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Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893165
First Posted: May 5, 2009
Last Update Posted: January 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
  Purpose
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).

Condition Intervention
End-stage Renal Disease Hemodialysis Behavioral: moderate physical activity

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Does Moderate Physical Activity in Chronic Hemodialysis Patients Reduce Inflammation Via Inhibition of Proinflammatory Monocyte Activity?

Resource links provided by NLM:


Further study details as provided by Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Composition of monocyte subpopulations as defined by CD14 and CD16 expression [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Serum CRP values [ Time Frame: 6 months ]
  • Dialysis quality (kt/V, URR) [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Serum and DNA samples

Enrollment: 16
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
End-stage renal disease patients on chronic hemodialysis therapy
Criteria

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
  Contacts and Locations
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): NCT00893165


Locations
Germany
Department of Internal Medicine II
Halle(Saale), Sachsen-Anhalt, Germany, D06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Study Director: Matthias Girndt, MD Martin-Luther-University Halle-Wittenberg, Germany
  More Information

Responsible Party: Matthias Girndt, Professor of Internal Medicine, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00893165     History of Changes
Other Study ID Numbers: KIM2H-2009-01
Roux 19/39
KfH 2009-0010
First Submitted: May 1, 2009
First Posted: May 5, 2009
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg:
inflammation
cardiovascular disease

Additional relevant MeSH terms:
Inflammation
Kidney Failure, Chronic
Pathologic Processes
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases