Effects of Physical Activity on the Microcirculation in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemodialysis Patients
• Interventions: Other: Three months of regular perdialytic physical activity (cycling)

• Registration Number: NCT01866891
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-06-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-26
• Last Update Posted: 2016-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Three months of regular perdialytic physical activity (cycling)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France