Optimizing Cardiovascular Health and Physical Function in Hemodialysis Patients Through Volume Control and Exercise

NCT02627066 | Completed

• 1 other identifier: 14072
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12 month randomized clinical trial in which patients with renal failure undergoing maintenance hemodialysis (MHD) therapy will be placed on a volume reduction protocol that includes a novel low sodium dietary education program mediated by a lifestyle interventionist with significant collaboration from the existing clinic staff. Participating patients will be randomized to receive: 1) the volume control protocol alone (VC), or 2) the volume control protocol + physical activity and exercise counseling (VCE) from the lifestyle interventionist (LI). A research dietitian (RD), working in collaboration with the existing clinic RD, will develop a program to immerse clinics in a culture of sodium restriction. The research RD will train the LI and other clinic staff (nurses, technicians, etc) to help disseminate this program, modeled after the clinic-wide dissemination approach used in Izmir, Turkey (Dr. Ercan Ok). In addition, the LI will provide exercise and physical activity counseling to the participants randomized to the exercise group, utilizing a SCT-based approach. The Investigators hypothesize that mean arterial pressure will be reduced, and physical function increased, in all patients at 12 months, but the magnitude of these improvements will be greater in the VCE group.

Conditions

Renal Failure

Keywords

Exercise; Nutrition; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Volume Overload

  Bioelectrical Impedance Determined Extracellular Hydration status

  6 months

Secondary Outcomes (5)

• Blood Pressure

  monthly for 6 months

• Blood Pressure Medication use

  0 and 6 months

• Stroke Volume

  0 and 6 months

• Treatment Compliance

  0 and 6 months

• Dietary sodium intake

  0 and 6 months

Study Arms (2)

Volume Control

ACTIVE COMPARATOR

This group of patients will receive a volume reduction protocol that includes two primary components: 1) persistent ultrafiltration to slowly reduce patient's post-dialysis weight; and 2) persistent dietary education focused on reducing intake of dietary sodium and phosphorus additives

Behavioral: Volume Control

Volume Control + Exercise

ACTIVE COMPARATOR

This group of patients will receive the volume control intervention in addition to intensive counseling to increase their physical activity levels.

Behavioral: Volume Control + Exercise

Interventions

Volume Control BEHAVIORAL

Persistent reduction in post-dialysis weight and dietary sodium restriction

Volume Control

Volume Control + Exercise BEHAVIORAL

Volume reduction intervention and comprehensive exercise counseling

Volume Control + Exercise

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with a blood pressure \> 130/85, or prescribed at least one anti-hypertensive medication

You may not qualify if:

• Patients already below their prescribed dry weights and who are normotensive in the absence of hypertensive medications, and without peripheral edema

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kenneth R Wilund, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 10, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

US (1)