Intra Hemodialytic Oral Protein and Exercise (IHOPE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Illinois at Urbana-Champaign
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Kenneth Wilund, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT01234441
First received: November 2, 2010
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention
Kidney Diseases
Dietary Supplement: Control
Dietary Supplement: Protein
Other: Protein + Exercise

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University of Illinois at Urbana-Champaign:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 chronic heart failure (CHF).
  • On dialysis treatment for < 3 months (or enrollment may be postponed).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234441

Contacts
Contact: Kenneth R Wilund, Ph.D. 217-265-6755 kwilund@illinois.edu
Contact: Kristin Wiens, M.S., R.D. 217-300-5225 kwiens@illinois.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Elizabeth Jeanes, M.S.    920-344-9605    elizj@uic.edu   
Principal Investigator: Ken Wilund, Ph.D.         
University of Illinois at Urbana-Champaign Recruiting
Urbana, Illinois, United States, 61801
Contact: Kristin Wiens, M.Sc., R.D.    217-300-5225    kwiens@illinois.edu   
Principal Investigator: Ken Wilund, Ph.D.         
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
University of Illinois at Chicago
Investigators
Principal Investigator: Kenneth R Wilund, Ph.D. University of Illinois at Urbana-Champaign
  More Information

No publications provided

Responsible Party: Kenneth Wilund, Prinicipal Responsiple Investigator, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01234441     History of Changes
Other Study ID Numbers: 1 RO1 DK084016-01
Study First Received: November 2, 2010
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 01, 2014