Chronic Kidney Disease, Hypertension
Conditions
Keywords
chronic kidney disease, blood pressure, lifestyle intervention, diet, exercise, weight management, cardiac rehabilitation, hypertension
Brief summary
This research study will test whether a 12-week healthy lifestyle program offered through a cardiac rehabilitation center can help lower blood pressure and improve kidney health in adults with advanced chronic kidney disease. Participants will be randomly assigned to either routine kidney health education or take part in a program that includes healthy eating guidance, supervised exercise sessions, and wellness coaching. The goal of the study is to determine whether this program can improve blood pressure and other factors linked to worsening kidney disease.
Detailed description
This single-site randomized controlled trial will evaluate the blood pressure and kidney effects of a 12-week structured, cardiac rehabilitation-based lifestyle intervention in adults with advanced chronic kidney disease. Participants will be randomized to usual care or a multi-component, cardiac rehabilitation center-based lifestyle intervention, including diet modification, supervised exercise, and wellness counseling. The study aims to determine whether the intervention improves systolic blood pressure and related determinants of chronic kidney disease progression.
Interventions
BEHAVIORALMulti-component lifestyle intervention
Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.
BEHAVIORALUsual Care Control
Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription
Sponsors
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Black race; ≥18 years old * history of hypertension * SBP ≥120 or DBP ≥80 mm Hg average of three measurements at screening visit (per KDIGO recommended SBP target of \<120 mm Hg)48 * Stable anti-hypertensive medication regimen (i.e., no medication changes 4 weeks prior to enrollment); * eGFR of 15-44 ml/min/1.73m2 at screening visit * agreeable to randomization to either of the 2 study arms
Exclusion criteria
* currently receiving or needing dialysis; having received or needing a kidney transplant * acute kidney injury at time of screening * average SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg at screening * Exaggerated systolic response during ETT (e.g., SBP \>210 mmHg in men or \>190 mmHg in women) * underweight (BMI \<18.5 kg/m2) * planned weight loss surgery in 1 year * a score of 27 or higher on the BP medication adherence scale * cardiac condition that would preclude participation in aerobic exercise training, including severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at \<85% heart rate reserve on screening treadmill testing), severe heart failure (NYHA Class 3 or 4), high grade arrhythmias, severe valvular heart disease * severe asthma or chronic obstructive lung disease * musculoskeletal or neurologic conditions that would preclude participation in aerobic exercise training * a major psychiatric disorder * illicit drug abuse * current alcohol consumption \>14 drinks/week for men and \>7 drinks/week for women * pregnant or planned pregnancy within 1 year * gastric bypass surgery within the last 2 years * a life-limiting comorbid medical condition, such as cancer. * physical limitation, gait instability, or need for continuous weight-bearing support that, in the opinion of study staff, would prevent safe completion of exercise treadmill testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinic systolic blood pressure (SBP) | Baseline, 3 months, 9 months | Three BP values obtained one minute apart will be obtained and averaged to define clinic BP for that time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in DASH diet adherence score | Baseline, 3 months, 9 months | Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool |
| Change in 24-hour urinary sodium-to-potassium ratio | Baseline, 3 months, 9 months | one 24-hour urine sample will be collected to objectively assess diet adherence to the DASH diet using biomarkers, such as sodium and potassium |
| Change in 6-minute walk test | Baseline, 3 months, 9 months | Participants will be instructed to walk as far as possible for six minutes along a flat, straight course, with standardized encouragement provided at set intervals in accordance with American Thoracic Society guidelines. The total distance walked (in meters) is recorded. |
| Change in 24-hour urine albumin excretion | Baseline, 3 months, 9 months | Urine albumin and creatinine concentrations will be determined from one 24-hour urine collection to assess for albuminuria (or from random sample in the event 24-hour sample cannot be collected). |
| Change in clinic diastolic blood pressure (DBP) | Baseline, 3 months, 9 months | Three BP values obtained one minute apart will be obtained and averaged to define clinic BP for that time point. |
| Change in 24-hour systolic blood pressure (SBP) | Baseline, 3 months, 9 months | Blood pressure monitor will be provided to participants to take home. Monitor will be programmed to take BP measurements every 20-30 minutes during waking hours and every 30-60 minutes during the nighttime sleep period. |
| Change in 24-hour diastolic blood pressure (DBP) | Baseline, 3 months, 9 months | Blood pressure monitor will be provided to participants to take home. Monitor will be programmed to take BP measurements every 20-30 minutes during waking hours and every 30-60 minutes during the nighttime sleep period. |
Contacts
CONTACTCrystal Tyson, MD
PRINCIPAL_INVESTIGATORCrystal Tyson, M.D.
Duke University
Outcome results
None listed