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

Renal Insufficiency, Chronic Clinical Trial

— PHYSALYS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818010
• Other study ID #: D50806
• Status: Completed
• Phase: N/A
• First received: June 21, 2016
• Last updated: June 28, 2016
• Start date: May 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the Glomerular Filtration Rate (GFR)	The Glomerular Filtration Rate (GFR) annual slope between inclusion (M0) and 12 months (M12) after inclusion in exposed and unexposed groups.	Month 0, Month 12	No