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

COVID-19 Clinical Trial

— PhysiCOVID  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04451317
• Other study ID #: RC31/20/0203
• Status: Completed
• Start date: June 12, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Physical Activity

Intervention

Other:
• Questionnaire, phone call
phone call and 3 questionnaires on a digital platform

Locations

Country	Name	City	State
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity measure	Changes in the level of physical activity (questionnaire from RICCI-GAGNON)	1 day
Secondary	Depression	To evaluate the f the level of anxiety and depression by questionnaire HAD	1 day
Secondary	Sleep quality	To evaluate the level of sleep activity by questionnaire LEEDS	1 day
Secondary	food activity	To evaluate the food activity by questionnaire LEEDS	1 day
Secondary	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	1 day