Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?

Completed

• Conditions: Hemodialysis; End-stage Renal Disease
• Interventions: Behavioral: moderate physical activity

• Registration Number: NCT00893165
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary

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).

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 Timeline

• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Study Start: 2010-01
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hemodialysis patients	moderate physical activity	chronic hemodialysis patients with elevated inflammation markers

Primary Outcome Measures

Name	Time	Method
Composition of monocyte subpopulations as defined by CD14 and CD16 expression	6 months

Secondary Outcome Measures

Name	Time	Method
Serum CRP values	6 months
Dialysis quality (kt/V, URR)	6 months

Trial Locations

Locations (1)

Department of Internal Medicine II; 🇩🇪 Halle(Saale), Sachsen-Anhalt, Germany