| CTRI Number |
CTRI/2017/07/008973 [Registered on: 05/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effect of a breathing training programme on quality of life in patients with Chronic Kidney Disease (Pre-dialysis) |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effect of a breathing training programme on quality of life in patients with Chronic Kidney Disease ( Pre-dialysis) attending Nephrology OPD in PGIMER, Chandigarh, 2015-2017 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LASARA KHARBTENG |
| Designation |
Student |
| Affiliation |
NATIONAL INSTITUTE OF NURSING EDUCATION |
| Address |
National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, sector-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9089338867 |
| Fax |
|
| Email |
lasarakbteng@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monaliza Mittal |
| Designation |
Lecturer |
| Affiliation |
NATIONAL INSTITUTE OF NURSING EDUCATION |
| Address |
National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, sector-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914477603 |
| Fax |
|
| Email |
monaliza.mittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
LASARA KHARBTENG |
| Designation |
Student |
| Affiliation |
NATIONAL INSTITUTE OF NURSING EDUCATION |
| Address |
National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, sector-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9089338867 |
| Fax |
|
| Email |
lasarakbteng@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
LASARA KHARBTENG |
| Address |
National Institute of Nursing Education, Postgraduate Institute of
Medical Education and Research, Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR SANDHYA GHAI |
Principal, National Institute of Nursing Education,
PGIMER, Chandigarh. |
| DR SUKHPAL KAUR |
Lecturer, NINE, PGIMER, Chandigarh |
| DR VIVEK KUMAR |
Assistant Professor, Department of Nephrology, PGIMER, Chandigarh |
| MS MONALIZA MITTAL |
Lecturer, NINE, PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| LASARA KHARBTENG |
Postgraduate Institute of Medical Education and Research |
New OPD,Room no 3023/3070,3rd floor,Department of Nephrology
Chandigarh
CHANDIGARH |
9089338867
lasarakbteng@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CKD patients with eGFR between 15-45 ml/min/1.73m2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breathing training programme |
Breathing training programme consist of three breathing exercises i.e., alternate nostril breathing, 4-7-8 breathing and breath counting which was taught with the help of a video. The first practice session was demonstrated by the researcher. The subjects were then asked to perform return demonstration which was evaluated by the researcher for correct technique. The subjects were provided with a pre- recorded video with which they can perform the remaining sessions. They were asked to practice breathing exercises for 5 minutes thrice daily at home.
Frequency- thrice daily.
Number of sessions- 3 times a day for 4 weeks, i.e., total 90 sessions.
How long each session- 5 mins.
Total intervention- 4 weeks intervention period with total 15 minutes per day.
|
| Comparator Agent |
Routine care |
Follow up, medication, biophysiological monitoring |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years
Clinically stable course for last 1 month |
|
| ExclusionCriteria |
| Details |
CKD patients on dialysis
Pregnant or lactating females |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Kidney disease quality of life score |
23-07-2016 to 3-10-2016 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/07/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to assess the effect of a breathing training program on quality of life in patients with Chronic Kidney Disease (Pre-dialysis).
Hypothesis:
Null hypothesis : There is no significant effect of a breathing training program on quality of life in patients with Chronic Kidney Disease (Pre-dialysis) at 0.05 level of significance.
Alternate hypothesis : There is significant effect of a breathing training
program on quality of life in patients with Chronic Kidney Disease
(Pre-dialysis) at 0.05 level of significance.
|