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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Sfax

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Arm 1 - Regular Weekly Physical ActivityExperimental treatment 1 intervention
Group B: Arm 2 - Weekend Warrior Physical ActivityExperimental treatment 1 intervention
Group C: Arm 3 - Control / No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Week 0) and Post-intervention (Week 8)
2

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.

Time frame
Baseline (Week 0) and End of Intervention (Week 8)

Secondary outcomes

1

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.

Time frame
Baseline (Week 0) and End of Intervention (Week 8)
2

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.

Time frame
Baseline (Week 0) and End of Intervention (Week 8)
3

Perceived Fatigue (Fatigue Severity Scale, FSS)

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.

Time frame
Baseline (Week 0) and End of Intervention (Week 8)
4

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.

Time frame
Baseline (Week 0) and End of Intervention (Week 8)

Other outcomes

Sponsors and contacts

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