Effects of Physical Activity on the Microcirculation in Hemodialysis Patients

NCT01866891 | Completed DMC

• 1 other identifier: 2012.744
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Patients

Keywords

hemodialysis; microcirculation; physical perdialytic activity; cycling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

single arm

EXPERIMENTAL

Other: Three months of regular perdialytic physical activity (cycling)

Interventions

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

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Subjects protected by the law
• Physical impossibility to achieve exercise
• Medical contraindication to perform physical exercise

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Related Publications (2)

• Pelletier C., Jolivot A., Kalbacher E., Long A., Juillard L. Impact de la pratique d'une activité physique régulière perdialytique sur la microcirculation des membres inférieurs chez les patients hémodialysés chroniques : résultats de l'étude Activdial. Néphrologie & Thérapeutique. 2015;11(5):263. doi:10.1016/j.nephro.2015.07.015.

  RESULT

• Panaye, M., Jolivot, A., Lemoine, S., Villar, E., Fouque, D., & Laville, M. (2014). Outcome and prognosis factors of pregnancies in hemodialysis patients. Nephrology Dialysis Transplantation, 29(Suppl 3), iii520. Poster presented at the 51st ERA-EDTA Congress, Amsterdam, Netherlands.

  RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: June 3, 2013
• Study Start: April 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)