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Completed

NCT Number: NCT02753868

Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

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.

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exercise

Behavioral

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 treatment

Procedure

Participants will receive a standard hemodialysis treatment during the study period

Primary outcomes

  1. 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

  2. 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.

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)

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

    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.

  2. Hypotensive event assessment measured by a symptom questionnaire

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

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

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Acronym: ACE-HD

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Apr 28, 2016
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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