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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder

• Registration Number: NCT06706349
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study Start: 2024-10-17
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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:

  1. The participant agrees to hand over the keys to their vehicle if necessary.
  2. The keys will be returned when the blood alcohol level is below 0.25 mg/L
  3. 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)

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
• 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:
• Chronic respiratory insufficiency on long-term oxygen
• Severe chronic respiratory conditions
• Complicated diabetes with severe retinopathy
• Sickle cell disease
• Mild intoxication (psychoactive substances)
• Mild withdrawal syndrome (Cushman >2)
• Musculoskeletal and dermatological limitations: Unhealed traumatic injuries.
• Musculoskeletal and dermatological limitations: Osteoarticular conditions in acute flare (osteoarthritis, arthritis).
• Musculoskeletal and dermatological limitations: Diabetes with plantar ulcer.
• Musculoskeletal and dermatological limitations: Pressure ulcers and evolving or chronic wounds.
• On the day of signing consent: Blood alcohol concentration > 0 mg/L of expired air.
• On the day of signing consent: If blood alcohol concentration is < 0.25 mg/L, the participant may join other therapeutic activities and return home autonomously.
• On the day of signing consent: If blood alcohol concentration is > 0.25 mg/L without clinical signs of intoxication, the participant may join other therapeutic activities and return home accompanied.
• On the day of signing consent: If blood alcohol concentration is > 0.25 mg/L with clinical signs of intoxication, the participant will not join other therapeutic activities. A supervised room placement will be offered, and emergency services may be contacted if intoxication is unusually high (>2 g/L).
• Excessive alcohol consumption ≥ 6 days in the 4 weeks prior to inclusion.
• Average alcohol consumption > 20 g/day or > 100 g/week.
• CIWA score ≥ 9, indicating the need for medication-assisted withdrawal.
• High physical activity levels according to the Global Physical Activity Questionnaire (GPAQ).
• Concurrent treatment with disulfiram, acamprosate, benzodiazepines, topiramate, baclofen, naltrexone, nalmefene, melatonin, and beta-blockers.
• Unstable or recently changed treatments (<4 weeks).
• History of pre-delirium tremens or delirium tremens.
• Substance use disorder (other than alcohol/nicotine per DSM-5).
• Severe chronic psychiatric disorders (e.g., schizophrenia, paranoia, bipolar types I/II).
• Acute psychiatric disorders requiring immediate hospitalization or adjustment of psychotropic medications.
• Advanced somatic disorders contraindicating physical activity.
• Lack of signed automobile safety contract.
• Legal incapacity or refusal to sign consent.
• No health insurance.
• Anticipated poor cooperation or difficulty completing the study
• Pregnant or breastfeeding women.
• Currently in the exclusion period of another study or listed in the national volunteer registry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sleep duration measured by actigraphy.	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.	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).	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).	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).	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.	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.	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.	12 weeks.	Number of physical activity sessions completed by participants over the course of the study.
Sociodemographic characteristics collected at baseline.	Baseline only.	Collection of sociodemographic data including age, gender, marital status, education level, and employment status.
Previous adherence to physical activity.	Baseline only.	Participants' history of engagement in structured physical activity (binary: Yes/No).
Dropout rate during intervention.	12 weeks.	Proportion of participants who prematurely discontinued the study intervention.
Impact of personality traits on treatment adherence.	Baseline to 12 weeks.	Analysis of the relationship between personality traits (assessed by validated scales) and adherence to intervention protocols.

Secondary Outcome Measures

Name	Time	Method
Alcohol Consumption	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.
Direct Markers of Alcohol Use	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Biological markers directly indicating alcohol consumption.
Indirect Markers of Alcohol Use	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Biological markers indirectly indicating alcohol consumption.
Alcohol Dependence (ADS-Fr Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Alcohol dependence evaluated using the French version of the Alcohol Dependence Scale (ADS-Fr).
Alcohol Craving (OCDS Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Craving for alcohol assessed using the Obsessive-Compulsive Drinking Scale (OCDS)
Alcohol Craving (VAS Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Craving for alcohol assessed using Visual Analog Scales (VAS).
Impact of Craving Profile on Treatment Outcome	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Influence of the craving profile on treatment success analyzed using predefined criteria.
Risk of Transition to Compulsive Exercise (EDS-R Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Risk of developing compulsive exercise behaviors evaluated using the Exercise Dependence Scale-Revised (EDS-R).
Physical Capacity (Chair Stand Test)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Functional capacity assessed using the Chair Stand Test.
Physical Capacity (6-Minute Walk Test)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Functional capacity assessed using the 6-Minute Walk Test (6MWT).
Physical Activity Level (GPAQ Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Physical activity level measured using the Global Physical Activity Questionnaire (GPAQ).
Physical Activity Level (Physical Activity Calendar)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Physical activity patterns documented using a dedicated physical activity calendar.
Body Mass Index (BMI)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Calculated as weight in kilograms divided by the square of height in meters (kg/m²).
Waist Circumference (WC)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Measurement of waist circumference in centimeters.
Thigh Circumference (TC)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Measurement of thigh circumference in centimeters.
Blood Pressure (BP)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Pulse Rate	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Pulse rate measured in beats per minute (bpm).
Depression (QIDS Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Depression severity assessed using the Quick Inventory of Depressive Symptomatology (QIDS).
Anxiety (STAI Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Anxiety levels evaluated using the State-Trait Anxiety Inventory (STAI).
Impulsivity (UPPS-P Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Impulsive behaviors assessed using the UPPS-P Impulsive Behavior Scale.
Self-Esteem (Rosenberg Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Self-esteem assessed using the Rosenberg Self-Esteem Scale.
Quality of Life (WHOQOL-BREF Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Quality of life assessed using the WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire.
Decision-Making Abilities (MCQ-27 Score)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Decision-making abilities assessed using the Monetary Choice Questionnaire (MCQ-27).
Motivational Abilities (EEfRT Task)	Baseline, 6 weeks, 12 weeks, and 14 weeks.	Motivational abilities evaluated using the Effort Expenditure for Rewards Task (EEfRT) on a cycle ergometer.

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France