Kidney Failure, ChronicNCT01273753
Effects of Intradialytic Exercise as Assessed by Bioimpedance Analysis and Blood Volume Monitoring
A study testing Intradialytic exercise in people with Kidney Failure, Chronic, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of exercise during dialysis using objective measures of fluid status determination, specifically bioimpedance analysis (BIA) and blood volume monitoring (BVM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Intradialytic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18yrs and older
- End-stage renal disease on thrice weekly maintenance hemodialysis for at least 3 months
- Stable dry weight for the preceding month
- Stable dialysis prescription for the preceding month
- Average interdialytic weight gain at least 1kg but less than 4% of total body weight.
Who cannot join
- Patients receiving dialysis for acute renal failure
- Hospitalization >1 day in the preceding month
- Inability to complete exercise regimen or medical contraindication to exercise regimen
- Patients in whom a dry weight is yet to be established
- History of non-compliance with dialysis therapy (defined as > 3 missed treatments in a month)
- Inability to remain in horizontal position for duration of a dialysis session.
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- Amputation of a limb other than fingers or toes.
- Pace maker, defibrillator, implantable pump, artificial joint, pins, plates or other types of metal objects in the body (other than dental fillings).
- Coronary stents or metal suture material in the heart.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48103
About this study
Official title: Using Bioimpedance Analysis and Blood Volume Monitoring to Assess the Impact of Intradialytic Exercise
The purpose of this study is to examine the impact of exercise during dialysis using objective measures of fluid status determination, specifically bioimpedance analysis (BIA) and blood volume monitoring (BVM). We hypothesize that exercise during dialysis will be associated with more stable blood pressures and that this will be reflected in different output from BIA and BVM monitoring.
Read the detailed description
Achieving dry weight (DW) is essential for the optimal health of dialysis patients. Despite being one of the most basic and important factors in the management of hemodialysis patients, there are many obstacles to achieving DW. One problem underlying optimal fluid status management lies in the clinical assessment used to determine DW. The current standard is clinical judgment which is often reactive (ie. setting a weight below which the patient develops hypotension or cramping) instead of goal directed (ie. trying to achieve defined target measures). Moreover, DW is a dynamic parameter that changes in patients over time, and ongoing assessment remains reactive to changes in clinical status instead of proactively based on monitoring of validated measures. A primary impediment to achieving DW is the relatively short time during dialysis limiting vascular refilling and leading to complications of hypotension and other adverse sequelae of relatively rapid volume removal. The evaluation of interventions aimed at improving symptoms and preventing complications will be scientifically strengthened by objective assessment of the patient's volume. Fortunately two objective clinically validated tools to assess volume status have emerged: bioimpedance (BIA) which allows assessment of the patient's hydration status and blood volume monitoring (BVM) which allows direct measure of the rate of vascular refilling during dialysis. These will be essential in understanding the impact of therapeutic interventions directed at improving achievement of DW.
The next important consideration is selecting an intervention that shows promise in assisting patients in achieving DW. While many interventions deserve careful analysis we select exercise because of the additional cardiovascular benefits of exercise, and it fits into our outpatient program as part of achieving our overall outpatient wellness objectives. To this end we propose the following specific aim:
Specific Aim: Systematically evaluate the effects of exercise on hemodynamic stability and achievement of dry weight by testing the following hypotheses.
Hypothesis 1: Exercise bike riding during dialysis improves vascular refilling as determined by BVM.
Hypothesis 2: Exercise bike riding during dialysis improves (leads to a reduction in) tissue hydration status as determined by BIA.
Hypothesis 3: Improved intra-dialytic blood pressure stability is directly related to improved vascular refilling as assessed by BVM, which is in turn related to improved (reduced) tissue hydration as assessed by BIA.
Hypothesis 4: Intravascular refilling (assessed by BVM) is directly related to reduction in tissue hydration (assess by BIA).
- Conditions
- Kidney Failure, Chronic
- Being tested
- Intradialytic exercise
- Keywords
- End-stage renal disease, Hemodialysis, Bioimpedance analysis, Blood volume monitoring
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic exerciseOther
Patients will exercise using a stationary foot pedal cycle for 20 minutes at the beginning of hemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | After baseline measurements, all subjects will undergo a phase involving intradialytic exercise. Subjects will serve as their own controls. Receives: Other: Intradialytic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bioimpedance analysis trend during dialysis
The investigators will assess the impact of intradialytic exercise on body composition and fluid removal by comparing BIA measurements and trends between dialysis treatments. The baseline measurement will occur during standard usual dialysis, while the 4 week meaurement will occur during dialysis with exercise.
Measured: Baseline (no exercise) and 4 weeks (with exercise)
Secondary outcomes (1)
Blood volume monitoring
Blood volume monitoring will be done during dialysis to assess the impact of exercise on the slope of blood volume changes.
Measured: Baseline (no exercise) and 4 weeks (with exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Research Institute
- Responsible party
- Principal investigator, Michael Heung, University of Michigan
- Investigators
- Michael Heung, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273753
- Sponsor's protocol ID
- Heung-BIA1
- Status last verified
- Dec 2014
- First submitted
- 6 Jan 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Bioimpedance Analysis and Blood Volume Monitoring to Assess the Impact of Intradialytic Exercise
- ClinicalTrials.gov ID
- NCT01273753
- Acronym / sponsor ID
- Heung-BIA1
- Conditions
- Kidney Failure, Chronic
- Keywords
- End-stage renal disease, Hemodialysis, Bioimpedance analysis, Blood volume monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Renal Research Institute
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jan 2011 (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 examine the impact of exercise during dialysis using objective measures of fluid status determination, specifically bioimpedance analysis (BIA) and blood volume monitoring (BVM). We hypothesize that exercise during dialysis will be associated with more stable blood pressures and that this will be reflected in different output from BIA and BVM monitoring.
Detailed description
Achieving dry weight (DW) is essential for the optimal health of dialysis patients. Despite being one of the most basic and important factors in the management of hemodialysis patients, there are many obstacles to achieving DW. One problem underlying optimal fluid status management lies in the clinical assessment used to determine DW. The current standard is clinical judgment which is often reactive (ie. setting a weight below which the patient develops hypotension or cramping) instead of goal directed (ie. trying to achieve defined target measures). Moreover, DW is a dynamic parameter that changes in patients over time, and ongoing assessment remains reactive to changes in clinical status instead of proactively based on monitoring of validated measures. A primary impediment to achieving DW is the relatively short time during dialysis limiting vascular refilling and leading to complications of hypotension and other adverse sequelae of relatively rapid volume removal. The evaluation of interventions aimed at improving symptoms and preventing complications will be scientifically strengthened by objective assessment of the patient's volume. Fortunately two objective clinically validated tools to assess volume status have emerged: bioimpedance (BIA) which allows assessment of the patient's hydration status and blood volume monitoring (BVM) which allows direct measure of the rate of vascular refilling during dialysis. These will be essential in understanding the impact of therapeutic interventions directed at improving achievement of DW.
The next important consideration is selecting an intervention that shows promise in assisting patients in achieving DW. While many interventions deserve careful analysis we select exercise because of the additional cardiovascular benefits of exercise, and it fits into our outpatient program as part of achieving our overall outpatient wellness objectives. To this end we propose the following specific aim:
Specific Aim: Systematically evaluate the effects of exercise on hemodynamic stability and achievement of dry weight by testing the following hypotheses.
Hypothesis 1: Exercise bike riding during dialysis improves vascular refilling as determined by BVM.
Hypothesis 2: Exercise bike riding during dialysis improves (leads to a reduction in) tissue hydration status as determined by BIA.
Hypothesis 3: Improved intra-dialytic blood pressure stability is directly related to improved vascular refilling as assessed by BVM, which is in turn related to improved (reduced) tissue hydration as assessed by BIA.
Hypothesis 4: Intravascular refilling (assessed by BVM) is directly related to reduction in tissue hydration (assess by BIA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Other: Intradialytic exerciseAfter baseline measurements, all subjects will undergo a phase involving intradialytic exercise. Subjects will serve as their own controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18yrs and older
- End-stage renal disease on thrice weekly maintenance hemodialysis for at least 3 months
- Stable dry weight for the preceding month
- Stable dialysis prescription for the preceding month
- Average interdialytic weight gain at least 1kg but less than 4% of total body weight.
Key exclusion criteria (9 listed)
- Patients receiving dialysis for acute renal failure
- Hospitalization >1 day in the preceding month
- Inability to complete exercise regimen or medical contraindication to exercise regimen
- Patients in whom a dry weight is yet to be established
- History of non-compliance with dialysis therapy (defined as > 3 missed treatments in a month)
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 |
|---|---|---|
| Intradialytic exercisePatients will exercise using a stationary foot pedal cycle for 20 minutes at the beginning of hemodialysis. | Other | Exercise |
Primary outcome
Change in bioimpedance analysis trend during dialysis
Time frame: Baseline (no exercise) and 4 weeks (with exercise)
The investigators will assess the impact of intradialytic exercise on body composition and fluid removal by comparing BIA measurements and trends between dialysis treatments. The baseline measurement will occur during standard usual dialysis, while the 4 week meaurement will occur during dialysis with exercise.
1 secondary outcome
Blood volume monitoring
Time frame: Baseline (no exercise) and 4 weeks (with exercise)
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 2 Dec 2014.
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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.
Michael Heung, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic exercise in people with Kidney Failure, Chronic, run by University of Michigan at 1 site in United States.
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 5 inclusion and 9 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 2 Dec 2014. 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 United States. 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?
Change in bioimpedance analysis trend during dialysis (time frame: Baseline (no exercise) and 4 weeks (with exercise)). 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 2 Dec 2014.