Intra Hemodialytic Oral Protein and Exercise (IHOPE) (IHOPE)
|ClinicalTrials.gov Identifier: NCT01234441|
Recruitment Status : Unknown
Verified December 2015 by Kenneth Wilund, University of Illinois at Urbana-Champaign.
Recruitment status was: Active, not recruiting
First Posted : November 4, 2010
Last Update Posted : December 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Diseases||Dietary Supplement: Control Dietary Supplement: Protein Behavioral: Protein + Exercise||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Intradialytic Protein Supplementation & Exercise Training in Dialysis Patients.|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||December 2016|
Sham Comparator: Control
This group of patients will receive a non-nutritive beverage, and no exercise.
Dietary Supplement: Control
A placebo non-nutritive beverage will be administered before dialysis sessions 3 times per week.
Active Comparator: Protein
This group of patients will ingest 30 grams of a liquid whey protein supplement during the first hour of their dialysis session
Dietary Supplement: Protein
A whey protein beverage will be administered before dialysis sessions 3 times per week.
Active Comparator: Protein + Exercise
This group will ingest 30 grams of a liquid whey protein supplement as well as exercise for 30-45 minutes during their dialysis treatment
Behavioral: 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.
- Examine the effects of intradialytic oral protein supplementation and exercise training on physical function. [ Time Frame: 12 months ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|