CHU de Besançon
Besançon, 25000, France
Location status: Recruiting
Location contact
Julie GIUSTINIANI, MD PhD
PRINCIPAL_INVESTIGATOR
Karine Charrière, PhD
CONTACT
Lilou DUQUET, PhD student
CONTACT
NCT Number: NCT06706349
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Besançon, 25000, France
Location status: Recruiting
Julie GIUSTINIANI, MD PhD
PRINCIPAL_INVESTIGATOR
Karine Charrière, PhD
CONTACT
Lilou DUQUET, PhD student
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks
Levels of urinary melatonin (in ng/mL) assessed as an indicator of circadian rhythm.
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).
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).
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).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Participant-reported data on sleep duration and quality using a daily sleep diary.
Time frame: Baseline only.
Chronotype assessment using the Horne and Östberg Scale, providing a score categorizing participants as morning, intermediate, or evening types.
Time frame: 12 weeks.
Number of physical activity sessions completed by participants over the course of the study.
Time frame: Baseline only.
Collection of sociodemographic data including age, gender, marital status, education level, and employment status.
Time frame: Baseline only.
Participants' history of engagement in structured physical activity (binary: Yes/No).
Time frame: 12 weeks.
Proportion of participants who prematurely discontinued the study intervention.
Time frame: Baseline to 12 weeks.
Analysis of the relationship between personality traits (assessed by validated scales) and adherence to intervention protocols.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
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.
Biological markers directly indicating alcohol consumption.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Biological markers indirectly indicating alcohol consumption.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol dependence evaluated using the French version of the Alcohol Dependence Scale (ADS-Fr).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Craving for alcohol assessed using the Obsessive-Compulsive Drinking Scale (OCDS)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Craving for alcohol assessed using Visual Analog Scales (VAS).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Influence of the craving profile on treatment success analyzed using predefined criteria.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
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.
Functional capacity assessed using the Chair Stand Test.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Functional capacity assessed using the 6-Minute Walk Test (6MWT).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical activity level measured using the Global Physical Activity Questionnaire (GPAQ).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical activity patterns documented using a dedicated physical activity calendar.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
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.
Measurement of waist circumference in centimeters.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Measurement of thigh circumference in centimeters.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Pulse rate measured in beats per minute (bpm).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Depression severity assessed using the Quick Inventory of Depressive Symptomatology (QIDS).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Anxiety levels evaluated using the State-Trait Anxiety Inventory (STAI).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Impulsive behaviors assessed using the UPPS-P Impulsive Behavior Scale.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Self-esteem assessed using the Rosenberg Self-Esteem Scale.
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
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 assessed using the Monetary Choice Questionnaire (MCQ-27).
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Motivational abilities evaluated using the Effort Expenditure for Rewards Task (EEfRT) on a cycle ergometer.
Contact information is provided by the study sponsor or research team.
Karine CHARRIERE, PhD
CONTACT
Magali NICOLIER, PhD
CONTACT
Centre Hospitalier Universitaire de Besancon
Other
Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder
Acronym: APhysOH
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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