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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT04451317
Collaborator
(none)
499
2
6.6
249.5
37.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire, phone call

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

Study Type:
Observational
Actual Enrollment :
499 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Actual Study Start Date :
Jun 12, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Questionnaire, phone call
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.

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

Outcome Measures

Primary Outcome Measures

  1. Physical activity measure [1 day]

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

Secondary Outcome Measures

  1. Depression [1 day]

    To evaluate the f the level of anxiety and depression by questionnaire HAD

  2. Sleep quality [1 day]

    To evaluate the level of sleep activity by questionnaire LEEDS

  3. food activity [1 day]

    To evaluate the food activity by questionnaire LEEDS

  4. activity level of chronic pathology [1 day]

    To evaluate of the activity level of chronic pathology (monitoring criteria in accordance with good clinical practice) in patients with chronic pathology by questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Strasbourg Strasbourg France
2 CHU Toulouse Toulouse France 31000

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Fabien Pillard, MD, University Hopsital Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04451317
Other Study ID Numbers:
  • RC31/20/0203
First Posted:
Jun 30, 2020
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022