Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?

NCT ID: NCT00893165

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

End-stage Renal Disease; Hemodialysis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

hemodialysis patients

chronic hemodialysis patients with elevated inflammation markers

moderate physical activity

Intervention Type: BEHAVIORAL

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

Interventions

moderate physical activity

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: lead

Responsible Party

Matthias Girndt

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Girndt, MD

Role: STUDY_DIRECTOR

Martin-Luther-University Halle-Wittenberg, Germany

Locations

Department of Internal Medicine II

Halle, Saxony-Anhalt, Germany

Countries

Germany

Other Identifiers

Roux 19/39

Identifier Type: -

Identifier Source: secondary_id

KfH 2009-0010

Identifier Type: -

Identifier Source: secondary_id

KIM2H-2009-01

Identifier Type: -

Identifier Source: org_study_id