Functional Electrical Stimulation (FES) Exercise Training in Hemodialysis Patients

NCT01956214 | Terminated

• 1 other identifier: IRB#: 12309
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Both strength training and endurance exercise training are commonly prescribed to improve strength and function in patients with physical limitations caused by chronic disease or disability including chronic kidney disease (CKD). Individuals with CKD often have low physical function due to progressive declines in the performance of their kidneys. The low physical function leads to physical inactivity, which exacerbates these functional declines and promotes cardiovascular disease and bone disorders. In addition, severe functional limitations in some patients prevent them from exercising at a great enough intensity to provide significant benefits. As a result, alternative strategies are needed to maximize the benefits of exercise while decreasing injury risk.

Conditions

Complication of Dialysis

Keywords

hemodialysis; exercise; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• physical function

  muscle strength, functional fitness testing, shuttle walk test, balance and gait kinematics

  Three months

Other Outcomes (3)

• quality of life (QOL)

  three months

• heart disease

  three months

• bone health

  three months

Study Arms (2)

FES exercise

EXPERIMENTAL

Participants will receive FES

Other: FES Exercise

Mock FES exercise

SHAM COMPARATOR

participant will receive Mock FES

Other: Mock FES Exercise

Interventions

FES Exercise OTHER

receive FES while exercising

FES exercise

Mock FES Exercise OTHER

participants will receive Mock FES

Mock FES exercise

Eligibility Criteria

• Age: 31 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 31-85 years
• Must receive hemodialysis treatment at least 3 days per week
• Must be willing to be randomized to the control or FES-cycle groups
• Must receive medical clearance from a Nephrologist at their dialysis clinic to participate

You may not qualify if:

• On dialysis treatment for less than 3 months.
• Body weight of greater than 400 pounds. (weight limitations on the DXA table)
• Unstable angina, recent (less than 3 months) myocardial infarction or stroke (these conditions may not enable the patient to tolerate the proposed exercise training).
• Implanted electronic pacing or defibrillation device, vagus nerve stimulator, or unstable vital signs.(the safety of electrical stimulation under these conditions is not known).
• Metal implants underneath or near the muscle groups which are to be stimulated.
• Pregnancy (the safety of stimulation during pregnancy is not known) - a section on the ICD has been created for women to initial to indicate they are NOT pregnant or planning on becoming pregnant over the course of the study.
• Lower limb amputation.
• On the PAR-Q form, if the participant answers YES to the question: "Has your doctor ever said that you have a heart condition and that you should only do physical activity recommended by a doctor?", they will be excluded from the study.
• Question 1: "Do you ever get chest pains while at rest and/or during exertion?", and Question 4: "…was your heart attack within the last year?" An answer of YES to either question will require that the individual obtain a comprehensive physical exam by their physician prior to being allowed to participate.
• Question 10: Has your physician ever specifically told you not to do "heavy" or "hard" exercise? An answer of YES will require a physical exam.
• Under "Medical History" (top of page 2 of Medical History Form), or "Present Symptoms Review" (top of page 3) a check by "chest pain or pressure" will require a physical exam.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

Champaign Urbana Dialysis Center

Urbana, Illinois, 61801, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kenneth Wilund, PhD

  UIUC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: October 8, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2016
• Last Updated: September 20, 2017

Record last verified: 2014-08

Locations

US (1)