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Completed

NCT Number: NCT00893165

Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?

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).

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Key information

Conditions

End-stage Renal Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine II

Halle, Saxony-Anhalt, D06120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate Physical Activity

Behavioral

bed mounted cycles for physical activity for 30 min during each hemodialysis session

Primary outcomes

  1. Composition of monocyte subpopulations as defined by CD14 and CD16 expression

    Time frame: 6 months

Secondary outcomes

  1. Serum CRP values

    Time frame: 6 months

  2. Dialysis quality (kt/V, URR)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 5, 2009
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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