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

NCT07140185 | Not Yet Recruiting

• 1 other identifier: FMS110590-80-25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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; Fatigue; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (4)

• Psychological Well-Being (WHO-5 Well-Being Index)

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

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

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

• Perceived Fatigue (Fatigue Severity Scale, FSS)

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

• Functional Endurance (6-Minute Walk Test, 6MWT)

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

Study Arms (3)

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.

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.

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.

Interventions

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.

Arm 1 - Regular Weekly Physical Activity

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.

Arm 2 - Weekend Warrior Physical Activity

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sfax: lead

Study Sites (1)

Private Faculty of Health Sciences Sfax, Tunisia

Sfax, 3000, Tunisia

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Motor Activity; Sedentary Behavior; Psychological Well-Being; Fatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior; Personal Satisfaction; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jihen JDIDI TRABELSI, Professor

  Faculty of Medicine of Sfax, Tunisia

  STUDY DIRECTOR

• Riadh DAHMEN, Professor

  Higher Institute of Sport and Physical Education of Sfax, TUNISIA

  STUDY DIRECTOR

Central Study Contacts

Soumaya CHAABENE, PhD student

CONTACT

+216 22 699 019; soumaya_chaabane@upsat.tn

Soumaya CHAABENE, PhD student

CONTACT

+216 22 699 019; mayassou115@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 8-10 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.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 24, 2025
• Study Start: September 15, 2025
• Primary Completion: October 5, 2025
• Study Completion: December 20, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

TU (1)