Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients (ACE-HD)
Primary Purpose
Kidney Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise
Hemodialysis treatment
Sponsored by
About this trial
This is an interventional supportive care trial for Kidney Failure focused on measuring Intradialytic exercise, Cardiac and arterial function
Eligibility Criteria
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.
Sites / Locations
- University of Illinois at Urbana-Champaign
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Standard Hemodialysis
Hemodialysis with Exercise (1-st hr)
Hemodialysis with Exercise (3-rd hr)
Arm Description
Participants will be monitored during their normal hemodialysis treatment with no intervention administered
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
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
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
Hypotensive event assessment measured by a symptom questionnaire
The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.
Full Information
NCT ID
NCT02753868
First Posted
February 27, 2016
Last Updated
March 5, 2017
Sponsor
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT02753868
Brief Title
Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients
Acronym
ACE-HD
Official Title
Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
Intradialytic exercise, Cardiac and arterial function
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Hemodialysis
Arm Type
Experimental
Arm Description
Participants will be monitored during their normal hemodialysis treatment with no intervention administered
Arm Title
Hemodialysis with Exercise (1-st hr)
Arm Type
Experimental
Arm Description
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
Arm Title
Hemodialysis with Exercise (3-rd hr)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis treatment
Intervention Description
Participants will receive a standard hemodialysis treatment during the study period
Primary Outcome Measure Information:
Title
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
Description
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)
Title
Changes in cardiac output (mL/min) measured by thoracic impedance technique
Description
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 Outcome Measure Information:
Title
Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
Description
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
Title
Hypotensive event assessment measured by a symptom questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Wilund, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35018639
Citation
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.
Results Reference
derived
Learn more about this trial
Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients
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