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Not yet recruiting NCT07633145

Lifestyle Intervention In CKD

No phase Interventional Chronic Kidney Disease Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-component lifestyle intervention, Usual Care Control.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease, Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Change in clinic systolic blood pressure (SBP) [Time frame: Baseline, 3 months, 9 months]
Secondary outcome measures (7)
  • Change in DASH diet adherence score [Time frame: Baseline, 3 months, 9 months]
  • Change in 24-hour urinary sodium-to-potassium ratio [Time frame: Baseline, 3 months, 9 months]
  • Change in 6-minute walk test [Time frame: Baseline, 3 months, 9 months]
  • Change in 24-hour urine albumin excretion [Time frame: Baseline, 3 months, 9 months]
  • Change in clinic diastolic blood pressure (DBP) [Time frame: Baseline, 3 months, 9 months]
  • Change in 24-hour systolic blood pressure (SBP) [Time frame: Baseline, 3 months, 9 months]
  • Change in 24-hour diastolic blood pressure (DBP) [Time frame: Baseline, 3 months, 9 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07633145 · PRO00118256 · 1R61HL178691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗