Exercise as an Adjunct Therapy to Reduce Blood Pressure in Chronic Kidney Disease
PACE
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedMarch 6, 2017
March 1, 2017
1.9 years
April 10, 2014
March 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood pressure
resting and 24-hour ambulatory blood pressure
at week 0 and at week 12
Secondary Outcomes (3)
effective vascular compliance
at week 0 and at week 12
endothelial function
at week 0 and at week 12
biomarkers associated with blood pressure
at week 0 and at week 12
Study Arms (2)
Exercise
EXPERIMENTAL12 weeks of blended supervised-home based exercise 3-4 times per week for 30-45 minutes
control
NO INTERVENTIONControl group asked to continue usual activities
Interventions
Blended supervised-home based walking exercise 3-4 times per week for 30-45 minutes
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulf G Bronas, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2014
First Posted
April 14, 2014
Study Start
July 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
March 6, 2017
Record last verified: 2017-03