Back to resultsExercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease (PACE)
Primary Purpose
Focus Chronic Kidney Disease With Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Focus Chronic Kidney Disease With Hypertension focused on measuring Exercise, blood pressure, chronic kidney disease
Eligibility Criteria
Inclusion Criteria:
• 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.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
control
Arm Description
12 weeks of blended supervised-home based exercise 3-4 times per week for 30-45 minutes
Control group asked to continue usual activities
Outcomes
Primary Outcome Measures
blood pressure
resting and 24-hour ambulatory blood pressure
Secondary Outcome Measures
effective vascular compliance
Pulse wave velocity estimated systemic vascular resistance
endothelial function
measured by brachial artery flow mediated vasodilation
biomarkers associated with blood pressure
Circulating levels of angiotensin 2 Circulating levels of endothelin 1 asymmetric dimethylarginine
Full Information
NCT ID
NCT02112825
First Posted
April 10, 2014
Last Updated
March 3, 2017
Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02112825
Brief Title
Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
Acronym
PACE
Official Title
Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus Chronic Kidney Disease With Hypertension
Keywords
Exercise, blood pressure, chronic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
12 weeks of blended supervised-home based exercise 3-4 times per week for 30-45 minutes
Arm Title
control
Arm Type
No Intervention
Arm Description
Control group asked to continue usual activities
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Blended supervised-home based walking exercise 3-4 times per week for 30-45 minutes
Primary Outcome Measure Information:
Title
blood pressure
Description
resting and 24-hour ambulatory blood pressure
Time Frame
at week 0 and at week 12
Secondary Outcome Measure Information:
Title
effective vascular compliance
Description
Pulse wave velocity estimated systemic vascular resistance
Time Frame
at week 0 and at week 12
Title
endothelial function
Description
measured by brachial artery flow mediated vasodilation
Time Frame
at week 0 and at week 12
Title
biomarkers associated with blood pressure
Description
Circulating levels of angiotensin 2 Circulating levels of endothelin 1 asymmetric dimethylarginine
Time Frame
at week 0 and at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• 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.
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf G Bronas, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
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