Complication of DialysisNCT01956214
Functional Electrical Stimulation (FES) Exercise Training in Hemodialysis Patients
A study testing FES Exercise and Mock FES Exercise in people with Complication of Dialysis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 31 to 85 years
- Conditions the study is for
- Complication of Dialysis
- What is being tested?
- FES Exercise and Mock FES Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Must have evidence of impaired mobility on the FES Screening Form, attached. The FES Screening Form inclusion criterion consist of a questionnaire of five tasks with a relative difficulty scale for the completion of each task. Participants will be included in the study if they indicate "some" or more difficulty at any task on the questionnaire.
Who cannot join
- 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.
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- 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.
- We will also use answers on the Medical History Form to help us evaluate the exclusion criteria. Answers to the following questions will either be exclusionary, or require further follow-up with a physician prior to being allowed to participate:
- 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.
- Under "Present Symptoms Review (top of page 3), a check by any of the following will lead to exclusion: Implanted electronic pacing or defibrillation device; vagus nerve stimulator; metal implants in the legs; or unstable vital signs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Champaign Urbana Dialysis Center
Urbana, Illinois, 61801
About this study
Official title: Efficacy of Functional Electrical Stimulation Exercise Training in Hemodialysis Patients
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.
Read the detailed description
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.
A new form of exercise, functional electrical stimulation (FES)-enhanced cycling has been shown to increase muscle size and strength in patients with severe disabilities, particularly spinal cord injury (SCI). It is based on the application of electrical stimulation to the nerves that innervate the paralyzed weak muscles in order to generate muscle contraction. FES has been used to stimulate leg muscles to pedal a cycle or to enable partial weight-supported walking as an activity based rehabilitation therapy. FES cycling involves exercising using a motor-assisted cycle coupled with electrical stimulation to up to five muscles in the leg. There are well-documented benefits of FES-induced exercise in SCI patients including clinically significant increases in muscle mass, blood flow, bone density, and bowel and bladder function. A few pilot studies have also demonstrated that FES therapy has the potential to improve function in other disabled populations, including chronic heart failure and stroke patients. However, its effects in other populations with significant physical impairments, including CKD patients, have yet to be established.
The objective of the proposed research is to evaluate the effects of FES-cycling training on measures related to physical function, quality of life (QOL), heart disease, and bone health in patients with renal failure receiving dialysis therapy.
- Conditions
- Complication of Dialysis
- Being tested
- FES Exercise, Mock FES Exercise
- Keywords
- hemodialysis, exercise, electrical stimulation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES ExerciseOther
receive FES while exercising
Mock FES ExerciseOther
participants will receive Mock FES
| Study group | Role | What they receive |
|---|---|---|
| FES exercise | Experimental | Participants will receive FES Receives: Other: FES Exercise |
| Mock FES exercise | Sham comparator | participant will receive Mock FES Receives: Other: Mock FES Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical function
muscle strength, functional fitness testing, shuttle walk test, balance and gait kinematics
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionNov 2016
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Wilund, PhD, Principal investigator, UIUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956214
- Sponsor's protocol ID
- IRB#: 12309
- Status last verified
- Aug 2014
- First submitted
- 17 Apr 2013
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Functional Electrical Stimulation Exercise Training in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01956214
- Acronym / sponsor ID
- IRB#: 12309
- Conditions
- Complication of Dialysis
- Keywords
- hemodialysis, exercise, electrical stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
A new form of exercise, functional electrical stimulation (FES)-enhanced cycling has been shown to increase muscle size and strength in patients with severe disabilities, particularly spinal cord injury (SCI). It is based on the application of electrical stimulation to the nerves that innervate the paralyzed weak muscles in order to generate muscle contraction. FES has been used to stimulate leg muscles to pedal a cycle or to enable partial weight-supported walking as an activity based rehabilitation therapy. FES cycling involves exercising using a motor-assisted cycle coupled with electrical stimulation to up to five muscles in the leg. There are well-documented benefits of FES-induced exercise in SCI patients including clinically significant increases in muscle mass, blood flow, bone density, and bowel and bladder function. A few pilot studies have also demonstrated that FES therapy has the potential to improve function in other disabled populations, including chronic heart failure and stroke patients. However, its effects in other populations with significant physical impairments, including CKD patients, have yet to be established.
The objective of the proposed research is to evaluate the effects of FES-cycling training on measures related to physical function, quality of life (QOL), heart disease, and bone health in patients with renal failure receiving dialysis therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES exercise | Experimental | Other: FES ExerciseParticipants will receive FES |
| Mock FES exercise | Sham comparator | Other: Mock FES Exerciseparticipant will receive Mock FES |
Who may qualify
- Ages
- 31 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Must have evidence of impaired mobility on the FES Screening Form, attached. The FES Screening Form inclusion criterion consist of a questionnaire of five tasks with a relative difficulty scale for the completion of each task. Participants will be included in the study if they indicate "some" or more difficulty at any task on the questionnaire.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES Exercisereceive FES while exercising | Other | FES exercise |
| Mock FES Exerciseparticipants will receive Mock FES | Other | Mock FES exercise |
Primary outcome
physical function
Time frame: Three months
muscle strength, functional fitness testing, shuttle walk test, balance and gait kinematics
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Wilund, PhD principal investigator
UIUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES Exercise and Mock FES Exercise in people with Complication of Dialysis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical function (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.