Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

Kidney Failure Clinical Trial

— ACE-HD  

Official title:

Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753868
• Other study ID #: 15691
• Status: Completed
• Phase: N/A
• First received: February 27, 2016
• Last updated: March 5, 2017
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Behavioral:
• exercise
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

Procedure:
• Hemodialysis treatment
Participants will receive a standard hemodialysis treatment during the study period

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
Primary	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.	Continous throughout a dialysis treatment (approximately 4 hours)
Secondary	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.	Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
Secondary	Hypotensive event assessment measured by a symptom questionnaire	The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.	Throughout and up to 5 hours after completion of a dialysis treatment