Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000724279
Ethics application status
Approved
Date submitted
27/03/2018
Date registered
2/05/2018
Date last updated
2/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of home-based physical training in patients undergoing haemodialysis
Scientific title
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
Secondary ID [1] 294721 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end stage renal diseases 306383 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305471 305471 0 0
Physiotherapy
Renal and Urogenital 305472 305472 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300231 0
Rehabilitation
Comparator / control treatment
There wasn’t intervention in non-training control group during 6 moths. After this period patients of the non-training control group were allowed to participate in the training group.
Control group
Active

Outcomes
Primary outcome [1] 304692 0
Assessment of exercise tolerance – 12-lead electrocardiographic exercise testing on cycle ergometer (ASPEL CRG 200) cooperating with the CardioTEST BETA SYSTEM v.001. Exercise resistance is measured in Watts (W). An initial exercise is at 25 W then resistance is increased by 25 W every 2 minutes. The patient should reach the submaximal capacity 85% of the age-predicted maximum HR.
Timepoint [1] 304692 0
Baseline, 3 month and 6 month (primary endpoint) after intervention commencement
Primary outcome [2] 304817 0
Assessment of functional fitness - Fullerton Test
Timepoint [2] 304817 0
Baseline, 3 month and 6 month (primary endpoint) after intervention commencement
Secondary outcome [1] 343284 0
Assessment of self reported quality of life - KDQOL-SF TM (Kidney Disease Quality of Life - Short Form TM)
Timepoint [1] 343284 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [2] 343285 0
Assessment of physical function - 6 MWD Test (6 Minute Walking Distance)
Timepoint [2] 343285 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [3] 343286 0
Assessment of peripheral blood pressure - blood pressure monitor
Timepoint [3] 343286 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [4] 343287 0
Assessment of physical activity - International Physical Activity Questionnaire (IPAQ)
Timepoint [4] 343287 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [5] 343288 0
Assessment of body mass composition - Bioelectrical Impedance Analysis (BIA)
Timepoint [5] 343288 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [6] 343289 0
Assessment of independence in activities of daily living - Katz index
Timepoint [6] 343289 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [7] 343290 0
Assessment of independence of instrumental activities of daily living - Lawton Index
Timepoint [7] 343290 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [8] 343291 0
Assessment of hand grip strength - dynamometer test
Timepoint [8] 343291 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [9] 343292 0
Assessment of lower extremities strength - Sit to Stand to Sit Test (STSTS Test)
Timepoint [9] 343292 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [10] 343293 0
Assessment of self-reported fatigue - FACIT Fatigue Scale (version 4)
Timepoint [10] 343293 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [11] 343295 0
Change in rheological properties of blood composite of AI- aggregation of RBC (red blood cells) index; EI- elongation of RBC index (red blood cells deformability) using Analizator Laser- assisted Optical Rotational Cell Analyser (LORCA) RR Mechatronics.
Blood sample was used in testing.
Timepoint [11] 343295 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [12] 346074 0
Change in biochemical profile composite of tNO3 (Cayman’s Nitrate/Nitrite Colorimetric Assey Kit), Fibrinogen (Koagulometr Chrom 7, Bio-Ksel) and Irisin - Human Irisin Elisa Kit.
Blood sample (serum) was used in testing.
Timepoint [12] 346074 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [13] 346077 0
Assessment of hematological parameters of the blood: Hemoglobin, g/dL; Hematocrit, %; Erythrocytes (x1012/L); Leukocyte count (x109/L); Platelet count (x109/L).
Timepoint [13] 346077 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [14] 346078 0
Assessment of heart structure and function using echocardiograph ALOKA ProSound SSD-4000 SV; Transducer UST-5299- Phyased Array (1,0 - 5 MHz).
Composite outcome consisting of parameters:
Mitral valve medium and maximum pressure gradient, mm Hg
E/A ratio
RVSP – right ventricular systolic pressure, mmHg
Left ventricular end-diastolic and end-systolic diameter, mm
Intra-ventricular septal thickness (IVS) during systole and diasystole, mm
Left ventricular posterior wall (PW) during systole and diasystole, mm
Left atrial size, mm
Right ventricular size, mm
Timepoint [14] 346078 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [15] 346092 0
Assessment of levels of minerals in the blood composite of Calcium, mg/dL and Phosphorous, mg/dL .
Timepoint [15] 346092 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [16] 346093 0
Assessment of electrolyte balance composite of Potassium, mmol/L and Sodium, mmol/L in the blood.
Timepoint [16] 346093 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [17] 346095 0
Assessment of nutritional status - serum blood level of proteins Albumin, g/dL
Timepoint [17] 346095 0
Baseline, 3 month and 6 month after intervention commencement
Secondary outcome [18] 346096 0
Assessment of renal function composite of Urea, mg/dL and Creatinine, mg/dL. Blood sample was used in testing.
Timepoint [18] 346096 0
Baseline, 3 month and 6 month after intervention commencement

Eligibility
Key inclusion criteria
- suffering from End-Stage Renal Diseases and
- treated by haemodialysis at least 3 month and
- qualified to the project by a nephrologist and cardiologist and
- health condition enabling participation in the project (no contraindications to physical training)
- giving informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lack of logical contact with the patient

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by the sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The urn randomization (design) was done for assigning patients to groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
During the first 6 months the training group participated in home-based physical training program while the non-training control group did not have any intervention.
After 6 months of observation, participants of the non-training control group were allowed to participate in the training group but the participants of the training group were not allowed to participate in non- training control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis of the collected results with: mean values, standard deviation, range, quartile and modal. The Shapiro-Wilk test for normality. Comparison of test results by ANOVA variance analysis - model with repeated measurements. Use of non parametric Mann-Whitney assays. Correlation analysis for selected values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
19/09/2016
Date of last data collection
Anticipated
Actual
9/05/2017
Sample size
Target
50
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 9633 0
Poland
State/province [1] 9633 0
Malopolska

Funding & Sponsors
Funding source category [1] 298532 0
Charities/Societies/Foundations
Name [1] 298532 0
Amicus Renis Foundation
Country [1] 298532 0
Poland
Funding source category [2] 298814 0
University
Name [2] 298814 0
University of Physical Education in Cracow
Country [2] 298814 0
Poland
Primary sponsor type
Individual
Name
Katarzyna Chojak-Fijalka
Address
University of Physical Education in Cracow
Physiotherapy Department
al. Jana Pawla II 78
31-571 Kraków
Country
Poland
Secondary sponsor category [1] 297679 0
None
Name [1] 297679 0
Address [1] 297679 0
Country [1] 297679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299507 0
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Krakowie
Ethics committee address [1] 299507 0
ul. Krupnicza 11a
31-123 Kraków
Ethics committee country [1] 299507 0
Poland
Date submitted for ethics approval [1] 299507 0
27/11/2014
Approval date [1] 299507 0
12/12/2014
Ethics approval number [1] 299507 0
107/KBL/OIL/2014

Summary
Brief summary
Chronic haemodialysis therapy is a burdensome and time-consuming treatment. Finding time for regular physical activity is difficult. Since the early 1970's, many studies have been published on the effects of physical training in haemodialysed patients. Most of them described the intradialytic exercise training but only a few of them described the use of home-based training. This form of training allows the patient to adapt it to their individual lifestyle. Patients can work out in a familiar environment with the support of their family members. The previous programs included very small groups, usually without a control group. Therefore, an aim of this study was to implement program using home-based physical training in a larger group of haemodialysed patients. Controlled and random research was planned.
The primary purpose of the study is evaluation of the effectiveness of home-based physical training program in patients undergoing haemodialysis.
The authors hypothesize that physical training will have impact on effort tolerance, physical fitness, muscle strength and endurance, independence in activities of daily living, haemodynamic parameters, heart structure and function, composition of body mass, haematological, rheological and biochemical parameters of blood, quality of life, and self-reported fatigue.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80650 0
Mrs Katarzyna Chojak-Fijalka
Address 80650 0
University of Physical Education in Cracow
Physiotherapy Department
Department of Physical Medicine and Wellness
al. Jana Pawla II 78
31-571 Kraków
Country 80650 0
Poland
Phone 80650 0
+48 683 11 24
Fax 80650 0
Email 80650 0
katarzyna.chojak@awf.krakow.pl
Contact person for public queries
Name 80651 0
Mrs Katarzyna Chojak-Fijalka
Address 80651 0
University of Physical Education in Cracow
Physiotherapy Department
Department of Physical Medicine and Wellness
al. Jana Pawla II 78
31-571 Kraków
Country 80651 0
Poland
Phone 80651 0
+48 683 11 24
Fax 80651 0
Email 80651 0
katarzyna.chojak@awf.krakow.pl
Contact person for scientific queries
Name 80652 0
Mrs Katarzyna Chojak-Fijalka
Address 80652 0
University of Physical Education in Cracow
Physiotherapy Department
Department of Physical Medicine and Wellness
al. Jana Pawla II 78
31-571 Kraków
Country 80652 0
Poland
Phone 80652 0
+48 683 11 24
Fax 80652 0
Email 80652 0
katarzyna.chojak@awf.krakow.pl

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