Clinical trial NCT06706349: Effect of Adapted Physical Activity on Sleep Quality in People with Alcohol Use Disorder
Official title: Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep duration measured by actigraphy.
timeFrame: Baseline, 6 weeks (midpoint), 12 weeks (end of sessions), and 14 weeks (2 weeks post-intervention)
measure: Circadian parameters measured by urinary melatonin levels.
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks
measure: Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Insomnia severity measured by Insomnia Severity Index (ISI).
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS).
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Sleep-wake patterns measured by sleep diary.
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Morningness-eveningness preferences measured by Horne and Östberg Scale.
timeFrame: Baseline only.
measure: Adherence to treatment measured by completed APA sessions.
timeFrame: 12 weeks.
measure: Sociodemographic characteristics collected at baseline.
timeFrame: Baseline only.
measure: Previous adherence to physical activity.
timeFrame: Baseline only.
measure: Dropout rate during intervention.
timeFrame: 12 weeks.
measure: Impact of personality traits on treatment adherence.
timeFrame: Baseline to 12 weeks.
Secondary outcomes:
measure: Alcohol Consumption
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Direct Markers of Alcohol Use
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Indirect Markers of Alcohol Use
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Alcohol Dependence (ADS-Fr Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Alcohol Craving (OCDS Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Alcohol Craving (VAS Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Impact of Craving Profile on Treatment Outcome
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Risk of Transition to Compulsive Exercise (EDS-R Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Physical Capacity (Chair Stand Test)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Physical Capacity (6-Minute Walk Test)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Physical Activity Level (GPAQ Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Physical Activity Level (Physical Activity Calendar)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Body Mass Index (BMI)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Waist Circumference (WC)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Thigh Circumference (TC)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Blood Pressure (BP)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Pulse Rate
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Depression (QIDS Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Anxiety (STAI Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Impulsivity (UPPS-P Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Self-Esteem (Rosenberg Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Quality of Life (WHOQOL-BREF Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Decision-Making Abilities (MCQ-27 Score)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
measure: Motivational Abilities (EEfRT Task)
timeFrame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU Besançon
name: Julie GIUSTINIANI, MD
role: PRINCIPAL_INVESTIGATOR
References: