Intra Hemodialytic Oral Protein and Exercise (IHOPE)
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.
Dietary Supplement: Control
Dietary Supplement: Protein
Other: Protein + Exercise
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Intradialytic Protein Supplementation & Exercise Training in Dialysis Patients.|
- Examine the effects of intradialytic oral protein supplementation and exercise training on physical function. [ Time Frame: 12 months ] [ Designated as safety issue: No ]Physical function, as assessed by a shuttle walk test, will improve in PRO+EX and PRO, compared to CON, and the magnitude of improvements will be greatest in PRO+EX. In secondary analyses, we also will examine the effects of our interventions on other variables related to physical function, including lean body mass, muscle strength, and activities of daily living (ADL) assessments.
- Examine the effects of intradialytic oral protein supplementation and exercise training on CVD risk. [ Time Frame: 12 months ] [ Designated as safety issue: No ]CVD risk, as assessed by carotid artery stiffness, will improve in PRO+EX and PRO, compared to CON, and the magnitude of improvements will be greatest in PRO+EX. In secondary analyses, we also will examine the effects of our interventions on other factors related to CVD risk, including carotid IMT, myocardial performance, LVH, aortic calcification, and epicardial fat levels.
- Examine the effects of intradialytic oral protein supplementation and exercise training on bone health as determined by bone mineral density (BMD). [ Time Frame: 12 months ] [ Designated as safety issue: No ]BMD will be reduced significantly more in CON than in PRO+EX or PRO. We anticipate that BMD will remain stable in PRO+EX or PRO. Because the exercise is not bone loading (i.e., invoking ground or joint reaction forces), we do not expect additive effects of PRO+EX on BMD.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Dialysis Patients
This is the group of patients who will receive the interventions of either control non-nutritive beverage, whey protein beverage or beverage protein + exercise.
Dietary Supplement: Control
A placebo non-nutritive beverage will be administered before dialysis sessions 3 times per week.Dietary Supplement: Protein
A whey protein beverage will be administered before dialysis sessions 3 times per week.Other: Protein + Exercise
A whey protein beverage will be administered before dialysis sessions 3 times per week. Patients will also exercise by stationary bicycle during dialysis sessions 3 times per week.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234441
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|University of Illinois at Urbana-Champaign|
|Urbana, Illinois, United States, 61801|
|Principal Investigator:||Kenneth R Wilund, Ph.D.||University of Illinois at Urbana-Champaign|