Physical ActivityPhysiCOVIDNCT04451317
Physical Activity Following the Containment Period Imposed by the COVID-19 Pandemic in Patients
An observational study of Physical Activity and COVID-19, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
In the context of the containment imposed by the COVID-19 pandemic and taking into account the numerous restrictions imposed, the practice of physical and sports activities (PSA) could be reduced by general population and sports population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, COVID-19
- What is being tested?
- Questionnaire, phone call
- How many people
- 499 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jun 2020to 31 Dec 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
- Adult, Older adult
Study population: healthy athletes or patients involved in a Sport-health initiative
Who may be able to join
- non-working or tele-working subjects, subjects who have returned to work, subjects who have taken up a part-time professional activity, subjects who have resumed an activity full-time professional
- subjects who have given their consent
- for the sports topics group: amateur level (no sportsmen and women professionals), including sports subjects in the disabled category, with no chronic pathology, already followed by the investigating medical units.
- for the group of patients with chronic diseases: subjects carrying a chronic pathology (rheumatic pathologies, etc) and fibromyalgia, Parkinson's disease and multiple sclerosis, cancer of the breast, metabolic diseases without cardiovascular failure) usually accompanied by the medical units for the implementation of a programme of physic adapted and medically prescribed (Sport-Santé approach)
- social security affiliation
Who cannot join
- Patient under the protection of adults (guardianship, curators), safeguard of justice),
- Pregnant and/or breastfeeding woman.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Changes in Physical and Sports Activity, Anxiety and Sleep Patterns Following the Containment Period Imposed by the COVID-19 Pandemic in Patients With Chronic Medical Conditions and in Healthy Athletes.
In the context of the containment imposed by the COVID-19 pandemic and taking into account the numerous restrictions imposed, the practice of physical and sports activities (PSA) could be reduced by general population and sports population. While the practice of regular physical activity (PA) is prescribed and widely recognized as effective for the management of many chronic conditions and that regular participation in sports (SA) reduces the risk of injury and cardiac accidents- vascular disease in sports subjects, the reduction in regular physical activity levels in the wake of the period of confinement is likely to induce a medical risk in connection with the resumption of PSA.
Read the detailed description
The study is non-interventional. The data that will be collected are data that can be integrated into a care procedure in accordance with the recommendations to accompany the patients with chronic pathology and athletes for the resumption of PSA after hypothetical deconditioning. Support will be implemented in accordance with the recommendations of the HCSP and the Ministry of Sports. The objective of this study is to evaluate the data of this recommended medical follow-up.
The questionnaires used for the subjects' self-evaluation are all validated in French language, used in the context of medical monitoring, and used in clinical research: assessment of physical activity levels by the questionnaire of RICCI and GAGNON (RG), evaluation of the level of Anxiety and Depression by the Hospital and Anxiety Scale Depression (AHH), assessment of sleep quality by the score of LEEDS.
Medical questionnaires to assess the evolutionary stage of chronic pathologies (MS, Parkinson's disease and Fibromyalgia) will be informed by the investigating physician during the interview telephone with the patient.
- Conditions
- Physical Activity, COVID-19
- Being tested
- Questionnaire, phone call
- Keywords
- anxiety, sleep, chronic pathology
- Medical subject headings
- Motor Activity, COVID-19, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire, phone callOther
phone call and 3 questionnaires on a digital platform
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients involved in a Sport-Health initiative Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview. Receives: Other: Questionnaire, phone call | |
| Control | Healthy sport subjects. Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview. Receives: Other: Questionnaire, phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measure
Changes in the level of physical activity (questionnaire from RICCI-GAGNON)
Measured: 1 day
Secondary outcomes (4)
Depression
To evaluate the f the level of anxiety and depression by questionnaire HAD
Measured: 1 day
Sleep quality
To evaluate the level of sleep activity by questionnaire LEEDS
Measured: 1 day
food activity
To evaluate the food activity by questionnaire LEEDS
Measured: 1 day
activity level of chronic pathology
To evaluate of the activity level of chronic pathology (monitoring criteria in accordance with good clinical practice) in patients with chronic pathology by questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start12 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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-control
- Time perspective
- Prospective
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien Pillard, MD, Principal investigator, University Hopsital Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451317
- Sponsor's protocol ID
- RC31/20/0203
- Acronym
- PhysiCOVID
- Status last verified
- Mar 2022
- First submitted
- 26 Jun 2020
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Physical and Sports Activity, Anxiety and Sleep Patterns Following the Containment Period Imposed by the COVID-19 Pandemic in Patients With Chronic Medical Conditions and in Healthy Athletes.
- ClinicalTrials.gov ID
- NCT04451317
- Acronym / sponsor ID
- PhysiCOVID / RC31/20/0203
- Conditions
- Physical Activity, COVID-19
- Keywords
- anxiety, sleep, chronic pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Jun 2020 (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.
In the context of the containment imposed by the COVID-19 pandemic and taking into account the numerous restrictions imposed, the practice of physical and sports activities (PSA) could be reduced by general population and sports population. While the practice of regular physical activity (PA) is prescribed and widely recognized as effective for the management of many chronic conditions and that regular participation in sports (SA) reduces the risk of injury and cardiac accidents- vascular disease in sports subjects, the reduction in regular physical activity levels in the wake of the period of confinement is likely to induce a medical risk in connection with the resumption of PSA.
Detailed description
The study is non-interventional. The data that will be collected are data that can be integrated into a care procedure in accordance with the recommendations to accompany the patients with chronic pathology and athletes for the resumption of PSA after hypothetical deconditioning. Support will be implemented in accordance with the recommendations of the HCSP and the Ministry of Sports. The objective of this study is to evaluate the data of this recommended medical follow-up.
The questionnaires used for the subjects' self-evaluation are all validated in French language, used in the context of medical monitoring, and used in clinical research: assessment of physical activity levels by the questionnaire of RICCI and GAGNON (RG), evaluation of the level of Anxiety and Depression by the Hospital and Anxiety Scale Depression (AHH), assessment of sleep quality by the score of LEEDS.
Medical questionnaires to assess the evolutionary stage of chronic pathologies (MS, Parkinson's disease and Fibromyalgia) will be informed by the investigating physician during the interview telephone with the patient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Questionnaire, phone callPatients involved in a Sport-Health initiative Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview. |
| Control | – | Other: Questionnaire, phone callHealthy sport subjects. Visit once by telephone and then ask to fill in 3 questionnaires on a digital platform within 48 hours after the telephone interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- healthy athletes or patients involved in a Sport-health initiative
Key inclusion criteria (5 listed)
- non-working or tele-working subjects, subjects who have returned to work, subjects who have taken up a part-time professional activity, subjects who have resumed an activity full-time professional
- subjects who have given their consent
- for the sports topics group: amateur level (no sportsmen and women professionals), including sports subjects in the disabled category, with no chronic pathology, already followed by the investigating medical units.
- for the group of patients with chronic diseases: subjects carrying a chronic pathology (rheumatic pathologies, etc) and fibromyalgia, Parkinson's disease and multiple sclerosis, cancer of the breast, metabolic diseases without cardiovascular failure) usually accompanied by the medical units for the implementation of a programme of physic adapted and medically prescribed (Sport-Santé approach)
- social security affiliation
Key exclusion criteria (2 listed)
- Patient under the protection of adults (guardianship, curators), safeguard of justice),
- Pregnant and/or breastfeeding woman.
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 |
|---|---|---|
| Questionnaire, phone callphone call and 3 questionnaires on a digital platform | Other | Control, Experimental |
Primary outcome
Physical activity measure
Time frame: 1 day
Changes in the level of physical activity (questionnaire from RICCI-GAGNON)
4 secondary outcomes
Depression
Time frame: 1 day
Sleep quality
Time frame: 1 day
food activity
Time frame: 1 day
activity level of chronic pathology
Time frame: 1 day
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 16 Mar 2022.
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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.
Fabien Pillard, MD principal investigator
University Hopsital Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity and COVID-19, run by University Hospital, Toulouse at 2 sites 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 5 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Physical activity measure (time frame: 1 day). 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 16 Mar 2022.