Effects of Physical Activity on the Microcirculation in Hemodialysis Patients (ACTIVDIAL)

August 26, 2016 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hôpital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 27, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012.744

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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