Intra Hemodialytic Oral Protein and Exercise (IHOPE)

NCT01234441 | Completed DMC

• 1 other identifier: 1R01DK084016-01
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Examine the effects of intradialytic oral protein supplementation and exercise training on physical function.

  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.

  12 months

Secondary Outcomes (2)

• Examine the effects of intradialytic oral protein supplementation and exercise training on CVD risk.

  12 months

• Examine the effects of intradialytic oral protein supplementation and exercise training on bone health as determined by bone mineral density (BMD).

  12 months

Study Arms (3)

Control

SHAM COMPARATOR

This group of patients will receive a non-nutritive beverage, and no exercise.

Dietary Supplement: Control

Protein

ACTIVE COMPARATOR

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

Protein + Exercise

ACTIVE COMPARATOR

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

Interventions

Control DIETARY_SUPPLEMENT

A placebo non-nutritive beverage will be administered before dialysis sessions 3 times per week.

Control

Protein DIETARY_SUPPLEMENT

A whey protein beverage will be administered before dialysis sessions 3 times per week.

Protein

Protein + Exercise BEHAVIORAL

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.

Protein + Exercise

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• University of Illinois at Chicago: collaborator

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (2)

• Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

  PMID: 35018639 DERIVED

• Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Kidney Diseases

Interventions

Proteins; Exercise

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kenneth R Wilund, Ph.D.

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Responsiple Investigator

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 4, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

US (2)