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

NCT06706349 | Recruiting

• 1 other identifier: 2024/863
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (12)

• Sleep duration measured by actigraphy.

  Objective measurement of sleep duration (in minutes) using actigraphy over the course of the study.

  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.

  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).

  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).

  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).

  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.

  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.

  Baseline only.

• Adherence to treatment measured by completed APA sessions.

  Number of physical activity sessions completed by participants over the course of the study.

  12 weeks.

• Sociodemographic characteristics collected at baseline.

  Collection of sociodemographic data including age, gender, marital status, education level, and employment status.

  Baseline only.

• Previous adherence to physical activity.

  Participants' history of engagement in structured physical activity (binary: Yes/No).

  Baseline only.

• Dropout rate during intervention.

  Proportion of participants who prematurely discontinued the study intervention.

  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.

  Baseline to 12 weeks.

Secondary Outcomes (24)

• 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.

Study Arms (2)

Managed adapted physical activity

EXPERIMENTAL

Participants will receive 3 weekly sessions of supervised adapted physical activity (APA) starting from Visit 3.

Behavioral: APA managed by qualified instructor

Autonomous adapted physical activity

PLACEBO COMPARATOR

Participants in this arm will receive a leaflet summarizing WHO recommendations on physical activity at the start of the study.

Behavioral: Autonomous APA

Interventions

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.

Managed adapted physical activity

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.

Autonomous adapted physical activity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The keys will be returned when the blood alcohol level is below 0.25 mg/L
• The participant agrees to name one or more people to contact in case the medical staff deems the participant unfit to return home alone.
• Affiliation to a French social security system or beneficiary of such a system
• Postmenopausal women for at least 24 months, surgically sterilized, or, for women of childbearing age, using an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches) (self-reported)

You may not qualify if:

• 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
• Extreme fatigue and/or manifest physical incapacity
• Severe anemia
• Severe intoxication (psychoactive substances)
• Severe withdrawal syndrome (Cushman \>7)
• Relative contraindications for high-intensity physical activities:

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Julie GIUSTINIANI, MD

  CHU Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine CHARRIERE, PhD

CONTACT

+ 33381218999; kcharriere@chu-besancon.fr

Magali NICOLIER, PhD

CONTACT

mnicolier@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: November 26, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)