University StudentsWE-UPNCT07275398
Experimental Study on Exercise and Well-being in University Students
A study testing Structured physical exercise program and Stress Management Program in people with University Students, run by Università degli Studi di Brescia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- University Students
- What is being tested?
- Structured physical exercise program and Stress Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2025to 16 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently enrolled in an undergraduate, graduate, or single-cycle degree program at the University of Brescia
- Adequate proficiency in Italian language
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Scienze Cliniche e Sperimentali, Settore di Psicologia
Brescia, Brescia, 25121
About this study
Official title: Psychophysical Well-being, Psychological Distress, and Physical Exercise: An Experimental Study in a Sample of 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).
Read more
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
- Being tested
- Structured physical exercise program, Stress Management Program
- Keywords
- University Students, Physical Exercise, Well-being
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured physical exercise programBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Structured physical exercise program; Behavioral: Stress Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Secondary outcomes (6)
Generalized Anxiety Disorder-7
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.
Measured: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Patient Health Questionnaire-9
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.
Measured: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Dropout intention
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.
Measured: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Perceived Self-Efficacy Scale
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.
Measured: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Academic Motivation Scale
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
Measured: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
WHOQOL-BREF
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.
Measured: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start3 Feb 2025
- Primary completion16 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for University StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Dagani, Università degli Studi di Brescia
- Investigators
- Alberto Ghilardi, Professor, Principal investigator, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275398
- Sponsor's protocol ID
- UNIBS_2024_eserciziowellbeing
- Acronym
- WE-UP
- Status last verified
- Oct 2025
- First submitted
- 27 Nov 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymized dataset excluding personally identifiable information and sensitive sociodemographic details. Specific variables to be included will be determined after data cleaning and privacy review.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysical Well-being, Psychological Distress, and Physical Exercise: An Experimental Study in a Sample of University Students.
- ClinicalTrials.gov ID
- NCT07275398
- Acronym / sponsor ID
- WE-UP / UNIBS_2024_eserciziowellbeing
- Conditions
- University Students
- Keywords
- University Students, Physical Exercise, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, Control group - Online Stress Management Program | Active comparator | Behavioral: Stress Management ProgramParticipants 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 2, Experimental Group - Physical Exercise Program plus Stress Management program | Experimental | Behavioral: Structured physical exercise program, Behavioral: Stress Management ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently enrolled in an undergraduate, graduate, or single-cycle degree program at the University of Brescia
- Adequate proficiency in Italian language
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured physical exercise programThe 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. | Behavioural | Group 2, Experimental Group - Physical Exercise Program plus Stress Management program |
| Stress Management Programbrief, 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. | Behavioural | Group 1, Control group - Online Stress Management Program, Group 2, Experimental Group - Physical Exercise Program plus Stress Management program |
Primary outcome
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.
6 secondary outcomes
Generalized Anxiety Disorder-7
Time frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Patient Health Questionnaire-9
Time frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Dropout intention
Time frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Perceived Self-Efficacy Scale
Time frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Academic Motivation Scale
Time frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
WHOQOL-BREF
Time frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. An anonymized dataset excluding personally identifiable information and sensitive sociodemographic details. Specific variables to be included will be determined after data cleaning and privacy review.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Ghilardi, Professor principal investigator
Università degli Studi di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured physical exercise program and Stress Management Program in people with University Students, run by Università degli Studi di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Health Questionnaire-12 (time frame: The outcome measure is collected before intervention, after intervention and at 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.