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Clinical Trials/NCT04451317
NCT04451317
Completed
Not Applicable

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.

University Hospital, Toulouse2 sites in 1 country499 target enrollmentJune 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University Hospital, Toulouse
Enrollment
499
Locations
2
Primary Endpoint
Physical activity measure
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2020
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Physical activity measure

Time Frame: 1 day

Changes in the level of physical activity (questionnaire from RICCI-GAGNON)

Secondary Outcomes

  • Depression(1 day)
  • Sleep quality(1 day)
  • activity level of chronic pathology(1 day)
  • food activity(1 day)

Study Sites (2)

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