Effect of Adapted Physical Activity on Sleep Quality in People With Alcohol Use Disorder

ConditionAlcohol Use Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorCentre Hospitalier Universitaire de Besancon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Decompensated heart failure

Complex ventricular arrhythmias

Severe uncontrolled hypertension

Pulmonary hypertension (>60 mmHg)

Trial design

Design model

Parallel

Treatments tested in this trial

APA managed by qualified instructor
Behavioral
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.
Autonomous APA
Behavioral
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Managed adapted physical activityExperimental treatment 1 intervention

Group B: Autonomous adapted physical activityPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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