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Lifestyle Intervention In CKD

Multi-component Lifestyle Intervention to Improve Outcomes in Chronic Kidney Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a 12-week healthy lifestyle program can lower blood pressure and improve kidney health in Black adults with advanced chronic kidney disease. By chance, participants will get either usual kidney health education or a program with healthy eating advice, supervised exercise, and wellness coaching at a heart rehab center.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Black adults age 18 or older.
  • Have a history of high blood pressure.
  • Have an average top blood pressure number of at least 120 or bottom number of at least 80 at screening, based on three readings.
  • Have no changes to blood pressure medicines in the 4 weeks before joining.
  • Have an eGFR of 15–44 at screening. This test shows how well the kidneys filter blood.
  • Agree to be placed in either study group by chance.

Who can't join

  • Are on dialysis or need it; have had or need a kidney transplant; or have a sudden kidney injury at screening.
  • Have an average top blood pressure number of 180 or higher or bottom number of 110 or higher at screening; or have an unusually high top number during exercise testing, such as over 210 for men or 190 for women.
  • Are underweight, with a body mass index (BMI) below 18.5; plan weight loss surgery within 1 year; or had gastric bypass surgery in the past 2 years.
  • Score 27 or higher on a survey about taking blood pressure medicine as directed.
  • Have a serious heart condition that prevents exercise, severe asthma, or severe long-term lung disease.
  • Have muscle, bone, joint, or nerve conditions that prevent exercise; or have physical limits, unsteady walking, or a need for constant support that staff think would make treadmill testing unsafe.
  • Have a major mental health disorder, abuse illegal drugs, or drink more than 14 alcoholic drinks per week for men or 7 for women.
  • Are pregnant or plan pregnancy within 1 year; or have another illness that limits how long you may live, such as cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC