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

Renal Insufficiency, Chronic Clinical Trial

— NEPHRACTIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399655
• Other study ID #: 01/2020
• Secondary ID: 2020-A00209-30
• Status: Completed
• Start date: November 12, 2020
• Est. completion date: June 4, 2022

Study information

• Verified date: June 2022
• Source: Clinique Néphrologique Saint-Exupéry
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 4, 2022
• Est. primary completion date: June 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
France	Clinique Néphrologique Saint Saint-Exupéry	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Néphrologique Saint-Exupéry

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	change in blood presure in mmHg	obtained in start of hemodialysis session	every month, up to 12 months
Secondary	change in rate of haemoglobin in g/dL	obtained in start of hemodialysis session	every month, up to 12 months
Secondary	change in percentage of hematocrit and saturation coefficient in %	obtained in start of hemodialysis session	every month, up to 12 months
Secondary	change in rate of ferritin in ug/L	obtained in start of hemodialysis session	every month, up to 12 months
Secondary	change in rate of urea, transferrin and blood sugar in g/L	obtained in start of hemodialysis session	every month, up to 12 months
Secondary	change in rate of potassium in mEq/L	obtained in start of hemodialysis session	every month, up to 12 months
Secondary	change in rate of bicarbonate in mmol/L	obtained in start of hemodialysis session	every month, up to 12 months
Secondary	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
Secondary	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