Recruiting

Healthy Lifestyle Program

Sponsor:

Duke University

Code:

NCT07633145

Conditions

Chronic Kidney Disease

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Multi-component lifestyle intervention

Usual Care Control

Study Details

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.

Conditions

Chronic Kidney Disease

Hypertension

Study ID

NCT07633145

Start date

Jul 30, 2026

Status verified date

May, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Usual Care

Participants receive CKD education only.

Interventions

Multi-component lifestyle intervention

Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.

Usual Care Control

Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription

Primary outcome measure

  • Change in clinic systolic blood pressure (SBP) [ Time Frame: Baseline, 3 months, 9 months ]

Central Contacts and Locations

Central contacts

Crystal Tyson, MD

919-660-6860crystal.simpson@duke.edu

Locations

Sarah W Stedman Nutrition & Metabolism Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Susanne Danus

919-681-4453susanne.danus@duke.edu

Heather Taylor

919-684-5671heather.l.taylor@duke.edu

Principal Investigator:

Crystal C Tyson, MD, MHS

More Information

Sponsor

Duke University

Last update posted

Sep 22, 2026

Last verified

May, 2026

Keywords

  • chronic kidney disease
  • blood pressure
  • lifestyle intervention
  • diet
  • exercise
  • weight management
  • cardiac rehabilitation
  • hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.