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NCT Number: NCT07633145

Lifestyle Intervention In CKD

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in clinic systolic blood pressure (SBP)

    Time frame: 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 outcomes

  1. Change in DASH diet adherence score

    Time frame: Baseline, 3 months, 9 months

    Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool

  2. Change in 24-hour urinary sodium-to-potassium ratio

    Time frame: 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

  3. Change in 6-minute walk test

    Time frame: 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.

  4. Change in 24-hour urine albumin excretion

    Time frame: 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).

  5. Change in clinic diastolic blood pressure (DBP)

    Time frame: 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.

  6. Change in 24-hour systolic blood pressure (SBP)

    Time frame: 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.

  7. Change in 24-hour diastolic blood pressure (DBP)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Crystal Tyson, MD

CONTACT

[email protected]

919-660-6860

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: CKD-LIFE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 8, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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