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CompletedNCT02753868ACE-HDUpdated Mar 7, 2017

Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

An interventional study of exercise and Hemodialysis treatment in Kidney Failure, sponsored by University of Illinois at Urbana-Champaign. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-07.

Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Kidney Failure

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Keywords

  • Intradialytic exercise
  • Cardiac and arterial function
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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 12 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

University of Illinois at Urbana-Champaign is the lead sponsor of 188 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists

Exclusion criteria

Exclusion Criteria:

  • Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Standard Hemodialysis

    Participants will be monitored during their normal hemodialysis treatment with no intervention administered

    Procedure: Hemodialysis treatment

  • Experimental
    Hemodialysis with Exercise (1-st hr)

    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

    Behavioral: exercise · Procedure: Hemodialysis treatment

  • Experimental
    Hemodialysis with Exercise (3-rd hr)

    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

    Behavioral: exercise · Procedure: Hemodialysis treatment

Interventions

  • Behavioralexercise

    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

  • ProcedureHemodialysis treatment

    Participants will receive a standard hemodialysis treatment during the study period

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Every 15 minutes throughout each dialysis treatment (approximately 4 hours)

  2. 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.

    Time frame: Continous throughout a dialysis treatment (approximately 4 hours)

Secondary outcomes

  1. 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.

    Time frame: Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week

  2. Hypotensive event assessment measured by a symptom questionnaire

    The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.

    Time frame: Throughout and up to 5 hours after completion of a dialysis treatment

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Study locations

1 site
  • University of Illinois at Urbana-Champaign
    Urbana, Illinois 61801, United States
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02753868
Lead sponsor
University of Illinois at Urbana-Champaign
Responsible party
Kenneth Wilund (Associate Professor, University of Illinois at Urbana-Champaign) — Principal investigator
First posted
Apr 28, 2016
Start date
Feb 2016
Primary completion
Dec 2016
Completion
Feb 2017
Last update
Mar 7, 2017

Study contacts

Kenneth Wilund, PhD
principal investigator · University of Illinois at Urbana-Champaign

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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