Chronic Renal InsufficiencyPhase 4NCT02050035
Exercise and Vascular Function in Chronic Kidney Disease
A Phase 4 study testing Aerobic Exercise Training in people with Chronic Renal Insufficiency, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise training on blood vessel function in Stages 1-4 Chronic Kidney Disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Insufficiency
- What is being tested?
- Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 31 Jul 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CKD Exercise and CKD Control Arms: Stage 1 - 4 Chronic Kidney Disease (eGFR 15 - 90 ml/min/1.73m2)
- Healthy Control Arm: eGFR > 90 ml/min/1.73m2)
Who cannot join
- History of cardiovascular disease
- Uncontrolled hypertension
- Lung disease
- Liver disease
- Cancer
- Immunosuppressant or antiretroviral therapy
Show all 10Show fewer
- Current tobacco use
- Pregnancy
- Hormone replacement therapy
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713
About this study
The purpose of this study is to investigate the effects of 12 weeks of aerobic exercise training on blood vessel function in Stages 1-4 Chronic Kidney Disease.
Read the detailed description
The endothelium lines the inside of the blood vessels. A healthy endothelial lining acts as a defense mechanism against vascular injury, mediating vascular tone, vascular structure, and blood-vessel wall relations. Endothelial dysfunction marks the occurrence of cardiovascular injuries and is a critical step in the development of cardiovascular disease. Individuals with Chronic Kidney Disease (CKD) have an increased risk of cardiovascular disease and this may be related to poor blood vessel function. Interventions to improve blood vessel function in CKD are needed. Exercise training has been shown to improve blood vessel function in older subjects and those with heart disease but this has not been investigated in CKD. The National Kidney Foundation recommends exercise for dialysis patients to reduce cardiovascular risk however there is very little data regarding the benefits of exercise in earlier stages of CKD. The purpose of this study is to determine the effect of 12 weeks of exercise training on blood vessel function in moderate to severe CKD.
- Conditions
- Chronic Renal Insufficiency
- Being tested
- Aerobic Exercise Training
- Keywords
- Exercise Therapy, Endothelium, vascular, Blood Vessels
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingOther
Supervised outpatient moderate to vigorous aerobic training at 60% - 85% heart rate reserve, carried out for 45 minutes, three times per week over a twelve week period.
| Study group | Role | What they receive |
|---|---|---|
| CKD Aerobic Exercise Training | Experimental | Chronic Kidney Disease participants randomly allocated to the CKD Exercise arm will receive 12 weeks of Aerobic Exercise Training three times per week. Receives: Other: Aerobic Exercise Training |
| CKD Control | No intervention | Chronic Kidney Disease participants allocated to the the CKD Control arm will receive their standard routine care over a 12 week period. |
| Healthy Control | No intervention | Healthy participants will act as comparators, they will undergo baseline testing only and will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Conduit artery endothelial function assessed by brachial artery flow mediated dilation; Microvascular endothelial function assessed by cutaneous vasodilation in response to local heating measured by microdialysis and laser Doppler flowmetry.
Measured: Change from baseline at 12 weeks
Secondary outcomes (12)
Microvascular function
Nitric oxide contribution to cutaneous microvascular vasodilation in response to local heating assessed by microdialysis and laser Doppler flowmetry
Measured: Change from baseline at 12 weeks
Oxidative stress contribution to vascular dysfunction
Oxidative stress contribution to cutaneous vasodilation dysfunction in response to local heating assessed by microdialysis and laser Doppler flowmetry.
Measured: Change from baseline at 12 weeks
Endothelial cell oxidative stress
Endothelial cell nitrotyrosine, NADPH oxidase, MnSOD oxidase content obtained from antecubital vein endothelial cells and assessed by fluorescence microscopy.
Measured: Changes from baseline at 12 weeks
Plasma Oxidized Low Density Lipoprotein
Plasma oxidized low density lipoprotein measured by ELISA
Measured: Change from baseline at 12 weeks
F2-isoprostanes
Urinary F2-isoprostanes measured by ELISA
Measured: Change from baseline at 12 weeks
Pulse Wave Analysis
Central blood pressure and augmentation index assessed by oscillometry and radial tonometry
Measured: Change from baseline at 12 weeks
Arterial Stiffness
Carotid to femoral pulse wave velocity and assessed by tonometry
Measured: Change from baseline at 12 weeks
Ambulatory Blood Pressure
24 hour blood pressure recorded by oscillometric monitors
Measured: Change from baseline at 12 weeks
Peak Aerobic Capacity
Peak oxygen uptake (VO2peak/max) during incremental cycling exercise until exhaustion
Measured: Change from baseline at 12 weeks
Physical Function
Dexterity by the '9-Hole Peg Test'; Endurance by the '2 Minute Walk Endurance Test'; locomotion by the '4 Meter Gait Speed Test'; isometric handgrip strength test by handgrip dynamometry.
Measured: Change from baseline at 12 weeks
Habitual Physical Activity
Daily average energy expenditure, step count and physical activity intensity level by accelerometry.
Measured: Change from baseline at 12 weeks
Knee Extensor Strength
Maximal isometric knee extensor strength
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal InsufficiencyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Edwards, University of Delaware
- Investigators
- David Edwards, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050035
- Sponsor's protocol ID
- KAAP32212114000
- Other IDs
- 1R01HL113514-01A1, 364680-6
- Status last verified
- Aug 2017
- First submitted
- 28 Jan 2014
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirkman DL, Ramick MG, Muth BJ, Stock JM, Townsend RR, Edwards DG. A randomized trial of aerobic exercise in chronic kidney disease: Evidence for blunted cardiopulmonary adaptations. Ann Phys Rehabil Med. 2021 Nov;64(6):101469. doi: 10.1016/j.rehab.2020.101469. Epub 2021 Oct 26.
PubMed 33316435
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Vascular Function in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02050035
- Acronym / sponsor ID
- KAAP32212114000
- Conditions
- Chronic Renal Insufficiency
- Keywords
- Exercise Therapy, Endothelium, vascular, Blood Vessels
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 30 Jan 2014 (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 investigate the effects of 12 weeks of aerobic exercise training on blood vessel function in Stages 1-4 Chronic Kidney Disease.
Detailed description
The endothelium lines the inside of the blood vessels. A healthy endothelial lining acts as a defense mechanism against vascular injury, mediating vascular tone, vascular structure, and blood-vessel wall relations. Endothelial dysfunction marks the occurrence of cardiovascular injuries and is a critical step in the development of cardiovascular disease. Individuals with Chronic Kidney Disease (CKD) have an increased risk of cardiovascular disease and this may be related to poor blood vessel function. Interventions to improve blood vessel function in CKD are needed. Exercise training has been shown to improve blood vessel function in older subjects and those with heart disease but this has not been investigated in CKD. The National Kidney Foundation recommends exercise for dialysis patients to reduce cardiovascular risk however there is very little data regarding the benefits of exercise in earlier stages of CKD. The purpose of this study is to determine the effect of 12 weeks of exercise training on blood vessel function in moderate to severe CKD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD Aerobic Exercise Training | Experimental | Other: Aerobic Exercise TrainingChronic Kidney Disease participants randomly allocated to the CKD Exercise arm will receive 12 weeks of Aerobic Exercise Training three times per week. |
| CKD Control | No intervention | –Chronic Kidney Disease participants allocated to the the CKD Control arm will receive their standard routine care over a 12 week period. |
| Healthy Control | No intervention | –Healthy participants will act as comparators, they will undergo baseline testing only and will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD Exercise and CKD Control Arms: Stage 1 - 4 Chronic Kidney Disease (eGFR 15 - 90 ml/min/1.73m2)
- Healthy Control Arm: eGFR > 90 ml/min/1.73m2)
Key exclusion criteria (10 listed)
- History of cardiovascular disease
- Uncontrolled hypertension
- Lung disease
- Liver disease
- Cancer
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 |
|---|---|---|
| Aerobic Exercise TrainingSupervised outpatient moderate to vigorous aerobic training at 60% - 85% heart rate reserve, carried out for 45 minutes, three times per week over a twelve week period. | Other | CKD Aerobic Exercise Training |
Primary outcome
Endothelial Function
Time frame: Change from baseline at 12 weeks
Conduit artery endothelial function assessed by brachial artery flow mediated dilation; Microvascular endothelial function assessed by cutaneous vasodilation in response to local heating measured by microdialysis and laser Doppler flowmetry.
12 secondary outcomes
Microvascular function
Time frame: Change from baseline at 12 weeks
Oxidative stress contribution to vascular dysfunction
Time frame: Change from baseline at 12 weeks
Endothelial cell oxidative stress
Time frame: Changes from baseline at 12 weeks
Plasma Oxidized Low Density Lipoprotein
Time frame: Change from baseline at 12 weeks
F2-isoprostanes
Time frame: Change from baseline at 12 weeks
Pulse Wave Analysis
Time frame: Change from baseline at 12 weeks
Arterial Stiffness
Time frame: Change from baseline at 12 weeks
Ambulatory Blood Pressure
Time frame: Change from baseline at 12 weeks
Peak Aerobic Capacity
Time frame: Change from baseline at 12 weeks
Physical Function
Time frame: Change from baseline at 12 weeks
Habitual Physical Activity
Time frame: Change from baseline at 12 weeks
Knee Extensor Strength
Time frame: Change from baseline at 12 weeks
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 31 Aug 2017.
- Derived from this study: PubMed 33316435Kirkman DL, Ramick MG, Muth BJ, Stock JM, Townsend RR, Edwards DG. A randomized trial of aerobic exercise in chronic kidney disease: Evidence for blunted cardiopulmonary adaptations. Ann Phys Rehabil Med. 2021 Nov;64(6):101469. doi: 10.1016/j.rehab.2020.101469. Epub 2021 Oct 26.
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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.
David Edwards, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aerobic Exercise Training in people with Chronic Renal Insufficiency, run by University of Delaware 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 2 inclusion and 10 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 31 Aug 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Endothelial Function (time frame: Change from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02050035, which also lists 1 linked publication.
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 31 Aug 2017.