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Lifestyle Intervention In CKD: Randomized Controlled Trial (CKD-LIFE)

2. juni 2026 opdateret af: Duke University

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

152

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Multi-component lifestyle intervention
Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.
Aktiv komparator: Usual Care
Participants receive CKD education only.
Adfærdsmæssigt: Usual Care Control
Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in clinic systolic blood pressure (SBP)
Tidsramme: 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.
Baseline, 3 months, 9 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in DASH diet adherence score
Tidsramme: Baseline, 3 months, 9 months
Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Baseline, 3 months, 9 months
Change in 24-hour urinary sodium-to-potassium ratio
Tidsramme: 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
Baseline, 3 months, 9 months
Change in 6-minute walk test
Tidsramme: 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.
Baseline, 3 months, 9 months
Change in 24-hour urine albumin excretion
Tidsramme: 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).
Baseline, 3 months, 9 months
Change in clinic diastolic blood pressure (DBP)
Tidsramme: 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.
Baseline, 3 months, 9 months
Change in 24-hour systolic blood pressure (SBP)
Tidsramme: 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.
Baseline, 3 months, 9 months
Change in 24-hour diastolic blood pressure (DBP)
Tidsramme: 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.
Baseline, 3 months, 9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

  • Ledende efterforsker: Crystal Tyson, M.D., Duke University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

14. juli 2026

Primær færdiggørelse (Anslået)

30. juni 2029

Studieafslutning (Anslået)

30. juni 2030

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PRO00118256
  • 1R61HL178691 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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