Lifestyle Intervention In CKD

NCT07633145 | Not Yet Recruiting DMC

• 2 other identifiers: PRO001182561R61HL178691
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in clinic systolic blood pressure (SBP)

  Three BP values obtained one minute apart will be obtained and averaged to define clinic BP for that time point.

  Baseline, 3 months, 9 months

Secondary Outcomes (7)

• Change in DASH diet adherence score

  Baseline, 3 months, 9 months

• Change in 24-hour urinary sodium-to-potassium ratio

  Baseline, 3 months, 9 months

• Change in 6-minute walk test

  Baseline, 3 months, 9 months

• Change in 24-hour urine albumin excretion

  Baseline, 3 months, 9 months

• Change in clinic diastolic blood pressure (DBP)

  Baseline, 3 months, 9 months

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

Participants receive CKD education plus a 12-week cardiac rehabilitation-based lifestyle program including supervised exercise, DASH-based diet counseling, and weight management.

Behavioral: Multi-component lifestyle intervention

Usual Care

ACTIVE COMPARATOR

Participants receive CKD education only.

Behavioral: Usual Care Control

Interventions

Multi-component lifestyle intervention BEHAVIORAL

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

Lifestyle Intervention

Usual Care Control BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Crystal Tyson, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Tyson, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 14, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share