Effects of Physical Activity on the Microcirculation in Hemodialysis Patients

Hemodialysis Patients Clinical Trial

— ACTIVDIAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866891
• Other study ID #: 2012.744
• Status: Completed
• Phase: N/A
• First received: May 22, 2013
• Last updated: August 26, 2016
• Start date: April 2012
• Est. completion date: October 2015

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of cutaneous lower extremity perfusion.		TcPO2 will be performed at the inclusion and just after the end of the three month study period	Yes
Secondary	Vascular assessment : Doppler and Index of systolic blood pressure		At the inclusion and after the end of the three month study period	Yes
Secondary	Related quality of life		at the inclusion and after the end of the three month study period	Yes
Secondary	Appetite (score)		at the inclusion and after the end of the three month study period	Yes
Secondary	Daily activity (Seven days pedometers)		at the inclusion and after the end of the three month study period	Yes
Secondary	Protein intake (n-PCR)		at the inclusion and after the end of the three month study period	Yes
Secondary	nutritional biological status (creatinin, albumin and transthyretin protein level)		at the inclusion and after the end of the three month study period	Yes
Secondary	strength (handgrip test)		at the inclusion and after the end of the three month study period	Yes