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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
  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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Composition of monocyte subpopulations as defined by CD14 and CD16 expression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 1, 2009
Last Updated: January 13, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

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

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

ClinicalTrials.gov processed this record on May 16, 2013