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Contribution of Per Dialytic Physical Activity in Chronic Dialysis Patients

Not Applicable
Recruiting
Conditions
Dialysis
Interventions
Other: physical activity
Registration Number
NCT06471283
Lead Sponsor
Centre Hospitalier Intercommunal André Grégoire
Brief Summary

Dialysis patients have reduced walking capacity and an important risk of high blood pressure. These complications are associated with a decline in quality of life and increased mortality. The hypothesis of the study is to show that physical activity during the dialysis session in dialyzed patients has a benefit on quality of life, as well as on muscle, cardiovascular and dialysis parameters.

Detailed Description

Dialysis patients have reduced aerobic capacity, walking ability, and an increased risk of hypertension. These complications are associated with a decline in quality of life and increased mortality.

Since asthenia is too intense after the dialysis session, patients are encouraged to perform physical activity during dialysis sessions. Some studies have shown that physical activity during dialysis can have benefits on quality of life and improve muscle parameters, but without this being clinically significant. Other studies show no benefit. The objective of the study is to explore the benefits of physical activity on quality of life, muscle parameters, and biological and dialysis parameters in a cohort of compliant hemodialysis patients.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Adults aged 18 and over, undergoing chronic hemodialysis at CHI André Grégoire for more than 3 months.
  • Consent to participate in physical activity during dialysis sessions.
  • Written informed consent.
  • Affiliation with a social security system
Exclusion Criteria
  • Lower limb amputation without a prosthesis.
  • Non-healed foot wounds.
  • Hemoglobin < 8 g/dl.
  • Patient refusal to participate.
  • Severe respiratory (oxygen dependence) or cardiac disease (NYHA class 3 or 4, LVEF < 30%).
  • Advanced dementia or psychiatric illness impeding cooperation, or refusal to consent.
  • Non-French speaking patients unable to understand the study.
  • Patients under guardianship.
  • Advanced osteoarthritis, recent hip or knee prosthesis (< 3 months).
  • Hypotension (BP < 90/40 mmHg) or hypertension (BP > 180/110 mmHg).
  • Fever (temperature >= 38°C).
  • Hypoglycemia (fingerstick glucose < 0.8 g/l) in diabetic patients.
  • Dyspnea or desaturation in ambient air < 95%.
  • COVID-19 symptoms within the last 21 days, positive PCR test, unable to pedal.
  • Chest pain or unstable angina.
  • Muscle or joint contraindications to the pedal exerciser as assessed by a physiotherapist

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Single group. This group will practice physical activity during dialysis sessions.physical activityExercise using the LEMCO Hospital Bed Pedal Exerciser during dialysis.
Primary Outcome Measures
NameTimeMethod
Change in the quality of life of patients17 weeks

Score of the Short Form-36 (SF36) questionnaire. The SF36 score varies from 0 to 100. A low score reflects a perception of poor health, loss of function, and presence of pain.

A high score reflects a perception of good health, an absence of functional deficit and pain.

Secondary Outcome Measures
NameTimeMethod
Change in blood pressure17 weeks

Measurement of systolic and diastolic blood pressure

Change in heart rate17 weeks

measurement of pulse

Change in muscle parameters17 weeks

Score of the Medical research council scale (MRC)

Change in nutritional parameters17 weeks

Measurement of body mass index (BMI)

Change in glycemic control17 weeks

Levels of prealbumin

Change in dialysis parameters (KT/V= clearance time/volume)17 weeks

measurement of clearance time/volume (KT/V)

Change in inflammatory parameters17 weeks

measurement of CRP

Change in lipid profile17 weeks

Measurement of total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides

Trial Locations

Locations (1)

CHI Andre Gergoire

🇫🇷

Montreuil, France

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