Health TrialsbyHealthPanel

Lifestyle Intervention In CKD

ConditionsChronic Kidney DiseaseHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multi-component lifestyle intervention

    Behavioral

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

  • Usual Care Control

    Behavioral

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

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Lifestyle InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline, 3 months, 9 months

Secondary outcomes

1

Change in DASH diet adherence score

Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool

Time frame
Baseline, 3 months, 9 months
2

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

one 24-hour urine sample will be collected to objectively assess diet adherence to the DASH diet using biomarkers, such as sodium and potassium

Time frame
Baseline, 3 months, 9 months
3

Change in 6-minute walk test

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.

Time frame
Baseline, 3 months, 9 months
4

Change in 24-hour urine albumin excretion

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).

Time frame
Baseline, 3 months, 9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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