End-stage Renal DiseaseNCT00893165
Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?
An observational study of End-stage Renal Disease and Hemodialysis, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-stage Renal Disease, Hemodialysis
- What is being tested?
- moderate physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-stage renal disease patients on chronic hemodialysis therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Moderate Physical Activity in Chronic Hemodialysis Patients Reduce Inflammation Via Inhibition of Proinflammatory Monocyte Activity?
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).
Read the 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
- Being tested
- moderate physical activity
- Keywords
- inflammation, cardiovascular disease
- Medical subject headings
- Kidney Failure, Chronic, Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate physical activityBehavioural
bed mounted cycles for physical activity for 30 min during each hemodialysis session
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis patients | chronic hemodialysis patients with elevated inflammation markers Receives: Behavioral: moderate physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of monocyte subpopulations as defined by CD14 and CD16 expression
Measured: 6 months
Secondary outcomes (2)
Serum CRP values
Measured: 6 months
Dialysis quality (kt/V, URR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Girndt, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Matthias Girndt, MD, Study director, Martin-Luther-University Halle-Wittenberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893165
- Sponsor's protocol ID
- KIM2H-2009-01
- Other IDs
- Roux 19/39, KfH 2009-0010
- Status last verified
- Jan 2012
- First submitted
- 1 May 2009
- Last updated
- 18 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Moderate Physical Activity in Chronic Hemodialysis Patients Reduce Inflammation Via Inhibition of Proinflammatory Monocyte Activity?
- ClinicalTrials.gov ID
- NCT00893165
- Acronym / sponsor ID
- KIM2H-2009-01
- Conditions
- End-stage Renal Disease, Hemodialysis
- Keywords
- inflammation, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemodialysis patients | – | Behavioral: moderate physical activitychronic hemodialysis patients with elevated inflammation markers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients on chronic hemodialysis therapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| moderate physical activitybed mounted cycles for physical activity for 30 min during each hemodialysis session | Behavioural | hemodialysis patients |
Primary outcome
Composition of monocyte subpopulations as defined by CD14 and CD16 expression
Time frame: 6 months
2 secondary outcomes
Serum CRP values
Time frame: 6 months
Dialysis quality (kt/V, URR)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Girndt, MD study director
Martin-Luther-University Halle-Wittenberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease and Hemodialysis, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of monocyte subpopulations as defined by CD14 and CD16 expression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.