Alcohol Use DisorderAPhysOHNCT06706349
Effect of Adapted Physical Activity on Sleep Quality in People With Alcohol Use Disorder
A study testing APA managed by qualified instructor and Autonomous APA in people with Alcohol Use Disorder, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- APA managed by qualified instructor and Autonomous APA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- Decompensated heart failure
- Complex ventricular arrhythmias
- Severe uncontrolled hypertension
- Pulmonary hypertension (>60 mmHg)
- Myocarditis or acute pericardial effusion
- Severe obstructive cardiomyopathy
Show all 45Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Magali NICOLIER, PhD contact
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25000
Lilou DUQUET, PhD student, lilou.duquet@edu.univ-fcomte.fr
Karine Charrière, PhD, kcharriere@chu-besancon.fr
About this study
Official title: Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder
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
- Being tested
- APA managed by qualified instructor, Autonomous APA
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APA managed by qualified instructorBehavioural
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.
Autonomous APABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Managed adapted physical activity | Experimental | Participants will receive 3 weekly sessions of supervised adapted physical activity (APA) starting from Visit 3. Receives: 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. Receives: Behavioral: Autonomous APA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration measured by actigraphy.
Objective measurement of sleep duration (in minutes) using actigraphy over the course of the study.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline only.
Adherence to treatment measured by completed APA sessions.
Number of physical activity sessions completed by participants over the course of the study.
Measured: 12 weeks.
Sociodemographic characteristics collected at baseline.
Collection of sociodemographic data including age, gender, marital status, education level, and employment status.
Measured: Baseline only.
Previous adherence to physical activity.
Participants' history of engagement in structured physical activity (binary: Yes/No).
Measured: Baseline only.
Dropout rate during intervention.
Proportion of participants who prematurely discontinued the study intervention.
Measured: 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.
Measured: Baseline to 12 weeks.
Secondary outcomes (24)
Alcohol Consumption
Daily alcohol consumption reported in standard units (equivalent to 10g of alcohol) using the Timeline Follow Back (TLFB) method.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Direct Markers of Alcohol Use
Biological markers directly indicating alcohol consumption.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Indirect Markers of Alcohol Use
Biological markers indirectly indicating alcohol consumption.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Dependence (ADS-Fr Score)
Alcohol dependence evaluated using the French version of the Alcohol Dependence Scale (ADS-Fr).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Craving (OCDS Score)
Craving for alcohol assessed using the Obsessive-Compulsive Drinking Scale (OCDS)
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Craving (VAS Score)
Craving for alcohol assessed using Visual Analog Scales (VAS).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Impact of Craving Profile on Treatment Outcome
Influence of the craving profile on treatment success analyzed using predefined criteria.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Risk of Transition to Compulsive Exercise (EDS-R Score)
Risk of developing compulsive exercise behaviors evaluated using the Exercise Dependence Scale-Revised (EDS-R).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Capacity (Chair Stand Test)
Functional capacity assessed using the Chair Stand Test.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Capacity (6-Minute Walk Test)
Functional capacity assessed using the 6-Minute Walk Test (6MWT).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Activity Level (GPAQ Score)
Physical activity level measured using the Global Physical Activity Questionnaire (GPAQ).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Activity Level (Physical Activity Calendar)
Physical activity patterns documented using a dedicated physical activity calendar.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Body Mass Index (BMI)
Calculated as weight in kilograms divided by the square of height in meters (kg/m²).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Waist Circumference (WC)
Measurement of waist circumference in centimeters.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Thigh Circumference (TC)
Measurement of thigh circumference in centimeters.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Blood Pressure (BP)
Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Pulse Rate
Pulse rate measured in beats per minute (bpm).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Depression (QIDS Score)
Depression severity assessed using the Quick Inventory of Depressive Symptomatology (QIDS).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Anxiety (STAI Score)
Anxiety levels evaluated using the State-Trait Anxiety Inventory (STAI).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Impulsivity (UPPS-P Score)
Impulsive behaviors assessed using the UPPS-P Impulsive Behavior Scale.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Self-Esteem (Rosenberg Score)
Self-esteem assessed using the Rosenberg Self-Esteem Scale.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Quality of Life (WHOQOL-BREF Score)
Quality of life assessed using the WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Decision-Making Abilities (MCQ-27 Score)
Decision-making abilities assessed using the Monetary Choice Questionnaire (MCQ-27).
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Motivational Abilities (EEfRT Task)
Motivational abilities evaluated using the Effort Expenditure for Rewards Task (EEfRT) on a cycle ergometer.
Measured: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start17 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie GIUSTINIANI, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706349
- Sponsor's protocol ID
- 2024/863
- Acronym
- APhysOH
- Status last verified
- Nov 2025
- First submitted
- 4 Sep 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42288917
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder
- ClinicalTrials.gov ID
- NCT06706349
- Acronym / sponsor ID
- APhysOH / 2024/863
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Managed adapted physical activity | Experimental | Behavioral: APA managed by qualified instructorParticipants will receive 3 weekly sessions of supervised adapted physical activity (APA) starting from Visit 3. |
| Autonomous adapted physical activity | Placebo comparator | Behavioral: Autonomous APAParticipants in this arm will receive a leaflet summarizing WHO recommendations on physical activity at the start of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (45 listed)
- Decompensated heart failure
- Complex ventricular arrhythmias
- Severe uncontrolled hypertension
- Pulmonary hypertension (>60 mmHg)
- Myocarditis or acute pericardial effusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APA managed by qualified instructorEach 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. | Behavioural | Managed adapted physical activity |
| Autonomous APAA 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. | Behavioural | Autonomous adapted physical activity |
Primary outcome
Sleep duration measured by actigraphy.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks.
Number of physical activity sessions completed by participants over the course of the study.
Sociodemographic characteristics collected at baseline.
Time frame: Baseline only.
Collection of sociodemographic data including age, gender, marital status, education level, and employment status.
Previous adherence to physical activity.
Time frame: Baseline only.
Participants' history of engagement in structured physical activity (binary: Yes/No).
Dropout rate during intervention.
Time frame: 12 weeks.
Proportion of participants who prematurely discontinued the study intervention.
Impact of personality traits on treatment adherence.
Time frame: Baseline to 12 weeks.
Analysis of the relationship between personality traits (assessed by validated scales) and adherence to intervention protocols.
24 secondary outcomes
Alcohol Consumption
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Direct Markers of Alcohol Use
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Indirect Markers of Alcohol Use
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Dependence (ADS-Fr Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Craving (OCDS Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Alcohol Craving (VAS Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Impact of Craving Profile on Treatment Outcome
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Risk of Transition to Compulsive Exercise (EDS-R Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Capacity (Chair Stand Test)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Capacity (6-Minute Walk Test)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Activity Level (GPAQ Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Physical Activity Level (Physical Activity Calendar)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Body Mass Index (BMI)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Waist Circumference (WC)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Thigh Circumference (TC)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Blood Pressure (BP)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Pulse Rate
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Depression (QIDS Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Anxiety (STAI Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Impulsivity (UPPS-P Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Self-Esteem (Rosenberg Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Quality of Life (WHOQOL-BREF Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Decision-Making Abilities (MCQ-27 Score)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Motivational Abilities (EEfRT Task)
Time frame: Baseline, 6 weeks, 12 weeks, and 14 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 42288917Duquet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magali NICOLIER, PhD contact
Julie GIUSTINIANI, MD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA managed by qualified instructor and Autonomous APA in people with Alcohol Use Disorder, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine CHARRIERE, PhD (+ 33381218999, kcharriere@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration measured by actigraphy. (time frame: Baseline, 6 weeks (midpoint), 12 weeks (end of sessions), and 14 weeks (2 weeks post-intervention)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06706349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.