Lifestyle Intervention In CKD

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07633145 · PRO00118256 · 1R61HL178691

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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