Intra Hemodialytic Oral Protein and Exercise (IHOPE)
Completed · Not applicable · Has a placebo group
Conditions studied: Kidney Diseases
In brief
Chronic kidney disease (CKD) patients receiving hemodialysis treatment (CKD stage 5) suffer from a variety of co-morbid diseases, many of which may be mechanistically linked. Protein malnutrition, muscle catabolism and wasting are especially common, and these lead to reduced muscle strength, declines in physical function, and low levels of physical activity. Physical inactivity exacerbates these functional declines, and also promotes cardiovascular disease (CVD) and bone disorders. This cycle of disease and disability greatly reduces quality of life (QOL) and increases mortality rates in dialysis patients. Many factors contribute to the development of these co-morbidities. Chronic inflammation is believed to be a cause and a consequence of the protein malnutrition, CVD and bone disorders in dialysis patients. In addition, abnormalities in mineral metabolism resulting from the deficit in kidney function promote the loss of mineral from bone and the deposition of mineral in the vasculature, a process termed vascular calcification (VC). VC is associated with a variety of CVD-related disorders, including arterial stiffness, increases in arterial wall intima-media thickness (IMT), left ventricular hypertrophy (LVH), and declines in cardiac function. As a result of these abnormalities, cardiovascular events are 10 to 30 times greater in dialysis patients than in age- and sex-matched subjects in the general population.
Key facts
- Study ID
- NCT01234441
- Run by
- University of Illinois at Urbana-Champaign
- People needed
- 138
- Starts
- 2010-12-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2018-08-01
Who can join
Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must receive hemodialysis treatment at least 3 days per week.
- Must be ≥ 30 years of age.
- Must be willing to be randomized to the control or intervention groups.
- Must be physically able to exercise (e.g., no orthopedic problems that would preclude them from cycling during dialysis).
- Must receive medical clearance from their primary care physician to participate.
- Must be on phosphate binders to control calcium levels.
You may not qualify if…
- Persistent hemoglobin levels < 10g/dl.
- Weight greater than 300 pounds.
- Currently receiving any form of intradialytic protein supplementation (oral, enteral, or parenteral) or participating in any form of intradialytic exercise training.
- Chronic obstructive pulmonary disease (COPD) and decompensated chronic heart failure (CHF).
- On dialysis treatment for < 3 months (or enrollment may be postponed).
Where it is running
- University of Illinois at Chicago — Chicago, Illinois, United States
- University of Illinois at Urbana-Champaign — Urbana, Illinois, United States
Full record on ClinicalTrials.gov
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