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Clinical Trials/NCT01866891
NCT01866891
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country27 target enrollmentApril 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemodialysis Patients
Sponsor
Hospices Civils de Lyon
Enrollment
27
Locations
1
Primary Endpoint
Increase of cutaneous lower extremity perfusion.
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2012
End Date
October 1, 2015
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Increase of cutaneous lower extremity perfusion.

Time Frame: TcPO2 will be performed at the inclusion and just after the end of the three month study period

Secondary Outcomes

  • 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)

Study Sites (1)

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