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Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02753868
Acronym
ACE-HD
Enrollment
12
Registered
2016-04-28
Start date
2016-02-29
Completion date
2017-02-28
Last updated
2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

Keywords

Intradialytic exercise, Cardiac and arterial function

Brief 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.

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.

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

Participants will receive a standard hemodialysis treatment during the study period

Sponsors

University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatmentEvery 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 techniqueContinous throughout a dialysis treatment (approximately 4 hours)Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.

Secondary

MeasureTime frameDescription
Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a weekA 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.
Hypotensive event assessment measured by a symptom questionnaireThroughout and up to 5 hours after completion of a dialysis treatmentThe presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026