Sleep QualityNCT07140185

Impact of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students

A study testing Regular Weekly Physical Activity Program and Weekend Warrior Physical Activity Program in people with Sleep Quality and Sedentary Lifestlye, run by University of Sfax at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Quality, Sedentary Lifestlye, Physical Activity
What is being tested?: Regular Weekly Physical Activity Program and Weekend Warrior Physical Activity Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteTunisia
Study dates: 1 Sep 2025to 25 Dec 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 to 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18 to 25 years.
Low level of physical activity, determined using the validated International Physical Activity Questionnaire (IPAQ) according to its scoring thresholds.
Provided written informed consent.
Available to participate in the entire intervention program and all planned assessments.

Who cannot join

Current use of medications that may affect sleep quality or alertness (e.g., sedative hypnotics, sedative antidepressants, psychostimulants).
History of serious medical conditions or any contraindication to moderate physical activity.
Morbid obesity.
Current pregnancy during the study period.
Participation in another intervention program simultaneously.

Trial locations and contacts

1 site in 1 country.

Tunisia1 site

Private Faculty of Health Sciences Sfax, Tunisia
Sfax, 3000

Other trials in Tunisia

About this study

Official title: Evaluation of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students: A Randomized Controlled Trial Comparing Regular Weekly Activity With a "Weekend Warrior" Pattern

This randomized controlled trial aims to compare the effects of a regular weekly physical activity program versus a "Weekend Warrior" activity pattern on sleep quality, physical well-being, and mental well-being in sedentary university students. Participants will be randomly assigned to one of the intervention groups or to a control group and assessed at baseline and after the intervention.

Read the detailed description

Sedentary behavior is a growing concern among university students and is associated with poor sleep quality, fatigue, and lower mental well-being. Physical activity interventions can improve these outcomes, but the optimal frequency and pattern of activity remain unclear. This randomized controlled trial will evaluate and compare the effects of a regular weekly physical activity schedule with those of a "Weekend Warrior" pattern, in which the recommended amount of exercise is concentrated in two sessions per week. Sedentary university students will be randomly assigned to one of two intervention groups or to a control group for an 8 week period. Sleep quality (measured by actigraphy), physical well-being, and mental well-being will be assessed before and after the intervention. The findings of this study may help to inform public health recommendations for physical activity patterns among young adults.

Conditions: Sleep Quality, Sedentary Lifestlye, Physical Activity, Well-being
Being tested: Regular Weekly Physical Activity Program, Weekend Warrior Physical Activity Program
Keywords: Sedentary lifestyle, University students, Physical activity, Exercise intervention, Weekend Warrior, Sleep quality, well-being, Mental health, Fatigue, Randomized controlled trial
Medical subject headings: Sleep Initiation and Maintenance Disorders, Motor Activity, Sedentary Behavior, Psychological Well-Being, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regular Weekly Physical Activity ProgramBehavioural
Structured physical activity sessions three times per week, 50 minutes each, over 8 weeks. Includes aerobic exercises, supervised by trained instructors. Goal is to distribute the recommended weekly activity evenly.
Weekend Warrior Physical Activity ProgramBehavioural
Same total weekly activity as Arm 1, but concentrated in 2 weekend sessions of 75 minutes each. Includes aerobic exercises, supervised by the same trained instructors.

Study groups in NCT07140185
Study group	Role	What they receive
Arm 1 - Regular Weekly Physical Activity	Experimental	Participants in this group will engage in structured physical activity sessions three times per week, each lasting 50 minutes, over a period of 8 weeks. The sessions include a combination of aerobic exercises, supervised by trained instructors. The goal is to distribute the recommended weekly activity evenly across the week. Receives: Behavioral: Regular Weekly Physical Activity Program
Arm 2 - Weekend Warrior Physical Activity	Experimental	Participants in this group will perform the same total weekly physical activity as Arm 1, but concentrated in 2 sessions during the weekend. Each session lasts approximately 75 minutes and includes aerobic exercises, supervised by the same trained instructors. Receives: Behavioral: Weekend Warrior Physical Activity Program
Arm 3 - Control/ No Intervention	No intervention	Participants in this group will maintain their usual lifestyle without any structured physical activity intervention during the study period. After study completion, they may be offered the Regular Weekly physical activity program.

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Efficiency (Actigraphy)
Sleep efficiency calculated as the ratio of total sleep time to time in bed, expressed as a percentage (%). ≥85% is considered good sleep, <85% indicates impaired sleep quality. Range: 0-100%. Higher percentages indicate better sleep efficiency.
Measured: Baseline (Week 0) and Post-intervention (Week 8)
Subjective Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Pittsburgh Sleep Quality Index total score ranges 0-21. Score ≤5 indicates good sleep quality, >5 indicates poor sleep quality. Higher scores indicate worse sleep.
Measured: Baseline (Week 0) and End of Intervention (Week 8)

Secondary outcomes (4)

Psychological Well-Being (WHO-5 Well-Being Index)
WHO-5 score ranges 0-25, converted to 0-100%. Higher scores indicate better well-being. Raw score <13 (<52%) suggests poor well-being.
Measured: Baseline (Week 0) and End of Intervention (Week 8)
Mental Health (Depression, Anxiety and Stress Scale, DASS-21)
DASS-21 measures depression, anxiety, and stress. Each subscale score ranges 0-42; higher scores indicate greater severity.
Measured: Baseline (Week 0) and End of Intervention (Week 8)
Fatigue (Fatigue Assessment Scale, FAS)
FAS a 10-item questionnaire rated on a five-point Likert scale (1 = "Never" to 5 = "Always"). Total scores range from 10 to 50, with scores ≥22 indicating substantial fatigue.
Measured: Baseline (Week 0) and End of Intervention (Week 8)
Functional Endurance (6-Minute Walk Test, 6MWT)
6-Minute Walk Test measures distance (meters) walked in 6 minutes along a flat corridor. Higher distance indicates better functional endurance.
Measured: Baseline (Week 0) and End of Intervention (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202525 Dec 2025

First posted24 Aug 2025
Study start1 Sep 2025
Primary completion25 Dec 2025
Study completion25 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sleep QualityStudies 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
Model description: This randomized controlled trial uses a parallel-group design in which sedentary university students are randomly assigned to one of three groups: a regular weekly physical activity schedule group, a 'Weekend Warrior' physical activity group, or a control group. Each group participates concurrently throughout the 8 week intervention period. The parallel structure allows direct comparison of the effects of different physical activity patterns on sleep quality, mental well-being, and physical well-being.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07140185
Sponsor's protocol ID: FMS110590-80-25
Status last verified: Aug 2025
First submitted: 14 Aug 2025
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: A decision on sharing individual participant data has not yet been made; plans will be determined after study completion and analysis.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students: A Randomized Controlled Trial Comparing Regular Weekly Activity With a "Weekend Warrior" Pattern
ClinicalTrials.gov ID: NCT07140185
Acronym / sponsor ID: FMS110590-80-25
Conditions: Sleep Quality, Sedentary Lifestlye, Physical Activity, Well-being
Keywords: Sedentary lifestyle, University students, Physical activity, Exercise intervention, Weekend Warrior, Sleep quality, well-being, Mental health
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: University of SfaxUniversity, hospital or other
Study start: 1 Sep 2025 (actual)
Primary completion: 25 Dec 2025 (actual)
Study completion: 25 Dec 2025 (actual)
First posted: 24 Aug 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: This randomized controlled trial uses a parallel-group design in which sedentary university students are randomly assigned to one of three groups: a regular weekly physical activity schedule group, a 'Weekend Warrior' physical activity group, or a control group. Each group participates concurrently throughout the 8 week intervention period. The parallel structure allows direct comparison of the effects of different physical activity patterns on sleep quality, mental well-being, and physical well-being.

Arm	Type	Receives
Arm 1 - Regular Weekly Physical Activity	Experimental	Behavioral: Regular Weekly Physical Activity ProgramParticipants in this group will engage in structured physical activity sessions three times per week, each lasting 50 minutes, over a period of 8 weeks. The sessions include a combination of aerobic exercises, supervised by trained instructors. The goal is to distribute the recommended weekly activity evenly across the week.
Arm 2 - Weekend Warrior Physical Activity	Experimental	Behavioral: Weekend Warrior Physical Activity ProgramParticipants in this group will perform the same total weekly physical activity as Arm 1, but concentrated in 2 sessions during the weekend. Each session lasts approximately 75 minutes and includes aerobic exercises, supervised by the same trained instructors.
Arm 3 - Control/ No Intervention	No intervention	–Participants in this group will maintain their usual lifestyle without any structured physical activity intervention during the study period. After study completion, they may be offered the Regular Weekly physical activity program.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Aged 18 to 25 years.
Low level of physical activity, determined using the validated International Physical Activity Questionnaire (IPAQ) according to its scoring thresholds.
Provided written informed consent.
Available to participate in the entire intervention program and all planned assessments.

Key exclusion criteria (5 listed)

Current use of medications that may affect sleep quality or alertness (e.g., sedative hypnotics, sedative antidepressants, psychostimulants).
History of serious medical conditions or any contraindication to moderate physical activity.
Morbid obesity.
Current pregnancy during the study period.
Participation in another intervention program simultaneously.

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
Regular Weekly Physical Activity ProgramStructured physical activity sessions three times per week, 50 minutes each, over 8 weeks. Includes aerobic exercises, supervised by trained instructors. Goal is to distribute the recommended weekly activity evenly.	Behavioural	Arm 1 - Regular Weekly Physical Activity
Weekend Warrior Physical Activity ProgramSame total weekly activity as Arm 1, but concentrated in 2 weekend sessions of 75 minutes each. Includes aerobic exercises, supervised by the same trained instructors.	Behavioural	Arm 2 - Weekend Warrior Physical Activity

Primary outcome

Sleep Efficiency (Actigraphy)
Time frame: Baseline (Week 0) and Post-intervention (Week 8)
Sleep efficiency calculated as the ratio of total sleep time to time in bed, expressed as a percentage (%). ≥85% is considered good sleep, <85% indicates impaired sleep quality. Range: 0-100%. Higher percentages indicate better sleep efficiency.
Subjective Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
Pittsburgh Sleep Quality Index total score ranges 0-21. Score ≤5 indicates good sleep quality, >5 indicates poor sleep quality. Higher scores indicate worse sleep.

4 secondary outcomes

Psychological Well-Being (WHO-5 Well-Being Index)
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
Mental Health (Depression, Anxiety and Stress Scale, DASS-21)
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
Fatigue (Fatigue Assessment Scale, FAS)
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
Functional Endurance (6-Minute Walk Test, 6MWT)
Time frame: Baseline (Week 0) and End of Intervention (Week 8)

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 10 Sep 2026.
Individual participant dataSharing planned: Undecided. A decision on sharing individual participant data has not yet been made; plans will be determined after study completion and analysis.

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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.

Jihen JDIDI TRABELSI, Professor study director

Faculty of Medicine of Sfax, Tunisia

Riadh DAHMEN, Professor study director

Higher Institute of Sport and Physical Education of Sfax, TUNISIA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 5 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 10 Sep 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 Tunisia. 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?

Sleep Efficiency (Actigraphy) (time frame: Baseline (Week 0) and Post-intervention (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07140185.

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 10 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.