Effects of Physical Activity on the Microcirculation in Hemodialysis Patients

Study Overview
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Brief Summary
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Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.

Official Title
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Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients

Conditions
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Hemodialysis Patients

Intervention / Treatment
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* Other: Three months of regular perdialytic physical activity (cycling)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients performing chronic hemodialysis for more than 3 months Adult aged > or = 18 years old Information letter delivered to subjects Written free informed consent Clinically stable patients Voluntary patients to perform 30 minutes cycling per dialysis session Social French Security Affiliated subjects Exclusion Criteria: Subjects without inclusion criteria Pregnant women Subjects protected by the law Physical impossibility to achieve exercise Medical contraindication to perform physical exercise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br> | Other: Three months of regular perdialytic physical activity (cycling)<br>* Cycling, in lying position, at a rate of thirty minutes per dialysis session (three a week), regardless of performance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of cutaneous lower extremity perfusion. |  | TcPO2 will be performed at the inclusion and just after the end of the three month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular assessment : Doppler and Index of systolic blood pressure |  | At the inclusion and after the end of the three month study period | 
| Related quality of life |  | at the inclusion and after the end of the three month study period | 
| Appetite (score) |  | at the inclusion and after the end of the three month study period | 
| Daily activity (Seven days pedometers) |  | at the inclusion and after the end of the three month study period | 
| Protein intake (n-PCR) |  | at the inclusion and after the end of the three month study period | 
| nutritional biological status (creatinin, albumin and transthyretin protein level) |  | at the inclusion and after the end of the three month study period | 
| strength (handgrip test) |  | at the inclusion and after the end of the three month study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, microcirculation, physical perdialytic activity, cycling