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NCT Number: NCT07140185

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

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.

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Key information

Conditions

Sleep Quality Behavior Dyssomnias Fatigue Mental Disorders Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Personal Satisfaction Physical Activity Psychological Well-Being Sedentary Behavior Sedentary Lifestlye Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Well-Being

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Regular Weekly Physical Activity Program

Behavioral

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 Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Psychological Well-Being (WHO-5 Well-Being Index)

    Time frame: 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.

  2. Mental Health (Depression, Anxiety and Stress Scale, DASS-21)

    Time frame: 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.

  3. Perceived Fatigue (Fatigue Severity Scale, FSS)

    Time frame: 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.

  4. Functional Endurance (6-Minute Walk Test, 6MWT)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Soumaya CHAABENE, PhD student

CONTACT

[email protected]

+216 22 699 019

Soumaya CHAABENE, PhD student

CONTACT

[email protected]

+216 22 699 019

Sponsors and collaborators

Lead sponsor

University of Sfax

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

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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