Kidney FailureACE-HDNCT02753868
Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients
A study testing exercise and Hemodialysis treatment in people with Kidney Failure, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a crossover design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- exercise and Hemodialysis treatment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
Who cannot join
- Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a crossover design.
Read the detailed description
Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high rates, despite advances in HD techniques and pharmacological therapies. This indicates additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during HD treatment) represents a low-cost, easy to administer treatment strategy that could potentially improve cardiovascular function, physical function and quality of life. However, nephrologists rarely counsel their patients to increase their physical activity levels or to exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.
Providing more robust evidence for the safety and effectiveness of IDEX, as well as evaluating the impact of exercising early vs late in the treatment, could help improve adoption of exercise training as a standard practice in HD clinics.
Therefore, investigators plan to examine the impact of IDEX and its timing during treatment (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study also includes various cardiovascular measures to allow deeper mechanistic understanding of cardiovascular physiology with IDEX. Such understanding will significantly advance the field and lead to improved therapeutic approaches, including exercise training, which may help mediate the deleterious effects of renal failure.
- Conditions
- Kidney Failure
- Being tested
- exercise, Hemodialysis treatment
- Keywords
- Intradialytic exercise, Cardiac and arterial function
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
Hemodialysis treatmentProcedure or surgery
Participants will receive a standard hemodialysis treatment during the study period
| Study group | Role | What they receive |
|---|---|---|
| Standard Hemodialysis | Experimental | Participants will be monitored during their normal hemodialysis treatment with no intervention administered Receives: Procedure: Hemodialysis treatment |
| Hemodialysis with Exercise (1-st hr) | Experimental | Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 1-st hour into treatment Receives: Behavioral: exercise; Procedure: Hemodialysis treatment |
| Hemodialysis with Exercise (3-rd hr) | Experimental | Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 3-rd hour into treatment Receives: Behavioral: exercise; Procedure: Hemodialysis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine
Measured: Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
Changes in cardiac output (mL/min) measured by thoracic impedance technique
Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.
Measured: Continous throughout a dialysis treatment (approximately 4 hours)
Secondary outcomes (2)
Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
A finger cuff will be placed around the non-dialyzing finger and will measure the change in peripheral blood pressure from successive beats continuously. Total peripheral resistance will be estimated using measured cardiac output and peripheral blood pressure.
Measured: Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
Hypotensive event assessment measured by a symptom questionnaire
The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.
Measured: Throughout and up to 5 hours after completion of a dialysis treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Wilund, University of Illinois at Urbana-Champaign
- Investigators
- Kenneth Wilund, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753868
- Sponsor's protocol ID
- 15691
- Acronym
- ACE-HD
- Status last verified
- Mar 2017
- First submitted
- 27 Feb 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35018639
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02753868
- Acronym / sponsor ID
- ACE-HD / 15691
- Conditions
- Kidney Failure
- Keywords
- Intradialytic exercise, Cardiac and arterial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Apr 2016 (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.
The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a crossover design.
Detailed description
Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high rates, despite advances in HD techniques and pharmacological therapies. This indicates additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during HD treatment) represents a low-cost, easy to administer treatment strategy that could potentially improve cardiovascular function, physical function and quality of life. However, nephrologists rarely counsel their patients to increase their physical activity levels or to exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.
Providing more robust evidence for the safety and effectiveness of IDEX, as well as evaluating the impact of exercising early vs late in the treatment, could help improve adoption of exercise training as a standard practice in HD clinics.
Therefore, investigators plan to examine the impact of IDEX and its timing during treatment (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study also includes various cardiovascular measures to allow deeper mechanistic understanding of cardiovascular physiology with IDEX. Such understanding will significantly advance the field and lead to improved therapeutic approaches, including exercise training, which may help mediate the deleterious effects of renal failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Hemodialysis | Experimental | Procedure: Hemodialysis treatmentParticipants will be monitored during their normal hemodialysis treatment with no intervention administered |
| Hemodialysis with Exercise (1-st hr) | Experimental | Behavioral: exercise, Procedure: Hemodialysis treatmentParticipants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 1-st hour into treatment |
| Hemodialysis with Exercise (3-rd hr) | Experimental | Behavioral: exercise, Procedure: Hemodialysis treatmentParticipants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 3-rd hour into treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists
Key exclusion criteria (1 listed)
- Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.
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 |
|---|---|---|
| exerciseParticipants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment | Behavioural | Hemodialysis with Exercise (1-st hr), Hemodialysis with Exercise (3-rd hr) |
| Hemodialysis treatmentParticipants will receive a standard hemodialysis treatment during the study period | Procedure or surgery | Hemodialysis with Exercise (1-st hr), Hemodialysis with Exercise (3-rd hr), Standard Hemodialysis |
Primary outcome
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
Time frame: Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine
Changes in cardiac output (mL/min) measured by thoracic impedance technique
Time frame: Continous throughout a dialysis treatment (approximately 4 hours)
Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.
2 secondary outcomes
Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
Time frame: Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
Hypotensive event assessment measured by a symptom questionnaire
Time frame: Throughout and up to 5 hours after completion of a dialysis treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Derived from this study: PubMed 35018639Bernier-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.
- Individual participant dataSharing planned: No
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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
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and Hemodialysis treatment in people with Kidney Failure, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Mar 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment (time frame: Every 15 minutes throughout each dialysis treatment (approximately 4 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753868, which also lists 1 linked publication.
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 7 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.