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Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00893165
First received: May 1, 2009
Last updated: January 13, 2012
Last verified: January 2012
History of Changes

May 1, 2009
January 13, 2012
January 2010
October 2011   (final data collection date for primary outcome measure)
Composition of monocyte subpopulations as defined by CD14 and CD16 expression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00893165 on ClinicalTrials.gov Archive Site
  • Serum CRP values [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Dialysis quality (kt/V, URR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?
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).

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.
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum and DNA samples
Non-Probability Sample

End-stage renal disease patients on chronic hemodialysis therapy
  • End-stage Renal Disease
  • Hemodialysis
Behavioral: moderate physical activity
bed mounted cycles for physical activity for 30 min during each hemodialysis session
hemodialysis patients
chronic hemodialysis patients with elevated inflammation markers
Intervention: Behavioral: moderate physical activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00893165
KIM2H-2009-01, Roux 19/39, KfH 2009-0010
Not Provided
Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
Martin-Luther-Universität Halle-Wittenberg
Not Provided
Study Director: Matthias Girndt, MD Martin-Luther-University Halle-Wittenberg, Germany
Martin-Luther-Universität Halle-Wittenberg
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP