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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
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Stephanie Thompson, University of Alberta

Brief Summary:

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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.

Behavioral: Exercise
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




Primary Outcome Measures :
  1. 24-hour ambulatory SBP [ Time Frame: 8 weeks ]
    mean 24-hour ambulatory systolic blood pressure


Secondary Outcome Measures :
  1. antihypertensive use [ Time Frame: 8 and 24 weeks ]
    Using the assigned DDD (WHO) for that drug

  2. 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

  3. IPAQ-SF [ Time Frame: 8 and 24 weeks ]
    International Physical Activity Questionnaire - Short Form

  4. 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.

  5. EQ-5D [ Time Frame: 8 and 24 weeks ]
    European Quality of Life (EuroQOL) health questionnaire with 5 dimensions

  6. pulse wave velocity [ Time Frame: 8 and 24 weeks ]
    measurement of aortic stiffness (femoral carotid, radial carotid)

  7. body mass index [ Time Frame: 8 and 24 weeks ]
    calculated as weight in kilograms divided by height in meters squared

  8. Fat mass [ Time Frame: 8 and 24 weeks ]
    Body composition using bioimpedance spectroscopy

  9. clinic blood pressure [ Time Frame: 8 and 24 weeks ]
    with a oscillometric sphygmomanometer

  10. Oxygen uptake (VO2 peak) [ Time Frame: 8 and 24 weeks ]
    Cardiopulmonary exercise testing

  11. estimated glomerular filtration rate [ Time Frame: 8 and 24 weeks ]
  12. c-reactive protein [ Time Frame: 8 and 24 weeks ]
  13. total cholesterol [ Time Frame: 8 and 24 weeks ]
  14. LDL [ Time Frame: 8 and 24 weeks ]
  15. HDL [ Time Frame: 8 and 24 weeks ]
  16. triglycerides [ Time Frame: 8 and 24 weeks ]
  17. HgA1C [ Time Frame: 24 weeks ]
    glycated hemoglobin

  18. spot urinary sodium [ Time Frame: 8 and 24 weeks ]
    measured on a non-exercise day

  19. spot urinary protein [ Time Frame: 8 and 24 weeks ]
    measured on a non-exercise day

  20. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    number of steps

  21. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    sedentary time

  22. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    time in light activity

  23. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    time in moderate activity

  24. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    time in vigorous activity

  25. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    time in very vigorous activity

  26. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    METS

  27. 7-day acclerometry [ Time Frame: 8 and 24 weeks ]
    sedentary bouts

  28. 24-hour ABPM [ Time Frame: 8 and 24 weeks ]
    daytime, night time systolic and diastolic BP

  29. Adherence [ Time Frame: 8 and 24 weeks ]
    70% of in centre sessions attended and 70% of home sessions performed prescribed (accelerometry and log book)

  30. Body cell mass [ Time Frame: 8 and 24 weeks ]
    Body composition using bioimpedance spectroscopy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resting SBP >130 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 130 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.

Information from the National Library of Medicine

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


Contacts
Contact: Sue Szigety 7804923330 sszigety@ualberta.ca
Contact: Nancy Ruholl 7804923887 nruholl@ualberta.ca

Locations
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Stephanie E Thompson    7809079902    th11@ualberta.ca   
University of Alberta Hospital, outpatient dialysis unit Recruiting
Edmonton, Alberta, Canada, T6G 2P4
Contact: Susan Szigety    780-407-7868    sszigety@ualberta.ca   
Grey Nuns Hospital Recruiting
Edmonton, Alberta, Canada, T6L5X8
Contact: Stephanie E Thompson    7809079902    th11@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Canadian Institutes of Health Research (CIHR)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephanie Thompson, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03551119     History of Changes
Other Study ID Numbers: Pro00078564
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency