Clinical trial NCT01866891: Effects of Physical Activity on the Microcirculation in Hemodialysis Patients
Official title: Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Patients
Keywords: hemodialysis
microcirculation
physical perdialytic activity
cycling
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Increase of cutaneous lower extremity perfusion.
timeFrame: TcPO2 will be performed at the inclusion and just after the end of the three month study period
Secondary outcomes:
measure: Vascular assessment : Doppler and Index of systolic blood pressure
timeFrame: At the inclusion and after the end of the three month study period
measure: Related quality of life
timeFrame: at the inclusion and after the end of the three month study period
measure: Appetite (score)
timeFrame: at the inclusion and after the end of the three month study period
measure: Daily activity (Seven days pedometers)
timeFrame: at the inclusion and after the end of the three month study period
measure: Protein intake (n-PCR)
timeFrame: at the inclusion and after the end of the three month study period
measure: nutritional biological status (creatinin, albumin and transthyretin protein level)
timeFrame: at the inclusion and after the end of the three month study period
measure: strength (handgrip test)
timeFrame: at the inclusion and after the end of the three month study period
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
References: