An interventional study of APA managed by qualified instructor and Autonomous APA in Alcohol Use Disorder, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Supportive care
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 40 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Signed automobile safety contract:
Exclusion Criteria:
Participants will receive 3 weekly sessions of supervised adapted physical activity (APA) starting from Visit 3.
Behavioral: APA managed by qualified instructor
Participants in this arm will receive a leaflet summarizing WHO recommendations on physical activity at the start of the study.
Behavioral: Autonomous APA
Each session will be led by a qualified APA professional and will include a mix of aerobic, anaerobic, and 'mind-body' activities like yoga, tailored to participant preferences. Intensity will range from moderate to vigorous, with activities such as walking, cycling, and club-based exercises for at least 20 minutes per session. Participants will be progressively involved in session planning to support continued practice post-study. Heart rate monitoring will be used during exercises like the 6-minute walk test and chair rise test, while a daily activity calendar will help ensure adherence, documenting session dates, durations, subjective intensity, and activity type.
A leaflet highlighting the importance of non-sedentary behavior according to WHO recommendations will be provided to them. They will have the opportunity to engage in physical activity autonomously according to their preference.
Sleep duration measured by actigraphy.
Objective measurement of sleep duration (in minutes) using actigraphy over the course of the study.
Time frame: Baseline, 6 weeks (midpoint), 12 weeks (end of sessions), and 14 weeks (2 weeks post-intervention)
Circadian parameters measured by urinary melatonin levels.
Levels of urinary melatonin (in ng/mL) assessed as an indicator of circadian rhythm.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).
Subjective sleep quality measured using the PSQI, a validated scale ranging from 0 (better quality) to 21 (poor quality).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Insomnia severity measured by Insomnia Severity Index (ISI).
Evaluation of insomnia severity using ISI, a composite scale ranging from 0 (no clinically significant insomnia) to 28 (severe insomnia).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS).
Subjective evaluation of daytime sleepiness using ESS, ranging from 0 (no sleepiness) to 24 (severe sleepiness).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Sleep-wake patterns measured by sleep diary.
Participant-reported data on sleep duration and quality using a daily sleep diary.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Morningness-eveningness preferences measured by Horne and Östberg Scale.
Chronotype assessment using the Horne and Östberg Scale, providing a score categorizing participants as morning, intermediate, or evening types.
Time frame: Baseline only.
Adherence to treatment measured by completed APA sessions.
Number of physical activity sessions completed by participants over the course of the study.
Time frame: 12 weeks.
Sociodemographic characteristics collected at baseline.
Collection of sociodemographic data including age, gender, marital status, education level, and employment status.
Time frame: Baseline only.
Previous adherence to physical activity.
Participants' history of engagement in structured physical activity (binary: Yes/No).
Time frame: Baseline only.
Dropout rate during intervention.
Proportion of participants who prematurely discontinued the study intervention.
Time frame: 12 weeks.
Impact of personality traits on treatment adherence.
Analysis of the relationship between personality traits (assessed by validated scales) and adherence to intervention protocols.
Time frame: Baseline to 12 weeks.
Alcohol Consumption
Daily alcohol consumption reported in standard units (equivalent to 10g of alcohol) using the Timeline Follow Back (TLFB) method.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Direct Markers of Alcohol Use
Biological markers directly indicating alcohol consumption.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Indirect Markers of Alcohol Use
Biological markers indirectly indicating alcohol consumption.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Dependence (ADS-Fr Score)
Alcohol dependence evaluated using the French version of the Alcohol Dependence Scale (ADS-Fr).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Craving (OCDS Score)
Craving for alcohol assessed using the Obsessive-Compulsive Drinking Scale (OCDS)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Craving (VAS Score)
Craving for alcohol assessed using Visual Analog Scales (VAS).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Impact of Craving Profile on Treatment Outcome
Influence of the craving profile on treatment success analyzed using predefined criteria.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Risk of Transition to Compulsive Exercise (EDS-R Score)
Risk of developing compulsive exercise behaviors evaluated using the Exercise Dependence Scale-Revised (EDS-R).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Capacity (Chair Stand Test)
Functional capacity assessed using the Chair Stand Test.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Capacity (6-Minute Walk Test)
Functional capacity assessed using the 6-Minute Walk Test (6MWT).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Activity Level (GPAQ Score)
Physical activity level measured using the Global Physical Activity Questionnaire (GPAQ).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Activity Level (Physical Activity Calendar)
Physical activity patterns documented using a dedicated physical activity calendar.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Body Mass Index (BMI)
Calculated as weight in kilograms divided by the square of height in meters (kg/m²).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Waist Circumference (WC)
Measurement of waist circumference in centimeters.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Thigh Circumference (TC)
Measurement of thigh circumference in centimeters.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Blood Pressure (BP)
Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Pulse Rate
Pulse rate measured in beats per minute (bpm).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Depression (QIDS Score)
Depression severity assessed using the Quick Inventory of Depressive Symptomatology (QIDS).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Anxiety (STAI Score)
Anxiety levels evaluated using the State-Trait Anxiety Inventory (STAI).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Impulsivity (UPPS-P Score)
Impulsive behaviors assessed using the UPPS-P Impulsive Behavior Scale.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Self-Esteem (Rosenberg Score)
Self-esteem assessed using the Rosenberg Self-Esteem Scale.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Quality of Life (WHOQOL-BREF Score)
Quality of life assessed using the WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Decision-Making Abilities (MCQ-27 Score)
Decision-making abilities assessed using the Monetary Choice Questionnaire (MCQ-27).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Motivational Abilities (EEfRT Task)
Motivational abilities evaluated using the Effort Expenditure for Rewards Task (EEfRT) on a cycle ergometer.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Plan to share: No
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Centre Hospitalier Universitaire de Besancon