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

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ClinicalTrials.gov Identifier: NCT01866891
Recruitment Status : Completed
First Posted : June 3, 2013
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hemodialysis Patients Other: Three months of regular perdialytic physical activity (cycling) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients
Study Start Date : April 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866891


Locations
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France
Hôpital Edouard Herriot
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01866891    
Other Study ID Numbers: 2012.744
First Posted: June 3, 2013    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Keywords provided by Hospices Civils de Lyon:
hemodialysis
microcirculation
physical perdialytic activity
cycling