Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- APA managed by qualified instructor
- Conditions
- Alcohol Use Disorder
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sleep duration measured by actigraphy.
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This feasibility study aims to assess interest, recruitment, and adherence to a supervised physical activity (APA) program among individuals with Alcohol Use Disorder (AUD). It also investigates the program's impact on sleep quality and efficiency. Key objectives include evaluating recruitment feasibility, assessing randomization acceptance, quantifying adherence rates, and identifying sensitive sleep assessment tools. The study will explore whether APA improves sleep outcomes in AUD patients with sleep complaints, laying groundwork for larger-scale research.
Participants will engage in APA sessions, complete sleep assessments (including sleep diaries and psychometric scales), and provide sociodemographic data and past activity adherence.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects aged 18 to 65 years inclusive
- •Present an Alcohol Use Disorder (AUD) with at least 2 positive items as defined by the DSM-5
- •Present a sleep complaint with a score on the Pittsburgh Sleep Quality Index (PSQI) ≥ 5
- •Present active alcohol consumption with at least 6 days of excessive alcohol consumption in the last 4 weeks
- •Speak and understand French
- •Live within 30 minutes of the University Hospital of Besançon
- •Treatment allowed if stabilized for at least 4 weeks
- •Signature of informed consent indicating that the subject has understood the purpose and procedures required by the study and agrees to participate and comply with the requirements and restrictions inherent to the study
- •Signed automobile safety contract:
- •The participant agrees to hand over the keys to their vehicle if necessary.
Exclusion Criteria
- •Decompensated heart failure
- •Complex ventricular arrhythmias
- •Severe uncontrolled hypertension
- •Pulmonary hypertension (\>60 mmHg)
- •Myocarditis or acute pericardial effusion
- •Severe obstructive cardiomyopathy
- •Severe and/or symptomatic aortic stenosis
- •All acute illnesses
- •All decompensated or unstable chronic conditions
- •Significant malnutrition
Arms & Interventions
Managed adapted physical activity
Participants will receive 3 weekly sessions of supervised adapted physical activity (APA) starting from Visit 3.
Intervention: APA managed by qualified instructor
Autonomous adapted physical activity
Participants in this arm will receive a leaflet summarizing WHO recommendations on physical activity at the start of the study.
Intervention: Autonomous APA
Outcomes
Primary Outcomes
Sleep duration measured by actigraphy.
Time Frame: Baseline, 6 weeks (midpoint), 12 weeks (end of sessions), and 14 weeks (2 weeks post-intervention)
Objective measurement of sleep duration (in minutes) using actigraphy over the course of the study.
Circadian parameters measured by urinary melatonin levels.
Time Frame: Baseline, 6 weeks, 12 weeks, and 14 weeks
Levels of urinary melatonin (in ng/mL) assessed as an indicator of circadian rhythm.
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).
Time Frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Subjective sleep quality measured using the PSQI, a validated scale ranging from 0 (better quality) to 21 (poor quality).
Insomnia severity measured by Insomnia Severity Index (ISI).
Time Frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Evaluation of insomnia severity using ISI, a composite scale ranging from 0 (no clinically significant insomnia) to 28 (severe insomnia).
Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS).
Time Frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Subjective evaluation of daytime sleepiness using ESS, ranging from 0 (no sleepiness) to 24 (severe sleepiness).
Sleep-wake patterns measured by sleep diary.
Time Frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Participant-reported data on sleep duration and quality using a daily sleep diary.
Morningness-eveningness preferences measured by Horne and Östberg Scale.
Time Frame: Baseline only.
Chronotype assessment using the Horne and Östberg Scale, providing a score categorizing participants as morning, intermediate, or evening types.
Adherence to treatment measured by completed APA sessions.
Time Frame: 12 weeks.
Number of physical activity sessions completed by participants over the course of the study.
Sociodemographic characteristics collected at baseline.
Time Frame: Baseline only.
Collection of sociodemographic data including age, gender, marital status, education level, and employment status.
Previous adherence to physical activity.
Time Frame: Baseline only.
Participants' history of engagement in structured physical activity (binary: Yes/No).
Dropout rate during intervention.
Time Frame: 12 weeks.
Proportion of participants who prematurely discontinued the study intervention.
Impact of personality traits on treatment adherence.
Time Frame: Baseline to 12 weeks.
Analysis of the relationship between personality traits (assessed by validated scales) and adherence to intervention protocols.
Secondary Outcomes
- Alcohol Consumption(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Direct Markers of Alcohol Use(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Indirect Markers of Alcohol Use(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Alcohol Dependence (ADS-Fr Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Alcohol Craving (OCDS Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Alcohol Craving (VAS Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Impact of Craving Profile on Treatment Outcome(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Risk of Transition to Compulsive Exercise (EDS-R Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Capacity (Chair Stand Test)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Capacity (6-Minute Walk Test)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Activity Level (GPAQ Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Activity Level (Physical Activity Calendar)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Body Mass Index (BMI)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Waist Circumference (WC)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Thigh Circumference (TC)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Blood Pressure (BP)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Pulse Rate(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Depression (QIDS Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Anxiety (STAI Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Impulsivity (UPPS-P Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Self-Esteem (Rosenberg Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Quality of Life (WHOQOL-BREF Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Decision-Making Abilities (MCQ-27 Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Motivational Abilities (EEfRT Task)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)