Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?

NCT00893165 | Completed

• 3 other identifiers: KIM2H-2009-01Roux 19/39KfH 2009-0010
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

End-stage Renal Disease; Hemodialysis

Keywords

inflammation; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Composition of monocyte subpopulations as defined by CD14 and CD16 expression

  6 months

Secondary Outcomes (2)

• Serum CRP values

  6 months

• Dialysis quality (kt/V, URR)

  6 months

Study Arms (1)

hemodialysis patients

chronic hemodialysis patients with elevated inflammation markers

Behavioral: moderate physical activity

Interventions

moderate physical activity BEHAVIORAL

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

hemodialysis patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End-stage renal disease patients on chronic hemodialysis therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead

Study Sites (1)

Department of Internal Medicine II

Halle, Saxony-Anhalt, D06120, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and DNA samples

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias Girndt, MD

  Martin-Luther-University Halle-Wittenberg, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 5, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

DE (1)