Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease (PACE)

March 3, 2017 updated by: University of Minnesota
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
12 weeks of blended supervised-home based exercise 3-4 times per week for 30-45 minutes
Behavioral: Exercise
Blended supervised-home based walking exercise 3-4 times per week for 30-45 minutes
No Intervention: control
Control group asked to continue usual activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: at week 0 and at week 12
resting and 24-hour ambulatory blood pressure
at week 0 and at week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effective vascular compliance
Time Frame: at week 0 and at week 12
Pulse wave velocity estimated systemic vascular resistance
at week 0 and at week 12
endothelial function
Time Frame: at week 0 and at week 12
measured by brachial artery flow mediated vasodilation
at week 0 and at week 12
biomarkers associated with blood pressure
Time Frame: at week 0 and at week 12
Circulating levels of angiotensin 2 Circulating levels of endothelin 1 asymmetric dimethylarginine
at week 0 and at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Ulf G Bronas, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1207M17821
  • R03DK097318 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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