Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?

January 13, 2012 updated by: Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg

Does Moderate Physical Activity in Chronic Hemodialysis Patients Reduce Inflammation Via Inhibition of Proinflammatory Monocyte Activity?

The purpose of this study is to observe a potential benefit of moderate physical activity by using bed mounted cycles during hemodialysis treatment sessions on inflammatory markers in the blood of patients with end-stage renal disease (ESRD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of inflammation (e.g., serum CRP values) and accumulation of proinflammatory monocyte populations in the circulation. The level of inflammation is highly predictive for cardiovascular disease and mortality. Physical activity has been shown to improve dialysis efficacy by improving the elimination of retention solutes. In healthy individuals, sports activity influences inflammatory immune parameters. The study will observe the influence of moderate physical activity (using a bed mounted cycle for 30min during dialysis thrice weekly) on circulating monocyte subpopulations and inflammatory proteins over a 9 month period in 16 chronic hemodialysis patients.

Study Type

Observational

Enrollment (Actual)

16

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

  • Germany
    • Sachsen-Anhalt
      • Halle(Saale), Sachsen-Anhalt, Germany, D06120
        • Department of Internal Medicine II

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

End-stage renal disease patients on chronic hemodialysis therapy

Description

Inclusion Criteria:

  • chronic hemodialysis treatment for at least three months
  • three dialysis sessions per week
  • good general clinical condition
  • stable hemodynamics during the most recent three dialysis sessions

Exclusion Criteria:

  • conditions making the patient unable to use the bed mounted cycle (amputations, joint disease etc)
  • clinically obvious acute infections
  • active malignancy
  • pathologic results of spiroergometry or echocardiography that imply an elevated risk of participation
  • myocardial infarction within the last 12 weeks
  • uncontrolled arterial hypertension
  • uncontrolled diabetes mellitis with frequent hypoglycemia
  • unability to understand and consent the protocol

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hemodialysis patients
chronic hemodialysis patients with elevated inflammation markers
Behavioral: moderate physical activity
bed mounted cycles for physical activity for 30 min during each hemodialysis session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composition of monocyte subpopulations as defined by CD14 and CD16 expression
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum CRP values
Time Frame: 6 months
6 months
Dialysis quality (kt/V, URR)
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

  • Study Director: Matthias Girndt, MD, Martin-Luther-University Halle-Wittenberg, Germany

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

January 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIM2H-2009-01
  • Roux 19/39
  • KfH 2009-0010

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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