Impact of Physical Activity on Patients With Chronic Kidney Disease Not Receiving Dialysis Followed in the TIRCEL Network. An Exposed / Unexposed Study (PHYSALYS)

PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups: patients exposed to physical activity and unexposed. The main objective of the study is to compare the evolution of glomerular filtration rate at inclusion and 12 months later between patients practicing physical activity and patients not practicing. If necessary, the renal disease-related complications, which are not influenced by physical activity: (type of kidney disease, age and tobacco), would be taken into account. TIRCEL patients with chronic kidney disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum creatinine data, 12 months prior to inclusion, is collected retrospectively. Patients are followed in the trial during 12 months. To evaluate physical activity, patients respond to Global Physical Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During this 12 months period, the same biological data are collected prospectively.

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Key information

Conditions

Renal Insufficiency, Chronic Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Members of TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for over a year and having at least two measurements of glomerular filtration rate with an interval of 9 to 12 months between the first and the last measurement
Patients in stages 3, 4 or 5 of CKD
No dialysis CKD patients
Non transplanted CKD patients
Patients seeing nephrologist
Patients agreeing to be contacted for a phone call half an hour
Adults patients (> 18 years)
Patients not living in institution
Patients being able to answer a questionnaire

Exclusion criteria

Patients followed in the TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for less than one year or having less than 2 measurements of glomerular filtration rate with an interval of least 9 months or over 12 months between the first and the last measurement
Patients in stages 1 or 2 of CKD
CKD patients receiving dialysis
Transplanted CKD patients
Patients not seeing nephrologist
Patients refusing to be contacted for a phone call half an hour
Patients < 18 years
Patients living in institution
Patients unable to answer a questionnaire

Treatment and study plan

Global Physical Activity Questionnaire

Other

The practice of physical activity is measured by the GPAQ 2 questionnaire (Global Physical Activity Questionnaire) developed by the World Health Organization.

Primary outcomes

Change of the Glomerular Filtration Rate (GFR)

Time frame: Month 0, Month 12

The Glomerular Filtration Rate (GFR) annual slope between inclusion (M0) and 12 months (M12) after inclusion in exposed and unexposed groups.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PHYSALYS

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jun 29, 2016
Registry last updated: Jun 29, 2016

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.

Published trials that share one or more normalized conditions with this study.

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