Focus Chronic Kidney Disease With HypertensionPACENCT02112825
Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
A study testing Exercise in people with Focus Chronic Kidney Disease With Hypertension, run by University of Minnesota at 1 site in United States.
Trial summary
The general objective of the study is to investigate the effect of regular aerobic exercise on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Focus Chronic Kidney Disease With Hypertension
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Non-diabetic and >18 years of age
- Diagnosed kidney disease with associated hypertension:
- Non-nephrotic range proteinuria at diagnosis
- No active glomerular disease or concomitant systemic inflammatory disease (e.g. lupus)
- Systolic blood pressure >130 and/or diastolic blood pressure >80 mm Hg (on medication)
- An estimated glomerular filtration rate of between 60 ml/min and 15 ml/min.
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- Individuals must be able to provide informed consent
- Perform walking exercise training on a treadmill
- Be able to participate in a 12-week supervised exercise program.
Who cannot join
- Currently participating in a formal exercise program
- Diabetes, active glomerular disease, or systemic inflammatory disease
- Requiring dialysis
- Have an Hematocrit <27%
- Uncontrolled hypertension (>200/110mmHg)
- Peripheral vascular disease.
- An inability to understand English or give consent. Other exclusion criteria are: any contraindications to exercise testing or training as indicated by the American College of Sports Medicine guidelines such as: Unstable coronary heart disease and symptomatic heart failure, exercise capacity limited by health problems such as angina, severe arthritis, or extreme dyspnea on exertion, progressive neuromuscular disease, pulmonary disease, or having undergone a coronary revascularization within the past 6 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The general objective of the study is to investigate the effect of regular aerobic exercise on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and hypertension.
- Being tested
- Exercise
- Keywords
- Exercise, blood pressure, chronic kidney disease
- Medical subject headings
- Motor Activity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Blended supervised-home based walking exercise 3-4 times per week for 30-45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 12 weeks of blended supervised-home based exercise 3-4 times per week for 30-45 minutes Receives: Behavioral: Exercise |
| control | No intervention | Control group asked to continue usual activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
resting and 24-hour ambulatory blood pressure
Measured: at week 0 and at week 12
Secondary outcomes (3)
effective vascular compliance
Pulse wave velocity estimated systemic vascular resistance
Measured: at week 0 and at week 12
endothelial function
measured by brachial artery flow mediated vasodilation
Measured: at week 0 and at week 12
biomarkers associated with blood pressure
Circulating levels of angiotensin 2 Circulating levels of endothelin 1 asymmetric dimethylarginine
Measured: at week 0 and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus Chronic Kidney Disease With HypertensionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf G Bronas, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112825
- Sponsor's protocol ID
- 1207M17821
- Other IDs
- R03DK097318
- Acronym
- PACE
- Status last verified
- Mar 2017
- First submitted
- 10 Apr 2014
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02112825
- Acronym / sponsor ID
- PACE / 1207M17821
- Keywords
- Exercise, blood pressure, chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Apr 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 general objective of the study is to investigate the effect of regular aerobic exercise on resting and 24-hr blood pressure levels in men and women with stage 3-4 kidney disease and hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise12 weeks of blended supervised-home based exercise 3-4 times per week for 30-45 minutes |
| control | No intervention | –Control group asked to continue usual activities |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Non-diabetic and >18 years of age
Key exclusion criteria (7 listed)
- Currently participating in a formal exercise program
- Diabetes, active glomerular disease, or systemic inflammatory disease
- Requiring dialysis
- Have an Hematocrit <27%
- Uncontrolled hypertension (>200/110mmHg)
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 |
|---|---|---|
| ExerciseBlended supervised-home based walking exercise 3-4 times per week for 30-45 minutes | Behavioural | Exercise |
Primary outcome
blood pressure
Time frame: at week 0 and at week 12
resting and 24-hour ambulatory blood pressure
3 secondary outcomes
effective vascular compliance
Time frame: at week 0 and at week 12
endothelial function
Time frame: at week 0 and at week 12
biomarkers associated with blood pressure
Time frame: at week 0 and at week 12
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 6 Mar 2017.
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.
Ulf G Bronas, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Focus Chronic Kidney Disease With Hypertension, run by University of Minnesota 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 9 inclusion and 7 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 6 Mar 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.
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?
blood pressure (time frame: at week 0 and at week 12). 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 6 Mar 2017.