Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001373561
Ethics application status
Approved
Date submitted
22/10/2015
Date registered
16/12/2015
Date last updated
16/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of breathing exercises on dialysis related symptoms among end stage renal disease (ESRD) patients undergoing hemodialysis
Scientific title
The effect of breathing exercises on dialysis related symptoms among ESRD patients undergoing hemodialysis
Secondary ID [1] 287452 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal disease requiring hemodialysis 296173 0
Condition category
Condition code
Renal and Urogenital 296452 296452 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A certified Yoga instructor taught the respondents the three breathing techniques and the training were done in a group, they attended one session for around 30 to 40 minutes for each one participant. The respondents were divided into four groups; two groups for those who come for dialysis on Monday, Wednesday and Friday another two groups for those who come for dialysis on Tuesday, Thursday and Saturday. The overall duration of the intervention period it will be 8 weeks.
The respondents were gathered in the waiting room in the dialysis center to learn breathing exercise. It was easy to gather them because dialysis patients usually come early for dialysis. The training was done prior to their dialysis session. The respondents were taught a holistic breathing technique which consist of three techniques. First technique is respondents have to focus on their natural breathing with the goal of maintaining continuity of awareness, second technique is "Ujjayi" or "Victorious Breath" Emphasizing simple, long-exhalation breathing, with a focus on slow, even exhalation approximately two times longer than the inhalation. The third technique is alternate nostril breathing, "nadi shodhana"; this technique involved moving air through alternate nostrils. The Participants were told to practice all the three breathing techniques in an order that they please for 20 minutes each dialysis section.
The strategies used to monitor adherence to the intervention is participant diary activities during dialysis sections.
Intervention code [1] 292824 0
Treatment: Other
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296068 0
To determine the effects of breathing exercise in reducing number of symptoms and level of symptom severity among patients undergoing hemodialysis. (composite outcomes)
The outcome was assess by using Dialysis Symptoms Index (DSI) questionnaire.
Timepoint [1] 296068 0
Baseline before intervention, then 8 weeks on completion of intervention.
Secondary outcome [1] 317424 0
To determine the prevalence of symptom in hemodialysis patients.
The outcome was assess by using Dialysis Symptoms Index (DSI) questionnaire.
Timepoint [1] 317424 0
Baseline before intervention, then 8 weeks on completion of intervention.
Secondary outcome [2] 317425 0
To determine the level of symptom severity in hemodialysis patients.
The outcome was assess by using Dialysis Symptoms Index (DSI) questionnaire.
Timepoint [2] 317425 0
Baseline before intervention, then 8 weeks on completion of intervention.
Secondary outcome [3] 317428 0
To determine the association between demographic variable gender, age, marital status and educational level and severity score.
The outcome was assess by using demographic questionnaire designed specifically for this study and Dialysis Symptoms Index (DSI) questionnaires.
Timepoint [3] 317428 0
Baseline before intervention, then 8 weeks on completion of intervention.

Eligibility
Key inclusion criteria
All patient undergoing chronic hemodialysis treatment, dialyzing via permanent vascular access such as arteriovenous fistula, graft and permanent catheter were included for the study. The age limit was 18 years and above for the purpose of consent. Patient should have dialysis adequacy (kt/v) of more than 1.0 this is to ensure that patient is adequately dialyzed. Therefore the patients should be dialyzed regularly for more than 6 months to ensure the availability of dialysis adequacy (kt/v) result. Patient should have blood pressure within normal range and Hb above 10gm/dl.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with active infection, evidence of fluid overload such as short of breath at rest, those who were involved in any kind of breathing exercises were excluded from this study.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2013
Date of last participant enrolment
Anticipated
Actual
12/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
47
Recruitment outside Australia
Country [1] 7157 0
Malaysia
State/province [1] 7157 0
Petaling Jaya

Funding & Sponsors
Funding source category [1] 292021 0
University
Name [1] 292021 0
University of Malaya Research Grant
Country [1] 292021 0
Malaysia
Primary sponsor type
Individual
Name
LINGESWARI VASUDEVAN
Address
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 290691 0
None
Name [1] 290691 0
Address [1] 290691 0
Country [1] 290691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293737 0
Medical Ethics Committee, University Malaya Medical Center
Ethics committee address [1] 293737 0
Ethics committee country [1] 293737 0
Malaysia
Date submitted for ethics approval [1] 293737 0
25/10/2012
Approval date [1] 293737 0
21/11/2012
Ethics approval number [1] 293737 0

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

Contacts
Principal investigator
Name 60178 0
Mrs LINGESWARI VASUDEVAN
Address 60178 0
Department of Nursing Science, Faculty of Medicine, University of Malaya,
50603 Kuala Lumpur, Malaysia.
Country 60178 0
Malaysia
Phone 60178 0
+60182127207
Fax 60178 0
Email 60178 0
[email protected]
Contact person for public queries
Name 60179 0
LINGESWARI VASUDEVAN
Address 60179 0
Department of Nursing Science, Faculty of Medicine, University of Malaya,
50603 Kuala Lumpur, Malaysia.
Country 60179 0
Malaysia
Phone 60179 0
+60182127207
Fax 60179 0
Email 60179 0
[email protected]
Contact person for scientific queries
Name 60180 0
Chong Mei Chan
Address 60180 0
Department of Nursing Science, Faculty of Medicine, University of Malaya,
50603 Kuala Lumpur, Malaysia.
Country 60180 0
Malaysia
Phone 60180 0
+603-79493675
Fax 60180 0
Email 60180 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.