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Completed

NCT Number: NCT04451317

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

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.

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Key information

Conditions

Physical Activity Anxiety Disorders Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Motor Activity Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Strasbourg, Strasbourg, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire, phone call

Other

phone call and 3 questionnaires on a digital platform

Primary outcomes

  1. Physical activity measure

    Time frame: 1 day

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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.

Acronym: PhysiCOVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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