Multi-component Lifestyle Intervention to Improve Outcomes in Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 152
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Lifestyle Intervention
Participants receive CKD education plus a 12-week cardiac rehabilitation-based lifestyle program including supervised exercise, DASH-based diet counseling, and weight management.
Intervention: Multi-component lifestyle intervention (Behavioral)
Usual Care
Participants receive CKD education only.
Intervention: Usual Care Control (Behavioral)