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Completed

NCT Number: NCT01866891

Effects of Physical Activity on the Microcirculation in 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.

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Key information

Conditions

Hemodialysis Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three months of regular perdialytic physical activity (cycling)

Other

Cycling, in lying position, at a rate of thirty minutes per dialysis session (three a week), regardless of performance

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ACTIVDIAL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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