Clinical trial NCT04451317: Physical Activity Following the Containment Period Imposed by the COVID-19 Pandemic in Patients
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
COVID-19
Keywords: anxiety
sleep
chronic pathology
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy athletes or patients involved in a Sport-health initiative

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient under the protection of adults (guardianship, curators), safeguard of justice),
* Pregnant and/or breastfeeding woman.

Primary outcomes:
measure: Physical activity measure
timeFrame: 1 day
Secondary outcomes:
measure: Depression
timeFrame: 1 day
measure: Sleep quality
timeFrame: 1 day
measure: food activity
timeFrame: 1 day
measure: activity level of chronic pathology
timeFrame: 1 day
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hopsital Toulouse
name: Fabien Pillard, MD
role: PRINCIPAL_INVESTIGATOR
References: