Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients (NEPHRACTIVE)

Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.

Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.

Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.

Nevertheless, there are no data on the medico-economic impact of such a program.

Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.

The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Chronic Renal Failure

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31077
    • Clinique Néphrologique Saint Saint-Exupéry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Haemodialysis patient, of full age, for more than 12 months and in front of benefiting/benefiting from a physical activity program

Description

Inclusion Criteria:

• Patient dependent on the CPAM Haute Garonne,
• Patient affiliated to or beneficiary of a French social security scheme,
• Haemodialysis patient for more than 12 months and in front of benefiting/benefiting from a physical activity program,
• Patient age ≥ at 18 years old,
• French speaking patient.

Exclusion Criteria:

• Patient with cancer, hepatitis, stage 4 arterial disease, arteritis or amputation of a limb
• Pregnant or breastfeeding women according to article L.1121-5 of the CSP,
• Vulnerable persons according to article L.1121-6 of the CSP,
• Persons of full age under guardianship or curatorship or under safeguard of justice,
• Patient unable to personally give his or her consent, or age of majority protected by law,
• Opposition expressed to inclusion in the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation in direct and indirect medical costs	Evaluation of medical costs between the 12 months prior to the start of the adapted physical activity program and the 12 months following the start of the adapted physical activity program.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the quality of life score	Assessed by a The Short Form (36) (SF-36 scale) interpreted by an algorythm	baseline, at 6 months and at one year
change in body mass index, weight and height will be combined to report BMI in kg/m^2	obtained in start of hemodialysis session	every month, up to 12 months
change in blood presure in mmHg	obtained in start of hemodialysis session	every month, up to 12 months
change in rate of haemoglobin in g/dL	obtained in start of hemodialysis session	every month, up to 12 months
change in percentage of hematocrit and saturation coefficient in %	obtained in start of hemodialysis session	every month, up to 12 months
change in rate of ferritin in ug/L	obtained in start of hemodialysis session	every month, up to 12 months
change in rate of urea, transferrin and blood sugar in g/L	obtained in start of hemodialysis session	every month, up to 12 months
change in rate of potassium in mEq/L	obtained in start of hemodialysis session	every month, up to 12 months
change in rate of bicarbonate in mmol/L	obtained in start of hemodialysis session	every month, up to 12 months
change in rate of calcium, phosphore and C-reactiv protein in mg/L	obtained in start of hemodialysis session	every month, up to 12 months
change in physical activity evaluation score, from 0 (better) to 20 (worse)	obtained thanks to Borg scale	baseline, at 6 months and at one year

Collaborators and Investigators

• Sponsor: Clinique Néphrologique Saint-Exupéry

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2020
• Primary Completion (ACTUAL): June 4, 2022
• Study Completion (ACTUAL): June 4, 2022

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (ACTUAL): May 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 01/2020; 2020-A00209-30 (OTHER: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No