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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451317
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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
Physical Activity COVID-19 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.

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Study Type : Observational
Estimated Enrollment : 600 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.
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Physical activity measure [ Time Frame: 1 day ]
    Changes in the level of physical activity (questionnaire from RICCI-GAGNON)


Secondary Outcome Measures :
  1. Depression [ Time Frame: 1 day ]
    To evaluate the f the level of anxiety and depression by questionnaire HAD

  2. Sleep quality [ Time Frame: 1 day ]
    To evaluate the level of sleep activity by questionnaire LEEDS

  3. food activity [ Time Frame: 1 day ]
    To evaluate the food activity by questionnaire LEEDS

  4. activity level of chronic pathology [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
healthy athletes or patients involved in a Sport-health initiative
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451317


Contacts
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Contact: Fabien Pillard, MD (+33)5.61.77.61.71 Pillard.f@chu-toulouse.fr

Locations
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France
CHU Toulouse
Toulouse, France, 31000
Contact: Fabien PILLARD    561776171 ext +33      
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Fabien Pillard, MD University Hopsital Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04451317    
Other Study ID Numbers: RC31/20/0203
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
anxiety
sleep
chronic pathology