Physical Activity Following the Containment Period Imposed by the COVID-19 Pandemic in Patients

NCT ID: NCT04451317

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 499 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2020-12-31

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.

Conditions

Physical Activity; COVID-19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Questionnaire, phone call

Intervention Type: OTHER

phone call and 3 questionnaires on a digital platform

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.

Questionnaire, phone call

Intervention Type: OTHER

phone call and 3 questionnaires on a digital platform

Interventions

Questionnaire, phone call

phone call and 3 questionnaires on a digital platform

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabien Pillard, MD

Role: PRINCIPAL_INVESTIGATOR

University Hopsital Toulouse

Locations

CHU Strasbourg

Strasbourg, , France

CHU Toulouse

Toulouse, , France

Countries

France

Other Identifiers

RC31/20/0203

Identifier Type: -

Identifier Source: org_study_id