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Completed

NCT Number: NCT04399655

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

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.

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Néphrologique Saint Saint-Exupéry

Toulouse, 31077, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Variation in direct and indirect medical costs

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

    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.

Secondary outcomes

  1. change in the quality of life score

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

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

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

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

  3. change in blood presure in mmHg

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

  4. change in rate of haemoglobin in g/dL

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

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

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

  6. change in rate of ferritin in ug/L

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

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

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

  8. change in rate of potassium in mEq/L

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

  9. change in rate of bicarbonate in mmol/L

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

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

    Time frame: every month, up to 12 months

    obtained in start of hemodialysis session

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

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

    obtained thanks to Borg scale

Sponsors and collaborators

Lead sponsor

Clinique Néphrologique Saint-Exupéry

Other

Registry information

Acronym: NEPHRACTIVE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 22, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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