Physical Activity in Renal Disease (PAIRED): The Effect on Hypertension
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|ClinicalTrials.gov Identifier: NCT03551119|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : January 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases||Behavioral: Exercise Other: Enhanced usual care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||In this parallel arm control trial, participants recruited from outpatient CKD clinics in Alberta Kidney Care North, Edmonton, Alberta, Canada will be randomized (1:1) to enhanced usual care (measurement of physical activity levels) or an exercise intervention.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Due to the nature of the intervention, participants cannot be blinded to group assignment; however, the primary outcome is objectively measured (24-hour ambulatory blood pressure measurement). For main trial secondary outcomes, assessors will be blinded to allocation status.|
|Official Title:||Physical Activity in Renal Disease (PAIRED): A Randomized Controlled Trial of the Effect on Hypertension|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||September 2021|
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
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.
Other: Enhanced usual care
See previous description
- 24-hour ambulatory SBP [ Time Frame: 8 weeks ]mean 24-hour ambulatory systolic blood pressure
- antihypertensive use [ Time Frame: 8 and 24 weeks ]Using the assigned DDD (WHO) for that drug
- 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
- IPAQ-SF [ Time Frame: 8 and 24 weeks ]International Physical Activity Questionnaire - Short Form
- SEE scale [ Time Frame: 8 and 24 weeks ]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.
- EQ-5D [ Time Frame: 8 and 24 weeks ]European Quality of Life (EuroQOL) health questionnaire with 5 dimensions
- pulse wave velocity [ Time Frame: 8 and 24 weeks ]measurement of aortic stiffness (femoral carotid, radial carotid)
- body mass index [ Time Frame: 8 and 24 weeks ]calculated as weight in kilograms divided by height in meters squared
- Fat mass [ Time Frame: 8 and 24 weeks ]Body composition using bioimpedance spectroscopy
- clinic blood pressure [ Time Frame: 8 and 24 weeks ]with a oscillometric sphygmomanometer
- Oxygen uptake (VO2 peak) [ Time Frame: 8 and 24 weeks ]Cardiopulmonary exercise testing
- estimated glomerular filtration rate [ Time Frame: 8 and 24 weeks ]
- c-reactive protein [ Time Frame: 8 and 24 weeks ]
- total cholesterol [ Time Frame: 8 and 24 weeks ]
- LDL [ Time Frame: 8 and 24 weeks ]
- HDL [ Time Frame: 8 and 24 weeks ]
- triglycerides [ Time Frame: 8 and 24 weeks ]
- HgA1C [ Time Frame: 24 weeks ]glycated hemoglobin
- spot urinary sodium [ Time Frame: 8 and 24 weeks ]measured on a non-exercise day
- spot urinary protein [ Time Frame: 8 and 24 weeks ]measured on a non-exercise day
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]number of steps
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]sedentary time
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]time in light activity
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]time in moderate activity
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]time in vigorous activity
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]time in very vigorous activity
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]METS
- 7-day acclerometry [ Time Frame: 8 and 24 weeks ]sedentary bouts
- 24-hour ABPM [ Time Frame: 8 and 24 weeks ]daytime, night time systolic and diastolic BP
- Adherence [ Time Frame: 8 and 24 weeks ]70% of in centre sessions attended and 70% of home sessions performed prescribed (accelerometry and log book)
- Body cell mass [ Time Frame: 8 and 24 weeks ]Body composition using bioimpedance spectroscopy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551119
|Contact: Sue Szigetyfirstname.lastname@example.org|
|Contact: Nancy Ruhollemail@example.com|
|Royal Alexandra Hospital||Recruiting|
|Edmonton, Alberta, Canada, T5H 3V9|
|Contact: Stephanie E Thompson 7809079902 firstname.lastname@example.org|
|University of Alberta Hospital, outpatient dialysis unit||Recruiting|
|Edmonton, Alberta, Canada, T6G 2P4|
|Contact: Susan Szigety 780-407-7868 email@example.com|
|Grey Nuns Hospital||Recruiting|
|Edmonton, Alberta, Canada, T6L5X8|
|Contact: Stephanie E Thompson 7809079902 firstname.lastname@example.org|