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

Not Applicable

Not yet recruiting

• Conditions: Sleep Quality; Sedentary Lifestlye; Physical Activity; Well-being

• Registration Number: NCT07140185
• Lead Sponsor: University of Sfax

Brief Summary

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.

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 8-10 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Study Start: 2025-09-15
• Primary Completion: 2025-10-05
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency (Actigraphy)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Psychological Well-Being (WHO-5 Well-Being Index)	Baseline (Week 0) and End of Intervention (Week 8)	WHO-5 score ranges 0-25, converted to 0-100%. Higher scores indicate better well-being. Raw score \<13 (\<52%) suggests poor well-being.
Mental Health (Depression, Anxiety and Stress Scale, DASS-21)	Baseline (Week 0) and End of Intervention (Week 8)	DASS-21 measures depression, anxiety, and stress. Each subscale score ranges 0-42; higher scores indicate greater severity.
Perceived Fatigue (Fatigue Severity Scale, FSS)	Baseline (Week 0) and End of Intervention (Week 8)	FSS is a 9-item questionnaire. Items scored 1-7; final score = mean (range 1-7). Higher scores indicate more severe fatigue. Score ≥4 indicates clinically significant fatigue.
Functional Endurance (6-Minute Walk Test, 6MWT)	Baseline (Week 0) and End of Intervention (Week 8)	6-Minute Walk Test measures distance (meters) walked in 6 minutes along a flat corridor. Higher distance indicates better functional endurance.

Trial Locations

Locations (1)

Private Faculty of Health Sciences Sfax, Tunisia; 🇹🇳 Sfax, Tunisia