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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04399655
Acronym
NEPHRACTIVE
Enrollment
52
Registered
2020-05-22
Start date
2020-11-12
Completion date
2022-06-04
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure, Renal Insufficiency, Chronic

Brief 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.

Interventions

None listed

Sponsors

Clinique Néphrologique Saint-Exupéry
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Variation in direct and indirect medical coststhrough study completion, an average of 1 yearEvaluation 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.

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026