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

Официальное название

Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder

Обзор

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.

Вмешательства

• Поведенческое APA managed by qualified instructor
  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-m
• Поведенческое Autonomous APA
  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.

Первичные конечные точки

• Sleep duration measured by actigraphy. [Срок оценки: Baseline, 6 weeks (midpoint), 12 weeks (end of sessions), and 14 weeks (2 weeks post-intervention)]
• Circadian parameters measured by urinary melatonin levels. [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks]
• Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI). [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Insomnia severity measured by Insomnia Severity Index (ISI). [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Daytime sleepiness assessed by Epworth Sleepiness Scale (ESS). [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Sleep-wake patterns measured by sleep diary. [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Morningness-eveningness preferences measured by Horne and Östberg Scale. [Срок оценки: Baseline only.]
• Adherence to treatment measured by completed APA sessions. [Срок оценки: 12 weeks.]
• Sociodemographic characteristics collected at baseline. [Срок оценки: Baseline only.]
• Previous adherence to physical activity. [Срок оценки: Baseline only.]

Вторичные конечные точки (12)

• Alcohol Consumption [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Direct Markers of Alcohol Use [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Indirect Markers of Alcohol Use [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Alcohol Dependence (ADS-Fr Score) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Alcohol Craving (OCDS Score) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Alcohol Craving (VAS Score) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Impact of Craving Profile on Treatment Outcome [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Risk of Transition to Compulsive Exercise (EDS-R Score) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Physical Capacity (Chair Stand Test) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Physical Capacity (6-Minute Walk Test) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Physical Activity Level (GPAQ Score) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]
• Physical Activity Level (Physical Activity Calendar) [Срок оценки: Baseline, 6 weeks, 12 weeks, and 14 weeks.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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, 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).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• CHU de Besançon — Besançon

Публикации

• Duquet L, Boitel A, Galli S, Charriere K, Mauny F, Haffen E, Giustiniani J. Physical activity and sleep disturbances in individuals with alcohol use disorder: protocol of the APhysOH pilot study for a randomized controlled trial. Addict Sci Clin Pract. 2026 Jun 13. doi: 10.1186/s13722-026-00683-1. Online ahead of print. PMID 42288917

Идентификаторы

NCT: NCT06706349 · 2024/863

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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