Multi-component lifestyle intervention
BehavioralCardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.
NCT Number: NCT07633145
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.
Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription
Time frame: 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.
Time frame: Baseline, 3 months, 9 months
Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Duke University
Other
Multi-component Lifestyle Intervention to Improve Outcomes in Chronic Kidney Disease
Acronym: CKD-LIFE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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