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Trial registered on ANZCTR


Registration number
ACTRN12617000420347
Ethics application status
Approved
Date submitted
17/03/2017
Date registered
23/03/2017
Date last updated
23/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of practicing yoga during haemodialysis for fatigue in patients with end stage kidney disease.
Scientific title
Evaluating the effectiveness of intradialytic yoga for fatigue in patients with end stage kidney disease receiving haemodialysis: A mixed methods approach.
Secondary ID [1] 291438 0
Nil known
Universal Trial Number (UTN)
U1111-1194-3161
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage kidney disease requiring haemodialysis treatment 302462 0
Condition category
Condition code
Renal and Urogenital 302024 302024 0 0
Kidney disease
Alternative and Complementary Medicine 302096 302096 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention will be group yoga sessions conducted during routine haemodialysis (HD) treatment (i.e. intradialytic yoga) 3 times per week at 2 dialysis clinics in Brisbane Queensland. Participants randomised to the intervention group will also continue to maintain their current treatment, health and lifestyle practices.

The intradialytic yoga protocol is based on a therapeutic style of yoga known as 'Viniyoga' and has been designed to enable HD patients of various age groups, health conditions and comorbidities to participate. Group yoga sessions will commence during the first hour of treatment, immediately after the participant has been connected to the dialysis machine, is comfortable and stable. Sessions will involve a series of gentle movements, stretching, breathing exercises, relaxation techniques and meditation while comfortably seated in a dialysis chair. Yoga practices will be tailored to the individual needs of the group. To ensure the safety and comfort of participants and to reduce the risk of injury, the Chief Investigator will offer participants modifications including alternative postures, and physical adjustments when needed. Participants will also be strongly encouraged to practice at their own level based on how well they feel at each session.

The intervention period is 12 weeks. The duration of yoga sessions will progressively increase in length commencing at 15 minutes per session, and will gradually increase by 10 minutes per session every 3 weeks building up to 45 minutes by the end of the study.

The Chief Investigator who is a qualified yoga teacher will facilitate all group yoga sessions in the study. This will maintain fidelity in delivery of the intervention throughout the study ensuring the sequences and primary features of the intervention will be consistently delivered as proposed in the protocol.

Adherence will also continuously be monitored and documented throughout the study. This will be measured as the frequency and duration (in minutes) of participation per session, and qualitative feedback from participants.
Intervention code [1] 297483 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control group will receive usual care alone. This will involve continuing to maintain current treatment, health and lifestyle practices, and agreeing not engage in community yoga classes or programs.
Control group
Active

Outcomes
Primary outcome [1] 301454 0
The primary outcome will be the change in symptoms of fatigue as measured by the Chalder Fatigue Questionnaire (CFQ).
Timepoint [1] 301454 0
Baseline (week 0), mid way (week 6) and at the end of the study (week 12).
Secondary outcome [1] 332716 0
Change in symptoms of post dialysis fatigue recorded by the participant using a Post Dialysis Fatigue Diary developed for the study with reference to the literature.
Timepoint [1] 332716 0
At baseline (week 0), mid way (week 6) and at the end of the study (week 12).
Secondary outcome [2] 332717 0
Change in health related quality of life assessed using the Kidney Disease and Quality of Life Short Form (KDQoL SF).
Timepoint [2] 332717 0
At baseline (week 0) and at the end of the study (week 12).
Secondary outcome [3] 332718 0
Changes in levels of Potassium found in participant blood test results to be extracted from medical records.
Timepoint [3] 332718 0
At baseline (week 0) and at the end of the study (week 12).
Secondary outcome [4] 332719 0
Changes in interdialytic fluid gain measures extracted from participant medical records.
Timepoint [4] 332719 0
At baseline (week 0) and at the end of the study (week 12).
Secondary outcome [5] 332720 0
Changes in the following kidney disease specific biochemical markers found in participant blood test results to be extracted from medical records: Blood count (haemoglobin); C Reactive Protein (inflammation); Urea; Transferrin saturation (iron deficiency); Ferritin; Creatinine; Alkaline Phosphatase; Intact parathyroid hormone; Albumin; Erythrocyte count; Hematocrit; Kt/V (dialysis adequacy); and Electrolytes (Bicarbonate – acid base).
Timepoint [5] 332720 0
At baseline (week 0) and at the end of the study (week 12).
Secondary outcome [6] 332721 0
Monitoring and documentation of safety and adverse events including: vascular access dysfunction; hypotensive/hypertensive episodes; muscle cramps; musculoskeletal injuries; cardiovascular events; hospitalisations; and deaths. The Chief Investigator will also visually observe participants during intradialytic yoga sessions and seek verbal feedback to monitor and document adverse signs and symptoms potentially triggered by the intervention.
Timepoint [6] 332721 0
Continuously throughout the study period - every intradialytic yoga session (i.e. 3 sessions per week over 12-weeks).
Secondary outcome [7] 332722 0
Feasibility and acceptability via documentation of recruitment and dropout rates.
Timepoint [7] 332722 0
Continuously throughout the study period - every intradialytic yoga session (i.e. 3 sessions per week over 12-weeks).
Secondary outcome [8] 332723 0
Participant beliefs and expectations about the intradialytic yoga intervention will be assessed using the Credibility Expectancy Questionnaire (CEQ). The CEQ is a self-administered scale consisting of 6 questions related to thoughts and feelings about the therapy participants will receive.
Timepoint [8] 332723 0
At baseline (week 0) and at the end of the study (week 12).
Secondary outcome [9] 332854 0
Changes in levels of Phosphate found in participant blood test results to be extracted from medical records.
Timepoint [9] 332854 0
At baseline (week 0) and at the end of the study (week 12).
Secondary outcome [10] 332951 0
Adherence to the intervention measured as frequency and duration (in minutes) of participation per session.
Timepoint [10] 332951 0
Continuously throughout the study period - every intradialytic yoga session (i.e. 3 sessions per week over 12-weeks).
Secondary outcome [11] 332952 0
Qualitative feedback from caregivers of intervention group participants collected via semi-strucured interviews. An interview schedule was designed with questions to evaluate the yoga intervention from the perspective of caregivers.
Timepoint [11] 332952 0
At the end of the study.

Eligibility
Key inclusion criteria
Patients who have been receiving routine haemodialysis (HD) for a period of greater than 90 days prior to trial entry; In-centre patients with a HD prescription of 3 treatment sessions per week; Patients with an arterial venous fistula or graft; Patients who are ‘haemodynamically stable’ meaning no medical intervention has been needed for hypotensive episodes and use of saline at least 2 weeks prior to trial entry; Receive a global fatigue score of -4 on the Brief Fatigue Inventory scale; Must be competent to understand the research procedures, and provide written informed consent; and Not currently practicing yoga.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ESKD patients who dialyse at home; ESKD patients who are treated with peritoneal dialysis; haemodialyis (HD) patients with catheters, including cuffed tunneled and non-cuffed non-tunneled catheters; and HD patients with concomitant conditions that in the opinion of the Chief Investigator may adversely affect the safety and efficacy of the intradialytic yoga intervention, or severely limit the patient’s ability to complete the study.

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)
A randomisation schedule will be generated by the Western Sydney University School of Science and Health Statistician, and concealed in opaque envelopes by a blinded independent researcher not involved in the testing or delivery of the study intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated undertaken by an independent researcher not involved in the testing or delivery of the intervention. Randomisation will occur on a 1:1 basis in permuted blocks. Participants will be randomised to ‘intradialytic yoga’ or ‘usual care alone’. Stratification will be by site (n = 2) and by dialysis shift (morning or afternoon shift).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this pilot randomised controlled trial (RCT), the following statistical methods will be used to perform the analyses:

a) Quantitative data will be analysed in SPSS using descriptive statistics to summarise characteristics of the sample. Measures of central tendency, dispersion, correlations and distributions will be calculated. Differences between the effect of the treatment will be tested using independent samples T Test and associated 95% confidence intervals. We will explore use of analysis of covariance (ANCOVA) and repeated measures analysis of variances (ANOVA) at follow up.
b) Qualitative data collected from follow up interviews with intervention participants and their caregivers will be analysed using thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2017
Actual
25/09/2017
Date of last participant enrolment
Anticipated
28/02/2018
Actual
5/02/2018
Date of last data collection
Anticipated
31/03/2018
Actual
31/03/2018
Sample size
Target
66
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7682 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 7683 0
North Lakes Day Hospital - North Lakes
Recruitment postcode(s) [1] 15600 0
4029 - Herston
Recruitment postcode(s) [2] 15601 0
4509 - North Lakes

Funding & Sponsors
Funding source category [1] 295893 0
University
Name [1] 295893 0
Western Sydney University, National Institute of Complementary Medicine
Country [1] 295893 0
Australia
Primary sponsor type
Individual
Name
Ms Kylie Barr
Address
Western Sydney University
National Institute of Complementary Medicine
Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 294763 0
University
Name [1] 294763 0
Western Sydney University, National Institute of Complementary Medicine
Address [1] 294763 0
Western Sydney University
National Institute of Complementary Medicine
Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country [1] 294763 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297172 0
Royal Brisbane and Women's Hospital (EC00172)
Ethics committee address [1] 297172 0
Royal Brisbane and Women's Hospital
Human Research Ethics Committee
Level 7, Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 297172 0
Australia
Date submitted for ethics approval [1] 297172 0
27/02/2017
Approval date [1] 297172 0
31/03/2017
Ethics approval number [1] 297172 0
HREC/17/QRBW/100

Summary
Brief summary
This study will be a two-group parallel design randomised controlled trial (RCT). The primary aim of this study is to evaluate the effectiveness of practicing yoga during haemodialysis (HD) (i.e. intradialytic yoga) for improving fatigue, physiological and psychological health outcomes in patients with end stage kidney disease (ESKD) receiving treatment in hospital or satellite dialysis facility settings. We hypothesise that patients with ESKD who practice intradialytic yoga for 3 sessions per week over a 12-week period will experience a 23% reduction in symptoms of fatigue by the end of the RCT period compared with usual care alone. We also hypothesise that intradialytic yoga will be associated with: reduced symptoms of post dialysis fatigue; improved quality of life; improved patient engagement in dialysis therapy plans including self care, self-management and adherence; and changes in biochemistry. Data will also be collected on participants’ beliefs about the treatment intervention, the recruitment rate, drop out rate, adherence to the intervention and safety.

Participants will be recruited from 2 dialysis facilities in Brisbane Queensland via posters, flyers and site visits by the Chief Investigator. Participation will involve attending an initial intake session during routine dialysis treatment time, followed by being randomly allocated to: 1) intradialytic yoga; or 2) usual care alone. Participants will be asked to provide consent to access confidential data recorded in medical records including medical and renal health history such as blood test results, body weight measurements and routine HD observations such as blood pressure. Participants will also be asked to complete a number of questionnaires and a post dialysis fatigue diary. These will be given at: 1) the start of the study; 2) half way (at 6 weeks); and 3) at the end of the study (week 12). Data collected from medical records and questionnaires will enable the research team to evaluate the effectiveness of the intervention for the needs of ESKD patients. Following the intervention period, participants in the intradialytic yoga group will be invited to participate in an interview to enquire about their experiences of yoga during the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73226 0
Ms Kylie Barr
Address 73226 0
Western Sydney University
National Institute of Complementary Medicine
Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 73226 0
Australia
Phone 73226 0
+61 409 992 262
Fax 73226 0
Email 73226 0
[email protected]
Contact person for public queries
Name 73227 0
Kylie Barr
Address 73227 0
Western Sydney University
National Institute of Complementary Medicine
Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 73227 0
Australia
Phone 73227 0
+61 409 992 262
Fax 73227 0
Email 73227 0
[email protected]
Contact person for scientific queries
Name 73228 0
Kylie Barr
Address 73228 0
Western Sydney University
National Institute of Complementary Medicine
Building 5, Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 73228 0
Australia
Phone 73228 0
+61 409 992 262
Fax 73228 0
Email 73228 0
[email protected]

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