Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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11 June 2018 |
Main ID: |
ACTRN12618000724279 |
Date of registration:
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02/05/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of the effectiveness of home-based physical training in patients undergoing haemodialysis
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Scientific title:
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The effects of home-based physical training in patients undergoing haemodialysis on physical functioning, body composition, quality of life, fatigue and selected properties of blood |
Date of first enrolment:
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10/08/2015 |
Target sample size:
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50 |
Recruitment status: |
Completed |
URL:
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http://www.anzctr.org.au/ACTRN12618000724279.aspx |
Study type:
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Interventional |
Study design:
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Randomised controlled trial
Parallel |
Phase:
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Not Applicable
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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end stage renal diseases
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Intervention(s)
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Before starting the project, individual face to face meetings (the patient vs nephrologist and the patient vs physiotherapist) were conducted, during which patients received a leaflet with basic information about the project (title, aim, qualification process, description of the intervention). Patients had the opportunity to ask questions about participation in the project.
Every patient received the necessary equipment: stationary ergometer and a Polar Sports-tester, as well as written instruction including: proper preparation to exercises, description of the parameters monitored during training and activity after completion of the training.
Patients randomly qualified for the training group participated in 6-month home-based physical training with recommended frequency 3 times a week on days without dialysis treatment. Every training session lasts 30 minutes (3 times 10-minute interval) at the individual level of heart rate reserve (HRR) determined on the basis of electrocardiographic exercise testing and/or on a subjective level of fatigue using Borg scale (Rate of Perceived Exertion scale).
Two physiotherapists were specially recruited to train and monitor the training session of patients.
At the beginning individual (face to face) training sessions for the patients supervised by physiotherapist were done at the haemodialysis center. Then home-based physical training starts in the participants’ home. Each physical training session is preceded and ended by blood pressure measurement and telephone contact with the physiotherapist. Every 4 weeks and when it was necessary, meeting with physiotherapists to record training data took placed in haemodialysis centre.
Intervention (training program) period: 6 months (2 periods; 3 months each)
The recommendation of the training dose:
Frequency: 3 times per week on non-dialysis days
Duration of the training: 5 min. warm-up exercises (plantar flexion/dorsiflexion, standing calf raise, knee and hip flexion, hip abduction and adduction followed by 10 repetitions of stepping and squats, then 2 min. of cycling with no resistance); 30-35 min. main training activity - interval training aerobic exercises on stationary ergometer (3 x 10 min. work phases alternated with 2 x 2-3 min. resting periods) and 5 min. cool down exercises (range-of-motion exercises, breathing and relaxing exercises).
Exercise intensity: at the individual level of 40-60% heart rate reserve (HRR) determined on the basis of electrocardiographic exercise testing and/or on a subjective level of fatigue using Borg scale (Rate of Perceived Exertion scale) <=3 on 0-10 scale.
The dose of training was individually adopted to physical fitness of participants. The heart rate reserve was assessed at baseline and after 3 month of intervention. The rate of perceived exertion was assessed during every training session.
Patients used Polar Sports-tester, which confirmed participation in the training and included the following criteria: training time, frequency, intensity. Threshold of heart rate was entered into the Polar Sports-tester so that the patient was able to monitor the course of the main phase on the recommended safe level of intensity (40-60% HRR). Each rehabilitation session finished with the re-measurement of blood pressure, and then the patient called the physiotherapist to inform the initial and final blood pressure values and (Rate of Perceived Exertion scale) fatigue levels evaluated in the Borg scale.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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