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CompletedNCT04399655NEPHRACTIVEUpdated Nov 16, 2022

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

An observational study in Chronic Renal Failure and Renal Insufficiency, Chronic, sponsored by Clinique Néphrologique Saint-Exupéry. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-16.

Sponsored by Clinique Néphrologique Saint-Exupéry · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
52
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Renal Failure
  • Renal Insufficiency, Chronic
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 52 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

This is the only study on the registry with Clinique Néphrologique Saint-Exupéry as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
52 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. change in the quality of life score

    Assessed by a The Short Form (36) (SF-36 scale) interpreted by an algorythm

    Time frame: baseline, at 6 months and at one year

  2. change in body mass index, weight and height will be combined to report BMI in kg/m^2

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  3. change in blood presure in mmHg

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  4. change in rate of haemoglobin in g/dL

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  5. change in percentage of hematocrit and saturation coefficient in %

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  6. change in rate of ferritin in ug/L

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  7. change in rate of urea, transferrin and blood sugar in g/L

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  8. change in rate of potassium in mEq/L

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  9. change in rate of bicarbonate in mmol/L

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  10. change in rate of calcium, phosphore and C-reactiv protein in mg/L

    obtained in start of hemodialysis session

    Time frame: every month, up to 12 months

  11. change in physical activity evaluation score, from 0 (better) to 20 (worse)

    obtained thanks to Borg scale

    Time frame: baseline, at 6 months and at one year

07

Study locations

1 site
  • Clinique Néphrologique Saint Saint-Exupéry
    Toulouse, 31077, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04399655
Lead sponsor
Clinique Néphrologique Saint-Exupéry
Responsible party
Sponsor
First posted
May 22, 2020
Start date
Nov 12, 2020
Primary completion
Jun 4, 2022
Completion
Jun 4, 2022
Last update
Nov 16, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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