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RECRUITING Not applicable ClinicalTrials.gov

Lifestyle Intervention In CKD

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07633145

Registry updated: 2026-09-22
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Description

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.

Interventions

  • Multi-component lifestyle intervention (Behavioral)
    Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.
  • Usual Care Control (Behavioral)
    Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription

Eligibility criteria

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

Conditions

Chronic Kidney Disease Hypertension

Locations

  • Sarah W Stedman Nutrition & Metabolism Center — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record