- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551119
Physical Activity in Renal Disease (PAIRED): The Effect on Hypertension
Physical Activity in Renal Disease (PAIRED): A Randomized Controlled Trial of the Effect on Hypertension
Background and importance: Hypertension is highly prevalent among Canadians with non-dialysis dependent chronic kidney disease (CKD). It is a modifiable risk factor for both cardiovascular (CV) events and CKD progression. Exercise is an effective strategy for blood pressure (BP) reduction in the general population but in people with CKD, hypertension is mediated by different causes (i.e. vascular stiffness, volume expansion) and it is unclear whether exercise will reduce BP in this population. Consequently, exercise resources are not offered in the routine multidisciplinary care of people with CKD and the prevalence of sedentary behaviour remains double that of the general population. The role of exercise in CKD management is also an important question for patients. From CIHR-supported workshops with patients, the role of lifestyle, such as exercise in CKD was a top research priority.
Research aims: i.To determine the effect of exercise on mean ambulatory systolic blood pressure (SBP) in people with CKD compared to usual care. The investigators hypothesize that exercise training will significantly reduce BP compared to control. ii.To inform the design of a larger, multi-center trial evaluating the effect of exercise on the risk of CKD progression.
Methods: A 160 participant, single center randomized trial of adults from Alberta Kidney Care North CKD clinics, Edmonton, Albert, Canada. Participants with an estimated glomerular filtration rate (eGFR) of 15-44 ml/min per 1.73m2 and SBP >130 mmHg will be randomized, stratified by eGFR (<30 versus ≥ 30) to an exercise intervention or usual care. The main outcome is the difference in 24-hour ambulatory SBP after eight weeks of exercise training between groups. Secondary outcomes include: BPs at eight and 24 weeks, dose of anti-hypertensives, aortic stiffness, CV-risk markers, CV fitness, 7-day accelerometry, quality of life, safety, and in an exploratory analysis, eGFR and proteinuria. The intervention is thrice weekly moderate intensity aerobic exercise supplemented with isometric resistance exercise, targeting 150 minutes per week and delivered over 24-weeks. Phase 1: one supervised weekly sessions and home-based sessions (eight weeks). Phase 2: home-based sessions (16 weeks). To detect a clinically important BP reduction of 5 mmHg between groups requires 128 patients (two sample t-test, alpha 0.05, beta 0.2, common standard deviation of 10 mmHg). Assuming 20% dropout requires 160 patients. For the primary outcome, the investigators will use a mixed linear regression model in which BP is regressed on group, baseline SBP and eGFR, and time point.
Expected outcomes: The findings from this study will address a significant knowledge gap in hypertension management in CKD, inform care-delivery and the design of a larger study on CKD progression. This proposal aligns with priorities for both patients and decision makers: to identify the role of exercise in CKD management and to reshape the delivery of renal care so that it is more consistent with patient values and preferences.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T5H 3V9
- Royal Alexandra Hospital
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Edmonton, Alberta, Canada, T6L5X8
- Grey Nuns Hospital
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Edmonton, Alberta, Canada, T6G 2P4
- University of Alberta Hospital, outpatient dialysis unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Resting SBP >120 mmHg systolic on screening BP clinic measurements (with an electronic sphygmomanometer, mean of three readings after first reading is discarded) and at least one previous SBP measurement above 120 mmHg on a separate occasion within the past six months (home or clinic measurement).
- Stable on blood pressure medications for the past eight weeks
- eGFR 15-44 ml/min per 1.73m2 eGFR between 15-44 ml/min per 1.73m2 within the last three months and one additional value in this rage in the last 12 months.
- Independent ambulation with or without an assistive device for at least three consecutive minutes
- Cognition and English language sufficient enough to understand written information, provide consent, and comply with the testing and interventions
- Approval of the attending nephrologist
- No significant exercise-induced arrhythmia or new ischemia on submaximal incremental exercise testing (final screening step)
Exclusion Criteria:
- Resting SBP >160 mmHg or DBP > 110 mmHg on screening BP clinic measurement (Note: the individual may be re-screened 8 weeks after medication adjustment)
- Arm circumference greater than 54 centimeters (size limit of large ABPM cuff)
- Recent (<6 weeks) or planned (<6 months) major cardiovascular events or procedures
- Any known contraindication to exercise (American College of Sports Medicine Guidelines)
Acute myocardial infarction (3-5 days) or unstable angina; Uncontrolled symptomatic arrhythmias; Active endocarditis; Acute myocarditis or pericarditis; Symptomatic severe aortic stenosis; Acute pulmonary embolism or deep vein thrombosis; Suspected dissecting aneurysm; Uncontrolled asthma; Uncontrolled pulmonary edema; Room air desaturation to <85%; Acute non-cardiopulmonary disorder that may affect exercise performance (infection, orthopedic problem); Mental impairment leading to inability to cooperate; Uncontrolled hypertension (as above)
- Pregnant or planning to become pregnant
- Transplant
- Life expectancy or predicted time to renal replacement therapy <9 months (attending physician judgment)
- Planned move or hospital admission within the next 9 months
- Currently enrolled in an interventional clinical trial; currently enrolled in a structured exercise program or performing regular exercise training > 2 day/week in the last 3 months
- Taking other medications known to affect blood pressure (prednisone cyclosporine) and expected adjustment in the next 9 months
- Significant barrier to participation in a home exercise program or an insurmountable barrier to attend in-center training sessions.
Study Plan
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
Personnel experienced in training people with chronic conditions (exercise specialist) will supervise the exercise training. At each in-center session in phase 1, the patient's exercise will be monitored to assess whether they are achieving target levels. Training intensities will be prescribed based on the most recent exercise test. Phase 1: an eight-week program of once weekly-supervised facility-based exercise sessions and twice weekly home-based sessions. Phase 2: a 16-week home-based exercise program overseen by an exercise specialist. During this phase, participants will be progressed through their home-based exercise program from Phase 1 on an individual basis. i. Frequency. A minimum of three exercise sessions per week. ii. Intensity. A moderate intensity (40-60% heart rate reserve) based on exercise testing. iii. Time. 150 minutes of exercise per week. iv. Type. We will prescribe aerobic exercise supplemented with isometric resistance exercises. |
See previous description
|
Other: Enhanced usual care
Participants in the control group will perform accelerometry.
This is enhanced usual care because physical activity measurement is not routinely performed in CKD clinics.
Control arm participants will only receive their accelerometry data after they have completed the study.
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See previous description
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-hour ambulatory SBP
Time Frame: 8 weeks
|
mean 24-hour ambulatory systolic blood pressure
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
antihypertensive use
Time Frame: 8 and 24 weeks
|
Using the assigned DDD (WHO) for that drug
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8 and 24 weeks
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KDQOL-36
Time Frame: 8 and 24 weeks
|
Kidney Disease and Quality of Life instrument - this is a short form that includes the SF-12 plus the burden of kidney disease, symptoms/problems of kidney disease, and effects of kidney disease scales from the KDQOL-SF
|
8 and 24 weeks
|
IPAQ-SF
Time Frame: 8 and 24 weeks
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International Physical Activity Questionnaire - Short Form
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8 and 24 weeks
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SEE scale
Time Frame: 8 and 24 weeks
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Self Efficacy for Exercise questionnaire - the total score ranges from 0 to 90.
High scores indicate higher self-efficacy in exercise.
There are 9 questions; responses vary from 0 to 10.
The mean score on each question is 5.5.
|
8 and 24 weeks
|
EQ-5D
Time Frame: 8 and 24 weeks
|
European Quality of Life (EuroQOL) health questionnaire with 5 dimensions
|
8 and 24 weeks
|
pulse wave velocity
Time Frame: 8 and 24 weeks
|
measurement of aortic stiffness (femoral carotid, radial carotid)
|
8 and 24 weeks
|
body mass index
Time Frame: 8 and 24 weeks
|
calculated as weight in kilograms divided by height in meters squared
|
8 and 24 weeks
|
Fat mass
Time Frame: 8 and 24 weeks
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Body composition using bioimpedance spectroscopy
|
8 and 24 weeks
|
clinic blood pressure
Time Frame: 8 and 24 weeks
|
with a oscillometric sphygmomanometer
|
8 and 24 weeks
|
Oxygen uptake (VO2 peak)
Time Frame: 8 and 24 weeks
|
Cardiopulmonary exercise testing
|
8 and 24 weeks
|
estimated glomerular filtration rate
Time Frame: 8 and 24 weeks
|
8 and 24 weeks
|
|
c-reactive protein
Time Frame: 8 and 24 weeks
|
8 and 24 weeks
|
|
total cholesterol
Time Frame: 8 and 24 weeks
|
8 and 24 weeks
|
|
LDL
Time Frame: 8 and 24 weeks
|
8 and 24 weeks
|
|
HDL
Time Frame: 8 and 24 weeks
|
8 and 24 weeks
|
|
triglycerides
Time Frame: 8 and 24 weeks
|
8 and 24 weeks
|
|
HgA1C
Time Frame: 24 weeks
|
glycated hemoglobin
|
24 weeks
|
spot urinary sodium
Time Frame: 8 and 24 weeks
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measured on a non-exercise day
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8 and 24 weeks
|
spot urinary protein
Time Frame: 8 and 24 weeks
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measured on a non-exercise day
|
8 and 24 weeks
|
7-day accelerometry
Time Frame: 8 and 24 weeks
|
number of steps
|
8 and 24 weeks
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7-day accelerometry
Time Frame: 8 and 24 weeks
|
sedentary time
|
8 and 24 weeks
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7-day accelerometry
Time Frame: 8 and 24 weeks
|
time in light activity
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8 and 24 weeks
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7-day accelerometry
Time Frame: 8 and 24 weeks
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time in moderate activity
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8 and 24 weeks
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7-day accelerometry
Time Frame: 8 and 24 weeks
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time in vigorous activity
|
8 and 24 weeks
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7-day accelerometry
Time Frame: 8 and 24 weeks
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time in very vigorous activity
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8 and 24 weeks
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7-day accelerometry
Time Frame: 8 and 24 weeks
|
METS
|
8 and 24 weeks
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7-day accelerometry
Time Frame: 8 and 24 weeks
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sedentary bouts
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8 and 24 weeks
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24-hour ABPM
Time Frame: 8 and 24 weeks
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daytime, night time systolic and diastolic BP
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8 and 24 weeks
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Adherence
Time Frame: 8 and 24 weeks
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70% of in centre sessions attended and 70% of home sessions performed prescribed (accelerometry and log book)
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8 and 24 weeks
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Body cell mass
Time Frame: 8 and 24 weeks
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Body composition using bioimpedance spectroscopy
|
8 and 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Thompson, MD PhD, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00078564
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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