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Trial registered on ANZCTR


Registration number
ACTRN12618001870246
Ethics application status
Approved
Date submitted
4/10/2018
Date registered
16/11/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results provided
16/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of exercise training on muscle function in dialysis patients
Scientific title
Assessment of the impact of different types of training on muscle regenerative activity, on the speed-strength parameters, and the quality of life in hemodialysis (HD) patients
Secondary ID [1] 296153 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end stage renal diseases 309825 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308618 308618 0 0
Physiotherapy
Renal and Urogenital 308619 308619 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To participate in the study, patients were qualified by a nephrologist and a cardiologist. The nephrologist’s permission to participate in the study was based on the patient’s recent health status and biochemistry results. Each patient was informed of the voluntary nature of the study and of the option to withdraw from the exercise training.

To carry out the study, approval from the Bioethics Committee of the University of Physical Education in Wroclaw was obtained. All patients gave their informed written consent to participate in the study.

The research was conducted at the dialysis center of the Department of Nephrology and Transplantation Medicine at the Medical University in Wroclaw (group I and group II) and in a gymnasium in the Department of Physiotherapy of the University of Physical Education in Wroclaw (group III).

Research procedures
Respondents will be divided into 3 groups. Studies with each of the 3 groups will be conducted over a period of 6 months, 3 times a week for 60 minutes (group I and group II) and 2 times a week for 60 minutes (group III). In group I and group II all intervention activities were undertaken whilst undergoing dialysis. In group III on the non-dialysis days.
Group I- patients with ESRD undergoing supervised endurance training during hemodialysis on the MOTOmed letto unit.
Group II- patients with ESRD undergoing supervised resistance training during hemodialysis.
Group III - patients with ESRD participating in training Tai Chi on the non-dialysis days.

Physical Exercise Training
Trainings in group I and group II took place in the first 2 hours of hemodialysis on the seat the patient used for dialysis. Trainings were constantly supervised by a nephrologist and a physiotherapist.
Each training was divided into three parts:
1) Introductory part, a short warm-up lasting 5 minutes. It included active exercises of the lower limbs in recumbent position (simple exercises: flexion, extension in ankles and knee joint without load)
2) Main part, 10-50 min. In this part, depending on the training allocated:
Group I performed endurance training on a MOTOmed letto2cycle ergometer (RECK, Germany) which is a motorized exercise therapy device that has a CE 0124, EMV, ISO Qualitätsmanagement safety certificate which enables a patient to ride in a recumbent or reclined position.
Training on ergometer concentrates on lower limbs, the position was chosen by the patient according to their comfort and, just as important, to the fluency of dialysis. Training intensity was selected on the basis of subjective feelings of the patient and steadily increased from low to moderate levels based on a 10-point fatigue assessment (Borg scale). This is a reliable indicator for evaluating the intensity of physical exercise, among dialysis patients. In the first week of training the length of the cycle ergometer ride was 10 minutes. The objective was to reach exercise intensity level 3 according to the RPE scale. The time was steadily increased while maintaining a moderate level of intensity for a minimum of 2 to 3 weeks. The final stage of rehabilitation was the accomplishment of a 35–50-minute ride on the cycle ergometer at a moderate level of intensity.
The exercise was carried out until reaching subjective feeling of fatigue (5-6 on the 10 –point Borg scale). The number of evolutions and load were constant, individually tailored to the patient depending on the tolerance of a given exercise.
They were as follows: speed regulation from 10 to 60 [RPM], regulation of motor power from 1 to 10 [Nm], and preset therapy duration from 0 to 120 minutes. The parameters were selected in such way that the number of revolutions and the workload made it an endurance type of training. It should be added that the course of training shown on the ergometer screen in the form of a power level achieved [W] for both lower limbs was a motivating factor for the patient to continue with the exercise.
Group II performed resistance training with weights, balls and Thera Bands. Mostly the lower limbs and one upper limb free of the arteriovenous fistula were engaged.
Exercises of the lower limbs included: straightening / bending of the knee, straightening / bending at the hip, adduction / abduction at the hip. Exercises of the upper limbs included: "rowing" single-handedly (limb adduction to the body in the sagittal plane); "squeezing" with one hand (bending limbs in the shoulder joint in the transverse plane, limb in 90° abduction in the coronal plane), bending the forearm at the elbow joint; straightening the forearm in the elbow joint).
One exercise in each exercise referral scheme was performed, the workout consisted of 4 - 5 sets; 1 lightweight 20 repetitions, 2-5 main of 10 - 20 reps; until exhaustion.
The intensity was determined according to subjective feelings, matching color-coded bands or weights adequately. The intensity was increased by raising the number of sets or repetitions while maintaining the load. In the case when a patient reported tolerance, training load was increased and maintained at a constant level for at least 3 trainings (1 week) in order to adapt to a new load.
If the patient showed some progress, the load was increased also in the following week.
Only in the case of indisposition was the load reduced, however, at the next training the previous load was restored.
Exercise was performed until onset of subjective feelings of exhaustion (at the beginning 5-6 in the 10-point Borg scale), however, not until “muscle failure” (in order to avoid the risk of injuries in and around tendons, muscle attachments, etc.).
Weights used for the lower limbs were: 1.1 kg – 3.7 kg; for upper limbs: 1-3 kg. The duration of the main part was increased gradually from 10 minutes in the initial period of training up to 50 minutes. Resistance training was completed in a seated position.

3) Final part, relaxation, lasted about 5min. and included free active exercises of the lower limbs in recumbent position as well as breathing exercises. Stopping exercises during the training session was allowed in cases where a participant was feeling unwell or fatigued, experienced the onset of muscular, joint or coronary pain, nausea, dizziness or shortness of breath, obtained a heart rate above 80% of maximum (HRmax), exceeded blood pressure values above 200/110 mmHg or below 110/50 mmHg, and in the case of incapacity to maintain the recommended exercise pace. For safety reasons, heart rate, blood pressure and the degree of subjective fatigue levels according to the 10-point Borg scale were monitored before, during and after exercise.

Group III had Tai Chi training under constant supervision of a certified Tai Chi specialist and an attending practitioner. The Tai Chi 24-form Yang (24 forms of Beijing) was used in the training. The form 24 Tai Chi Chuan of the Yang style was the most common form of Tai Chi training, defined as a standardised form from Beijing.
The intensity of classes increased gradually. For patients’ safety, a team of therapists were monitoring the limits permissible in cardiac rehabilitation concerning heart rate and blood pressure, as defined by international standards. In addition, the basic parameter determining the maximum safe level of physical activity was the heart rate limit (HRmax), which was determined individually for each patient during the exercise stress test. An increase in the heart rate of up to 50% HRmax of in weeks 1–4, up to 60% of the rate in weeks 4–8, up to 70% in weeks 8–16, and up to 80% in weeks 16–24 was deemed safe. An allowable subjective submaximal fatigue during training, not exceeding 7-8 points on a simplified 10-point Borg scale, was also considered.
Physical therapist was administering the intervention.
Intervention code [1] 312517 0
Rehabilitation
Comparator / control treatment
The study consisted in comparing three active groups. Group I had supervised endurance training during hemodialysis, group II had supervised resistance training during hemodialysis and group III participated in Tai Chi training on the non-dialysis days.
Control group
Active

Outcomes
Primary outcome [1] 307630 0
Assessment of lower limb strength - force-velocity parameters of flexor and extensor muscles in the knee joints was tested with the Biodex Multi-Joint 4 Isokinetic Dynamometer
Timepoint [1] 307630 0
Baseline and after 6 months
Primary outcome [2] 307631 0
Assessment of exercise tolerance – ergospirometry stress test on a cycle ergometer (VO2max) was performed using a k4b2 cardiopulmonary ergospirometer by COSMED
Timepoint [2] 307631 0
Baseline and after 6 months
Primary outcome [3] 307632 0
Assessment of self reported quality of life - KDQOL-SF TM (Kidney Disease Quality of Life - Short Form TM)
Timepoint [3] 307632 0
Baseline and after 6 months
Secondary outcome [1] 352457 0
Assessment of functional fitness - Rikli & Jones Test
Timepoint [1] 352457 0
Baseline and after 6 months
Secondary outcome [2] 352458 0
Assessment of physical function - 6-Minute Walk Test (6 MWT)
Timepoint [2] 352458 0
Baseline and after 6 months
Secondary outcome [3] 352537 0
Assessment of physical activity - International Physical Activity Questionnaire (IPAQ)
Timepoint [3] 352537 0
Baseline and after 6 months.
Secondary outcome [4] 352538 0
Assessment of lower extremity muscle mass - magnetic resonance imaging (MRI) of the quadriceps muscle.
Timepoint [4] 352538 0
Baseline and after 6 months.
Secondary outcome [5] 352539 0
Assessment of body composition - electrical bioimpedance (BIA),
Timepoint [5] 352539 0
Baseline and after 6 months.
Secondary outcome [6] 352540 0
Assessment of hand grip strength - dynamometer test
Timepoint [6] 352540 0
Baseline and after 6 months.
Secondary outcome [7] 352541 0
Assessment of the severity of depressive symptoms - Beck Depression Inventory (BDI).
Timepoint [7] 352541 0
Baseline and after 6 months.
Secondary outcome [8] 352542 0
Assessment of the level of anxiety as a state and as a trait - Spielberg's State-Trait Anxiety Inventory (STAI).
Timepoint [8] 352542 0
Baseline and after 6 months.
Secondary outcome [9] 352544 0
Assessment of the nutritional status - The Mini Nutritional Assessment (MNA) Scale.
Timepoint [9] 352544 0
Baseline and after 6 months.
Secondary outcome [10] 352545 0
Assessment of the bone density - DEXA
Timepoint [10] 352545 0
Baseline and after 6 months.
Secondary outcome [11] 353792 0
Assessment of electrolytes (Na+) in the blood
Timepoint [11] 353792 0
Baseline and after 6 months
Secondary outcome [12] 353795 0
Assessment the level of urea in the blood
Timepoint [12] 353795 0
Baseline and after 6 months
Secondary outcome [13] 353796 0
Assessment of calcium in the blood
Timepoint [13] 353796 0
Baseline and after 6 months
Secondary outcome [14] 353797 0
Assessment of C-reactive protein (CRP) in the blood
Timepoint [14] 353797 0
Baseline and after 6 months
Secondary outcome [15] 353798 0
Assessment of Kt/V test in the blood
Timepoint [15] 353798 0
Baseline and after 6 months
Secondary outcome [16] 353799 0
Assessment of cytokines IL-6 in the blood
Timepoint [16] 353799 0
Baseline and after 6 months
Secondary outcome [17] 353800 0
Assessment of TNF-alpha in the blood
Timepoint [17] 353800 0
Baseline and after 6 months
Secondary outcome [18] 353801 0
Assessment of growth factors [insulin-like growth factor (IGF-1) in the blood
Timepoint [18] 353801 0
Baseline and after 6 months
Secondary outcome [19] 353835 0
Assessment the level of creatinine in the blood
Timepoint [19] 353835 0
Baseline and after 6 months
Secondary outcome [20] 353941 0
Assessment of electrolytes (K+) in the blood
Timepoint [20] 353941 0
Baseline and after 6 months
Secondary outcome [21] 353942 0
Assessment of albumin in the blood
Timepoint [21] 353942 0
Baseline and after 6 months
Secondary outcome [22] 353943 0
Assessment of total protein in the blood
Timepoint [22] 353943 0
Baseline and after 6 months
Secondary outcome [23] 353944 0
Assessment of hepcidin in the blood
Timepoint [23] 353944 0
Baseline and after 6 months
Secondary outcome [24] 353945 0
Assessment of cytokines IL-8 in the blood
Timepoint [24] 353945 0
Baseline and after 6 months
Secondary outcome [25] 353946 0
Assessment of platelet-derived growth factor (muscular isoform, PDGF-BB) in the blood
Timepoint [25] 353946 0
Baseline and after 6 months
Secondary outcome [26] 353947 0
Assessment of IGF-binding protein-3 (IGFBP-3) in the blood
Timepoint [26] 353947 0
Baseline and after 6 months

Eligibility
Key inclusion criteria
• suffering from End-Stage Renal Diseases (ESRD)
• haemodialysis treatment for at least 3 months prior to the initiation of research
• adequate dialysis therapy: dialysis adequacy ratio Kt/V >1,2; the ratio of protein catabolism - PCR 0,8-1,4 g protein/kg of body weight /day
• qualified to the project by a nephrologist and cardiologist
• giving informed written consent.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• contraindications to exercise testing and/or physical training
• changes in the musculoskeletal system hampering the execution of tests and workout
• attended fewer than 50 training sessions (<70% of the training cycle) in groups I and II and attended fewer than 36 training sessions (<70% of the training cycle) in group III
• lack of logical contact with the patient (especially due to dementia).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomization concerned only Group I and Group II, which had training during dialysis. It was employed a cluster randomised uncontrolled trial methodology. A cluster (group/place) in the study was formed by group of subjects attending to dialysis sessions regularly performed in the same room (one of two available room) at one of six available dialysis shifts. We followed the rule that one type of training was provided for one cluster (patients in one room for dialysis shift). Group III (25 people) was chosen randomly, but from this group only 4 people declared their participation in Tai Chi training in non dialysis days. Therefore, a group III finally consisted of people who wanted to take part in training on days off. The organization of this group took me more than half a year.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2013
Date of last participant enrolment
Anticipated
Actual
22/06/2015
Date of last data collection
Anticipated
Actual
28/12/2015
Sample size
Target
75
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 20892 0
Poland
State/province [1] 20892 0

Funding & Sponsors
Funding source category [1] 300744 0
Government body
Name [1] 300744 0
National Science Centre
Country [1] 300744 0
Poland
Primary sponsor type
Individual
Name
Wioletta Dziubek-Rogowska
Address
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country
Poland
Secondary sponsor category [1] 300278 0
None
Name [1] 300278 0
Address [1] 300278 0
Country [1] 300278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301523 0
Senacka Komisja ds. Etyki Badan Naukowych przy Akademii Wychowania Fizycznego we Wroclawiu
Ethics committee address [1] 301523 0
Ethics committee country [1] 301523 0
Poland
Date submitted for ethics approval [1] 301523 0
05/12/2011
Approval date [1] 301523 0
18/01/2012
Ethics approval number [1] 301523 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87278 0
Dr Wioletta Dziubek-Rogowska
Address 87278 0
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country 87278 0
Poland
Phone 87278 0
+48504032148
Fax 87278 0
Email 87278 0
wioletta.dziubek@awf.wroc.pl
Contact person for public queries
Name 87279 0
Wioletta Dziubek-Rogowska
Address 87279 0
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country 87279 0
Poland
Phone 87279 0
+48504032148
Fax 87279 0
Email 87279 0
wioletta.dziubek@awf.wroc.pl
Contact person for scientific queries
Name 87280 0
Wioletta Dziubek-Rogowska
Address 87280 0
University School of Physical Education
al. Ignacego Jana Paderewskiego 35
51-612 Wroclaw
Country 87280 0
Poland
Phone 87280 0
+48504032148
Fax 87280 0
Email 87280 0
wioletta.dziubek@awf.wroc.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately after the publication of the material in the journal. End-date of availability: 6 months from publication.
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
requirement to sign data access agreement


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
64Ethical approval    376055-(Uploaded-31-10-2018-21-30-55)-Study-related document.pdf



Results publications and other study-related documents

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