| CTRI Number |
CTRI/2011/091/000078 [Registered on: 17/01/2011] |
| Last Modified On: |
27/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Deep breathing exercises] |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of deep slow breathing exercises in healthy subjects |
Scientific Title of Study
Modification(s)
|
Effect of deep slow breathing exercises on spontaneous respiratory rate and short-term heart rate variability. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Elizabeth Tharion |
| Designation |
|
| Affiliation |
|
| Address |
Department of Physiology
Christian Medical College
Vellore
TAMIL NADU
632002
India |
| Phone |
04162284268 |
| Fax |
04162262788 |
| Email |
e.tharion@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Elizabeth Tharion |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor, Department of Physiology, Chritian Medical College, Vellore. |
| Address |
Department of Physiology
Christian Medical College
Vellore
TAMIL NADU
632002
India |
| Phone |
04162284268 |
| Fax |
04162262788 |
| Email |
e.tharion@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Elizabeth Tharion |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Physiology
Christian Medical College
Vellore
TAMIL NADU
632002
India |
| Phone |
04162284268 |
| Fax |
04162262788 |
| Email |
e.tharion@cmcvellore.ac.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Christian Medical College, Vellore |
|
Primary Sponsor
Modification(s)
|
| Name |
Christian Medical College |
| Address |
Vellore
Tamil Nadu
India 632002 |
| Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Elizabeth Tharion |
Department of Physiology |
Department of Physiology,Christian Medical College-632002
Vellore
TAMIL NADU |
04162284268
04162262788
e.tharion@cmcvellore.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cardio-respiratory interaction and integration in health, or specifically, the effect of respiration on cardiac autonomic control in healthy subjects. |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Deep slow breathing exercise |
Done daily for 30 minutes for 30 days |
| Comparator Agent |
Nil intervention |
Not applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age of 20 to 40 years, BMI of 19 to 25, Physical activity level of sedentary to moderate as per a questionnaire |
|
| ExclusionCriteria |
| Details |
(1) Any chronic respiratory or cardiovascular diseases (2) Diabetes (3) Known autonomic neuropathy (4) Those on long-term medications (5) Chronic smokers, tobacco chewers/sniffers and alcoholics (6) Pregnant women (8) Women with surgical or natural menopause (9) Those already performing some form of yoga or breathing exercises
These will be determined using a pre-test questionnaire.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Respiratory rate |
After one month |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Short-term heart rate variability indices |
After one month |
|
Target Sample Size
Modification(s)
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
03/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/09/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Tharion E, Samuel P, Rajalakshmi R, Gnanasenthil G, Subramanian RK. Influence of deep breathing exercise on spontaneous respiratory rate and heart rate variability: a randomised controlled trial in healthy subjects.Indian J Physiol Pharmacol. 2012 Jan-Mar;56(1):80-7. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study was a randomised controlled trial where 36 healthy volunteers of both genders in the age group of 20 to 40 years was recruited and then randomised into an intervention group and control group in a 1:1 ratio. The intervention group was required to perform deep slow breathing excercise daily for one month, while the control group did not perform any breathing exercise. The primary outcome was any change in the spontaneous breathing rate after one month. The secondary outcome was any change in the short-term heart rate varibility indices after one month. |