search
Back to results

Aerobic Exercise During Hemodialysis

Primary Purpose

Kidney Failure, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic exercise with cycle ergometer during hemodialysis
Sponsored by
Universidade Católica de Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring HEMODIALYSIS, Kidney Failure, Chronic, AEROBIC EXERCISE

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The participants of the study were chronic kidney disease patients on hemodialysis for more than 3 months, with a thrice-weekly, for 4 hours and using arteriovenous fistula. The inclusion criteria were residual diuresis less than 500 mL/day; hemodynamic stability during HD treatment (hypotension episodes in <15% of the sessions); good vascular access allowing a blood flow rate greater than 250 mL/min; a hemoglobin level greater than 9.0 g/dL, able to keep sitting and standing balance and walk without assistance, and to be already participating in the exercise program during dialysis.

Exclusion Criteria:

Exclusion criteria were the use of catheter as venous access, symptomatic ischemic heart disease, myocardial infarction less than 6 months, uncontrolled hypertension, pleural or pericardial friction rub, aortic stenosis.

Sites / Locations

  • Hospital São Francisco de Paula

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hemodialysis session with exercise

hemodialysis session without exercise

Arm Description

Patients were included in a randomly crossover study design such that each patient received one HD session with exercise (intervention) and the next session without exercise (control), alternating for six consecutive HD sessions.

Each patient received one hemodialysis session without exercise

Outcomes

Primary Outcome Measures

The main outcome was the dialysate concentrations of urea, creatinine, potassium and phosphate.
The dialysate is collected by continuous spent sampling of dialysate (CSSD). For the CSSD technique, spent dialysate was continuously sampled by a reversed automatic infusion pump (Lifemed®) at a rate of 10 mL/hour. The dialysate concentrations of urea, creatinine, potassium and phosphate are measured in the sample recipient and the total masses removed are calculated by multiplying the dialysate concentration by the estimated total dialysate volume.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2013
Last Updated
September 4, 2013
Sponsor
Universidade Católica de Pelotas
search

1. Study Identification

Unique Protocol Identification Number
NCT01912417
Brief Title
Aerobic Exercise During Hemodialysis
Official Title
Aerobic Exercise Increases Phosphate Removal During Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Católica de Pelotas

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of aerobic exercise during dialysis on the hemodialysis efficacy in the removal of small molecules measured by continues spend sampling of dialysate (liquid metabolites produced by the body which is disposed) technique.
Detailed Description
This is a controlled clinical trial with participants recruited from the dialysis unit of a university hospital (a tertiary-care centre). All patients from this unit who agreed and that had no medical contraindications had already been included in a resistance and aerobic intradialytic training program. In this unit, the size of the low flux polysulfone dialyzers is selected according to patient's body surface area and the dialyzers are reused up to twelve times. The target Kt/V is 1.2 or higher. The target hemoglobin level is from 10.5 to 12.5 g/dL. Dialysis is performed using On-Line Clearance Monitor (OCM)-equipped Fresenius 4008-S machines (Fresenius, Bad Homburg, Germany). Design: Patients are included in a randomly crossover study design such that each patient receives one HD session with exercise (intervention) and the next session without exercise (control), alternating for six consecutive HD sessions. The blood flow is maintained at around 300mL/minute and the dialysate flow at 500mL/minute. The dialysate calcium concentration used is 3.0 mEq/L. A new dialyzer is used in the first HD session of each patient at the study, and the dialyzer is reprocessed and reused up to 12 times according to its priming in subsequent sessions. During every HD session continuous spent sampling of dialysate is obtained. The study began in August 2010. Interventions - Participants underwent hemodialysis sitting in a reclining chair. They trained on an Equimond© mechanically braked cycle ergometer, which we positioned and stabilized in front of the participants while they sit in their chairs during hemodialysis. The training is performed in the first 2 hours of hemodialysis, with a total exercise time of 60 minutes. Each exercise period of 20 minutes is separated by 10 minutes of rest. The patients are advised to work with a level of perceived exertion of 'somewhat strong' (13-14 of Borg scale). For safety, heart rate and blood pressure is monitored throughout the session. The training is terminated if the patients exceeded 80% of their maximum heart rate (MHR = 220 - age in years), blood pressure parameters are exceeded (above 200/110 or below 110/50mmHg) or the patient had chest pain, severe dyspnea, wheezing, leg cramps, confusion, visual symptoms, pallor or cyanosis. Training is conducted by physiotherapists. Data Collection - Age, gender, skin color, time since starting dialysis therapy and co-morbidity are recorded at baseline. Each patient's hemoglobin level, hematocrit, blood pressure, body mass index (kg/m2) are noted at the beginning and end of the study period. Serum concentration of urea, creatinine, potassium and phosphate are obtained before, after, and 30 minutes after each HD session. The dialysate concentration of urea, creatinine, potassium and phosphate and Kt/V estimated by OCM were obtained during each HD session. The laboratory analyses are conducted by a technician blinded to allocation groups. The OCM measures the difference in conductivity between the dialysate that is coming in and out of the dialyzer and gives an estimated value of Kt/V.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
HEMODIALYSIS, Kidney Failure, Chronic, AEROBIC EXERCISE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemodialysis session with exercise
Arm Type
Experimental
Arm Description
Patients were included in a randomly crossover study design such that each patient received one HD session with exercise (intervention) and the next session without exercise (control), alternating for six consecutive HD sessions.
Arm Title
hemodialysis session without exercise
Arm Type
No Intervention
Arm Description
Each patient received one hemodialysis session without exercise
Intervention Type
Other
Intervention Name(s)
Aerobic exercise with cycle ergometer during hemodialysis
Intervention Description
Participants underwent hemodialysis trained on an cycle ergometer. The training is performed in the first 2 hours of hemodialysis, with a total exercise time of 60 minutes. Each exercise period of 20 minutes was separated by 10 minutes of rest. The patients are advised to work with a level of perceived exertion of 'somewhat strong' (13-14 of Borg scale). For safety, heart rate and blood pressure were monitored throughout the session. The training is terminated if the patients exceeded 80% of their maximum heart rate (MHR = 220 - age in years), blood pressure parameters are exceeded (above 200/110 or below 110/50mmHg) or the patient had chest pain, severe dyspnea, wheezing, leg cramps, confusion, visual symptoms, pallor or cyanosis.
Primary Outcome Measure Information:
Title
The main outcome was the dialysate concentrations of urea, creatinine, potassium and phosphate.
Description
The dialysate is collected by continuous spent sampling of dialysate (CSSD). For the CSSD technique, spent dialysate was continuously sampled by a reversed automatic infusion pump (Lifemed®) at a rate of 10 mL/hour. The dialysate concentrations of urea, creatinine, potassium and phosphate are measured in the sample recipient and the total masses removed are calculated by multiplying the dialysate concentration by the estimated total dialysate volume.
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participants of the study were chronic kidney disease patients on hemodialysis for more than 3 months, with a thrice-weekly, for 4 hours and using arteriovenous fistula. The inclusion criteria were residual diuresis less than 500 mL/day; hemodynamic stability during HD treatment (hypotension episodes in <15% of the sessions); good vascular access allowing a blood flow rate greater than 250 mL/min; a hemoglobin level greater than 9.0 g/dL, able to keep sitting and standing balance and walk without assistance, and to be already participating in the exercise program during dialysis. Exclusion Criteria: Exclusion criteria were the use of catheter as venous access, symptomatic ischemic heart disease, myocardial infarction less than 6 months, uncontrolled hypertension, pleural or pericardial friction rub, aortic stenosis.
Facility Information:
Facility Name
Hospital São Francisco de Paula
City
Pelotas
State/Province
Rio Grande do Sul
ZIP/Postal Code
96020-220
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Aerobic Exercise During Hemodialysis

We'll reach out to this number within 24 hrs