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

NCT04399655 | Completed

• 2 other identifiers: 01/20202020-A00209-30
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure; Renal Insufficiency, Chronic

Outcome Measures

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.

  through study completion, an average of 1 year

Secondary Outcomes (11)

• change in the quality of life score

  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

  every month, up to 12 months

• change in blood presure in mmHg

  every month, up to 12 months

• change in rate of haemoglobin in g/dL

  every month, up to 12 months

• change in percentage of hematocrit and saturation coefficient in %

  every month, up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Clinique Néphrologique Saint-Exupéry: lead

Study Sites (1)

Clinique Néphrologique Saint Saint-Exupéry

Toulouse, 31077, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 22, 2020
• Study Start: November 12, 2020
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-06

Locations

FR (1)