Cerebral Vascular DisorderQAP-AVCNCT03689387
Evaluation of Physical Activity Practice (AP) After Cerebral Vascular Stroke (Stroke)
An observational study of Cerebral Vascular Disorder, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Physical activity is defined by any movement produced by the skeletal muscles responsible for an increase in energy expenditure. The Stroke Council of the American Heart Association (AHA) recommends, in prevention after the occurrence of a first stroke, the practice of moderate to intense physical activity for 40… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vascular Disorder
- What is being tested?
- the Medical Program Information Systems (PMSI)
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2017to 23 Apr 2018
- 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: All other patients hospitalized in the department of Neurological MPR in the wake of a stroke, or who have been summoned to a post-stroke consultation by the Neurological MPR department of the University Hospital of Amiens, will initially be included.
Who may be able to join
- Patients over 18 years of age when completing the questionnaire.
- Have had ischemic or hemorrhagic stroke confirmed by MRI or CT scan.
- Hospitalized in the Department of Neurological MPR of Amiens University Hospital, or having received a consultation in MPR at Amiens University Hospital after returning home.
- Not institutionalized
Who cannot join
- Patients over 18 years of age when completing the questionnaire.
- Have had ischemic or hemorrhagic stroke confirmed by MRI or CT scan.
- Hospitalized in the Department of Neurological MPR of Amiens University Hospital, or having received a consultation in MPR at Amiens University Hospital after returning home.
- Not institutionalized
Trial locations and contacts
1 site in 1 country.
About this study
Physical activity is defined by any movement produced by the skeletal muscles responsible for an increase in energy expenditure.
The Stroke Council of the American Heart Association (AHA) recommends, in prevention after the occurrence of a first stroke, the practice of moderate to intense physical activity for 40 minutes a day, three to four times a week (Lackland et al., 2014). The World Health Organization (WHO) also recommends the practice of at least 150 minutes of moderate-intensity endurance activity or at least 75 minutes of endurance activity of sustained intensity per week, adapted to the possibilities of the patient (World Health Organization 2010). Unfortunately, the majority of stroke patients have activity below recommendation (Rand et al., 2009).
Read more
The main hypothesis of this work is that the amount of AP, measured by self-questionnaire, is insufficient, and below current recommendations in patients with stroke, after return home.
Given the multiple physical, psychological, social, and economic benefits of PA practice, it is also important to identify the habits and challenges that patients experience with PA, so that they can be better informed. advise and guide them to reach AP stroke recommendations.
Read the detailed description
Physical activity is defined by any movement produced by the skeletal muscles responsible for an increase in energy expenditure. It brings many benefits after stroke, particularly in terms of secondary prevention by reducing modifiable risk factors, cardio-respiratory capacity, and neuromotive, cognitive and functional recovery by stimulating brain plasticity (Saunders et al., 2014).
The Stroke Council of the American Heart Association (AHA) recommends, in prevention after the occurrence of a first stroke, the practice of moderate to intense physical activity for 40 minutes a day, three to four times a week (Lackland et al., 2014). The World Health Organization (WHO) also recommends the practice of at least 150 minutes of moderate-intensity endurance activity or at least 75 minutes of endurance activity of sustained intensity per week, adapted to the possibilities of the patient (World Health Organization 2010). Unfortunately, the majority of stroke patients have activity below recommendation (Rand et al., 2009).
The main hypothesis of this work is that the amount of AP, measured by self-questionnaire, is insufficient, and below current recommendations in patients with stroke, after return home.
Given the multiple physical, psychological, social, and economic benefits of PA practice, it is also important to identify the habits and challenges that patients experience with PA, so that they can be better informed. advise and guide them to reach AP stroke recommendations.
- Conditions
- Cerebral Vascular Disorder
- Being tested
- the Medical Program Information Systems (PMSI)
- Keywords
- cerebral vascular stroke, activity practice
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Medical Program Information Systems (PMSI)Other
The selection of the files will be carried out using the Medical Program Information Systems (PMSI) and search convocations for post-stroke follow-up consultations conducted by the Secretariat of Neurological MPR Amiens University Hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
AP in the aftermath of a stroke
The objective of this study is to Quantify the Physical Activity (PA) level to patients in the aftermath of a stroke after returning homeduring the rehabilitation treatment.
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start23 Oct 2017
- Primary completion23 Apr 2018
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Vascular DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Doutrellot, MD, PhD, Principal investigator, CHU AMIENS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689387
- Sponsor's protocol ID
- PI2017_843_0017
- Acronym
- QAP-AVC
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Activity Practice (AP) After Cerebral Vascular Stroke (Stroke)
- ClinicalTrials.gov ID
- NCT03689387
- Acronym / sponsor ID
- QAP-AVC / PI2017_843_0017
- Conditions
- Cerebral Vascular Disorder
- Keywords
- cerebral vascular stroke, activity practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 28 Sep 2018 (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.
Physical activity is defined by any movement produced by the skeletal muscles responsible for an increase in energy expenditure.
The Stroke Council of the American Heart Association (AHA) recommends, in prevention after the occurrence of a first stroke, the practice of moderate to intense physical activity for 40 minutes a day, three to four times a week (Lackland et al., 2014). The World Health Organization (WHO) also recommends the practice of at least 150 minutes of moderate-intensity endurance activity or at least 75 minutes of endurance activity of sustained intensity per week, adapted to the possibilities of the patient (World Health Organization 2010). Unfortunately, the majority of stroke patients have activity below recommendation (Rand et al., 2009).
The main hypothesis of this work is that the amount of AP, measured by self-questionnaire, is insufficient, and below current recommendations in patients with stroke, after return home.
Given the multiple physical, psychological, social, and economic benefits of PA practice, it is also important to identify the habits and challenges that patients experience with PA, so that they can be better informed. advise and guide them to reach AP stroke recommendations.
Detailed description
Physical activity is defined by any movement produced by the skeletal muscles responsible for an increase in energy expenditure. It brings many benefits after stroke, particularly in terms of secondary prevention by reducing modifiable risk factors, cardio-respiratory capacity, and neuromotive, cognitive and functional recovery by stimulating brain plasticity (Saunders et al., 2014).
The Stroke Council of the American Heart Association (AHA) recommends, in prevention after the occurrence of a first stroke, the practice of moderate to intense physical activity for 40 minutes a day, three to four times a week (Lackland et al., 2014). The World Health Organization (WHO) also recommends the practice of at least 150 minutes of moderate-intensity endurance activity or at least 75 minutes of endurance activity of sustained intensity per week, adapted to the possibilities of the patient (World Health Organization 2010). Unfortunately, the majority of stroke patients have activity below recommendation (Rand et al., 2009).
The main hypothesis of this work is that the amount of AP, measured by self-questionnaire, is insufficient, and below current recommendations in patients with stroke, after return home.
Given the multiple physical, psychological, social, and economic benefits of PA practice, it is also important to identify the habits and challenges that patients experience with PA, so that they can be better informed. advise and guide them to reach AP stroke recommendations.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All other patients hospitalized in the department of Neurological MPR in the wake of a stroke, or who have been summoned to a post-stroke consultation by the Neurological MPR department of the University Hospital of Amiens, will initially be included.
Key inclusion criteria (4 listed)
- Patients over 18 years of age when completing the questionnaire.
- Have had ischemic or hemorrhagic stroke confirmed by MRI or CT scan.
- Hospitalized in the Department of Neurological MPR of Amiens University Hospital, or having received a consultation in MPR at Amiens University Hospital after returning home.
- Not institutionalized
Key exclusion criteria (4 listed)
- Patients over 18 years of age when completing the questionnaire.
- Have had ischemic or hemorrhagic stroke confirmed by MRI or CT scan.
- Hospitalized in the Department of Neurological MPR of Amiens University Hospital, or having received a consultation in MPR at Amiens University Hospital after returning home.
- Not institutionalized
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 |
|---|---|---|
| the Medical Program Information Systems (PMSI)The selection of the files will be carried out using the Medical Program Information Systems (PMSI) and search convocations for post-stroke follow-up consultations conducted by the Secretariat of Neurological MPR Amiens University Hospital. | Other | – |
Primary outcome
AP in the aftermath of a stroke
Time frame: 36 month
The objective of this study is to Quantify the Physical Activity (PA) level to patients in the aftermath of a stroke after returning homeduring the rehabilitation treatment.
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 17 May 2023.
- 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. This study is not recruiting at the moment.
Louis Doutrellot, MD, PhD principal investigator
CHU AMIENS
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 Cerebral Vascular Disorder, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 4 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 17 May 2023. 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?
AP in the aftermath of a stroke (time frame: 36 month). 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 17 May 2023.