Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sleep duration measured by actigraphy.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Managed adapted physical activity
Participants will receive 3 weekly sessions of supervised adapted physical activity (APA) starting from Visit 3.
干预措施: APA managed by qualified instructor (Behavioral)
Autonomous adapted physical activity
Participants in this arm will receive a leaflet summarizing WHO recommendations on physical activity at the start of the study.
干预措施: Autonomous APA (Behavioral)
结局指标
主要结局
Sleep duration measured by actigraphy.
时间窗: 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.
时间窗: 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).
时间窗: 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).
时间窗: 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).
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 12 weeks.
Number of physical activity sessions completed by participants over the course of the study.
Sociodemographic characteristics collected at baseline.
时间窗: Baseline only.
Collection of sociodemographic data including age, gender, marital status, education level, and employment status.
Previous adherence to physical activity.
时间窗: Baseline only.
Participants' history of engagement in structured physical activity (binary: Yes/No).
Dropout rate during intervention.
时间窗: 12 weeks.
Proportion of participants who prematurely discontinued the study intervention.
Impact of personality traits on treatment adherence.
时间窗: Baseline to 12 weeks.
Analysis of the relationship between personality traits (assessed by validated scales) and adherence to intervention protocols.
次要结局
- 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.)
- Alcohol Craving (VAS Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Impact of Craving Profile on Treatment Outcome(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Risk of Transition to Compulsive Exercise (EDS-R Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Capacity (Chair Stand Test)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Capacity (6-Minute Walk Test)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Activity Level (GPAQ Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Physical Activity Level (Physical Activity Calendar)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Body Mass Index (BMI)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Waist Circumference (WC)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Thigh Circumference (TC)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Blood Pressure (BP)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Pulse Rate(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Depression (QIDS Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Anxiety (STAI Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Impulsivity (UPPS-P Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Self-Esteem (Rosenberg Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Quality of Life (WHOQOL-BREF Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Decision-Making Abilities (MCQ-27 Score)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)
- Motivational Abilities (EEfRT Task)(Baseline, 6 weeks, 12 weeks, and 14 weeks.)