Clinical trial NCT06471283: Contribution of Per Dialytic Physical Activity in Chronic Dialysis Patients
Official title: Contribution of Physical Activity Per Dialytic in Chronic Dialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dialysis
Keywords: dialysis patients
physical activity
Lead sponsor: Centre Hospitalier Intercommunal André Grégoire
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the quality of life of patients
timeFrame: 17 weeks
Secondary outcomes:
measure: Change in dialysis parameters (KT/V= clearance time/volume)
timeFrame: 17 weeks
measure: Change in muscle parameters
timeFrame: 17 weeks
measure: Change in nutritional parameters
timeFrame: 17 weeks
measure: Change in inflammatory parameters
timeFrame: 17 weeks
measure: Change in lipid profile
timeFrame: 17 weeks
measure: Change in blood pressure
timeFrame: 17 weeks
measure: Change in heart rate
timeFrame: 17 weeks
measure: Change in glycemic control
timeFrame: 17 weeks
measure: Change in glycemic control
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Montreuil
country: France
facility: CHI Andre Gergoire
Study officials:
affiliation: Centre Hospitalier Intercommunal André Grégoire
name: Marion GAUTHIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho JH, Lee JY, Lee S, Park H, Choi SW, Kim JC. Effect of intradialytic exercise on daily physical activity and sleep quality in maintenance hemodialysis patients. Int Urol Nephrol. 2018 Apr;50(4):745-754. doi: 10.1007/s11255-018-1796-y. Epub 2018 Jan 23.
citation: Assimon MM, Wang L, Flythe JE. Intradialytic Hypertension Frequency and Short-Term Clinical Outcomes Among Individuals Receiving Maintenance Hemodialysis. Am J Hypertens. 2018 Feb 9;31(3):329-339. doi: 10.1093/ajh/hpx186.