation (Identified + Intrinsic Regulation), each ranging from 0 to 20. Controlled Motivation reflects engagement due to external or internal pressures, whereas Autonomous Motivation reflects engagement driven by personal interest or value

  6. WHOQOL-BREF

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

    The WHOQOL-BREF is a 26-item instrument developed by the World Health Organization to assess overall quality of life. It includes four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Higher scores indicate better perceived quality of life in each domain.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Acronym: WE-UP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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