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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61HL178691 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | Participants receive CKD education plus a 12-week cardiac rehabilitation-based lifestyle program including supervised exercise, DASH-based diet counseling, and weight management. |
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| Usual Care | Active Comparator | Participants receive CKD education only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component lifestyle intervention | Behavioral | Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in DASH diet adherence score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystal Tyson, MD | Contact | 919-660-6860 | crystal.simpson@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Crystal Tyson, M.D. | Duke University | Principal Investigator |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Usual Care Control | Behavioral | Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription |
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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 | 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 | 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) | 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) | 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) | 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |