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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

end stage renal diseases

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Renal and Urogenital

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]

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]

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]

Baseline, 3 month and 6 month (primary endpoint) after intervention commencement

Primary outcome [2]

Assessment of functional fitness - Fullerton Test

Timepoint [2]

Baseline, 3 month and 6 month (primary endpoint) after intervention commencement

Secondary outcome [1]

Assessment of self reported quality of life - KDQOL-SF TM (Kidney Disease Quality of Life - Short Form TM)

Timepoint [1]