AlcoholismACTP-ADDICTNCT04953403
Evaluation of Physical Activity of Patients Admitted to Addiction Service
An observational study of Alcoholism, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Addiction is a public health issue that affects nearly 30% of French people according to INSEE. For several years now, the investigators have known that sport is a real help in the fight against addictions, with recent medical authorization to prescribe physical activities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old
Who may be able to join
- Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old
Who cannot join
- Patient whose hospitalization is not related to addictology (accommodation, medical examination, etc.)
- Minor patient (age <18 years)
Trial locations and contacts
1 site in 1 country.
About this study
Addiction is a public health issue that affects nearly 30% of French people according to INSEE. For several years now, the investigators have known that sport is a real help in the fight against addictions, with recent medical authorization to prescribe physical activities. A study from August 2016 claims that regular physical activity may offset the harmful effects of alcohol. (1) Based on the answers given by 36,370 Britons between 1994 and 2006, the researchers showed the existence of a link between the practice of 150 minutes of physical activity per week and the decrease in deaths linked to consumption. alcohol. These results, compared to 18 other studies (2), reveal the benefits of physical activity in the management of addictions. But what about current practice and addictions and sports practice in general ?
- Conditions
- Alcoholism
- Keywords
- Psychoactive substances consumption, Physical activity, Alcohol withdrawal, Dependence level, Drug users
- Medical subject headings
- Alcoholism, Motor Activity, Drug Misuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal
Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal
Measured: 5 months
Assess the relationship between the level of physical activity of patients hospitalized for dependence on alcohol and tobacco
Assess the relationship between the level of physical activity of patients hospitalized for dependence on alcohol and tobacco
Measured: 5 months
level of physical activity of patients
level of physical activity of patients
Measured: 5 months
The relationship between the level of physical activity before the onset of dependence
The relationship between the level of physical activity before the onset of dependence
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jan 2020
- Primary completion30 May 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Donnadieu-Rigole, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953403
- Sponsor's protocol ID
- RECHMPL21_0374
- Acronym
- ACTP-ADDICT
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Activity of Patients Admitted to Addiction Service
- ClinicalTrials.gov ID
- NCT04953403
- Acronym / sponsor ID
- ACTP-ADDICT / RECHMPL21_0374
- Conditions
- Alcoholism
- Keywords
- Psychoactive substances consumption, Physical activity, Alcohol withdrawal, Dependence level, Drug users
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 8 Jul 2021 (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.
Addiction is a public health issue that affects nearly 30% of French people according to INSEE. For several years now, the investigators have known that sport is a real help in the fight against addictions, with recent medical authorization to prescribe physical activities. A study from August 2016 claims that regular physical activity may offset the harmful effects of alcohol. (1) Based on the answers given by 36,370 Britons between 1994 and 2006, the researchers showed the existence of a link between the practice of 150 minutes of physical activity per week and the decrease in deaths linked to consumption. alcohol. These results, compared to 18 other studies (2), reveal the benefits of physical activity in the management of addictions. But what about current practice and addictions and sports practice in general ?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old
Key inclusion criteria (1 listed)
- Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old
Key exclusion criteria (2 listed)
- Patient whose hospitalization is not related to addictology (accommodation, medical examination, etc.)
- Minor patient (age <18 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal
Time frame: 5 months
Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal
Assess the relationship between the level of physical activity of patients hospitalized for dependence on alcohol and tobacco
Time frame: 5 months
Assess the relationship between the level of physical activity of patients hospitalized for dependence on alcohol and tobacco
level of physical activity of patients
Time frame: 5 months
level of physical activity of patients
The relationship between the level of physical activity before the onset of dependence
Time frame: 5 months
The relationship between the level of physical activity before the onset of dependence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Hélène Donnadieu-Rigole, MD PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholism, run by University Hospital, Montpellier 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jul 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the relationship between the level of physical activity of patients hospitalized for drug addiction withdrawal (time frame: 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2021.