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OpenTrials
Completed

NCT Number: NCT02112825

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Blended supervised-home based walking exercise 3-4 times per week for 30-45 minutes

Primary outcomes

  1. blood pressure

    Time frame: at week 0 and at week 12

    resting and 24-hour ambulatory blood pressure

Secondary outcomes

  1. effective vascular compliance

    Time frame: at week 0 and at week 12

    Pulse wave velocity estimated systemic vascular resistance

  2. endothelial function

    Time frame: at week 0 and at week 12

    measured by brachial artery flow mediated vasodilation

  3. 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

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

Registry information

Acronym: PACE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2014
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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