Optimizing Cardiovascular Health and Physical Function in Hemodialysis Patients Through Volume Control and Exercise
Completed · Not applicable
Conditions studied: Renal Failure
In brief
This is a 12 month randomized clinical trial in which patients with renal failure undergoing maintenance hemodialysis (MHD) therapy will be placed on a volume reduction protocol that includes a novel low sodium dietary education program mediated by a lifestyle interventionist with significant collaboration from the existing clinic staff. Participating patients will be randomized to receive: 1) the volume control protocol alone (VC), or 2) the volume control protocol + physical activity and exercise counseling (VCE) from the lifestyle interventionist (LI). A research dietitian (RD), working in collaboration with the existing clinic RD, will develop a program to immerse clinics in a culture of sodium restriction. The research RD will train the LI and other clinic staff (nurses, technicians, etc) to help disseminate this program, modeled after the clinic-wide dissemination approach used in Izmir, Turkey (Dr. Ercan Ok). In addition, the LI will provide exercise and physical activity counseling to the participants randomized to the exercise group, utilizing a SCT-based approach. The Investigators hypothesize that mean arterial pressure will be reduced, and physical function increased, in all patients at 12 months, but the magnitude of these improvements will be greater in the VCE group.
Key facts
- Study ID
- NCT02627066
- Run by
- University of Illinois at Urbana-Champaign
- People needed
- 37
- Starts
- 2015-12-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2018-08-02
Who can join
Age: 20 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Any patient with a blood pressure > 130/85, or prescribed at least one anti-hypertensive medication
You may not qualify if…
- Patients already below their prescribed dry weights and who are normotensive in the absence of hypertensive medications, and without peripheral edema
Where it is running
- University of Illinois at Urbana-Champaign — Urbana, Illinois, United States
Full record on ClinicalTrials.gov
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