| CTRI Number |
CTRI/2024/01/061907 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of slow pranayama on the brain |
|
Scientific Title of Study
|
Effects of slow pranayamic breathing on Neural correlates (physiological, psychological, imaging) and cardio-physiological markers in healthy subjects:A Randomized trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 7004, Convergence Block, 7th Floor, Center for Integrative Medicine and Research(CIMR)
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 7004, Convergence Block, 7th Floor, Center for Integrative Medicine and Research(CIMR)
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 7004, Convergence Block, 7th Floor, Center for Integrative Medicine and Research(CIMR)
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Center for Integrative Medicine and Research, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Center for Integrative Medicine and Research, AIIMS, New Delhi |
| Address |
Center for Integrative Medicine and Research, Room No 7004, 7th floor, Convergence Block, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gautam Sharma |
Center for Integrative Medicine and Research, AIIMS |
Room No. 7004, 7th Floor, Convergence Block, Center for Integrative Medicine and Research(CIMR), AIIMS
South
DELHI |
01126549326
drgautamsharma12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breath awareness for 2 months |
Participants will be asked to: 1. Sit in a quiet corner 2. Relax themselves 3. Focus on their breath 4. Keep a mental count of their breath The participants will be asked to sit in a cross-legged posture (sukhasana) with eyes gently closed and be consciously aware of their breathing pattern while breathing at a spontaneous (physiological) rate. Rounds: 10 -12 rounds Time: 15 minutes/session Frequency: 6 days/week Physical contact session: 3 days in the first week and then 1 day/week (can be adjusted as per convenience) Online guided session: 5 days/week (all the subjects will be encouraged to visit for physical contact sessions rather than online sessions if feasible) |
| Intervention |
Slow pranayama breathing module for 2 months |
Participants will be asked to:
1. Sit in a quiet corner.
2. Relax.
3. Focus on their breath.
4. Keep a mental count of their breath.
Nadi Shodhana Pranayama (Alternate nostril breathing) without retention- Position: Sit in a cross-legged posture (sukhasana) with eyes gently closed. The left hand in the chin mudra (index finger and thumb joined) is on the left knee. Right hand in Nasika mudra (index and middle fingers bent). Steps Gently close the right nostril with the right thumb, slowly breathing in through the left nostril. Using your right ring finger, close your left nostril and lift your thumb up to slowly breathe out through the right nostril. Then inversely, breathe in through the right nostril and breathe out through the left nostril. This constitutes one round of the pranayama. Breathing: The breathing has to be gentle and rhythmic without any force. The traditionally prescribed inhalation to exhalation ratio of 1:2 would be recommended using personalized approach by taking into consideration subject’s comfort level while performing the pranayama (approx. 6-8bpm). The focus should be maintained on the speed and depth of breathing. Rounds: 10 -12 rounds (Beginner’s Level -1) Time: 15 minutes/session Frequency: 6 days/week Physical contact session: 3 days in first week and then 1 day/week (can be adjusted as per convenience) Online guided session: 5 days/week (all the subjects will be encouraged to visit for physical contact sessions rather than online sessions if feasible) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adults between 18 to 55 years
Education: Secondary or higher
Naïve to pranayamic or any yoga practices
Willingness to participate
|
|
| ExclusionCriteria |
| Details |
Any contraindications to MRI, including MRI- incompatible implants
Regular use of stimulants or any other drug that affects cardiac modulation
H/o any systemic illness or psychiatric illness
Pregnancy
Performs meditation/yoga regularly
Claustrophobia
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the shift in EEG power spectra
To assess stress reduction by utilizing the Perceived Stress Scale
|
Baseline assessment and 8 weeks FU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in fMRI activity (subset of subjects) |
Baseline assessment and 8 weeks FU |
| Changes in fMRI connectivity (subset of subjects) |
Baseline assessment and 8 weeks FU |
| Changes in structural MRI measures (subset of subjects) |
Baseline assessment and 8 weeks FU |
| To assess the changes in the Positive and Negative Affect Scale (PANAS) |
Baseline assessment and 8 weeks FU |
| To assess the changes in scores of STAI scale |
Baseline assessment and 8 weeks FU |
| To assess the changes in the Scales of psychological well-being |
Baseline assessment and 8 weeks FU |
| To evaluate the shift in autonomic nervous system parameters (Holter monitoring) |
Baseline assessment and 8 weeks FU |
| To evaluate changes in beat-to-beat blood pressure |
Baseline assessment and 8 weeks FU |
| To evaluate changes in the skin conductance test |
Baseline assessment and 8 weeks FU |
| To evaluate changes in the resting metabolic rate |
Baseline assessment and 8 weeks FU |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to understand the effects of slow pranayamic breathing on reducing stress by studying the underlying mechanism of the proposed benefits on the brain and cardiac physiology along with the neuropsychological well-being of healthy participants as compared to the active control group/ comparator arm- breath awareness exercise (physiological rate). The subjects will be recruited by posting advertisements on social media and around the AIIMS hospital campus. It is a prospective, randomized, open-label, blinded endpoint, parallel assignment of 70 subjects (MRI of only 24 subjects i.e. 12 per arm will be done). The subjects will be randomized into two groups: Study intervention group- Slow pranayamic breathing and Active control group: Breath Awareness (at the physiological rate). Assessment will be made at the baseline and at 8 weeks. This will be the first RCT with an 8-week follow-up, which may advocate improvement in healthy individuals’ perceived stress, neuro-electrophysiological and related neuro-imaging correlates, emotional/negative affect coping functional status and cardio-physiological correlates. The outcome measures will be a shift in EEG power spectra along with a reduction in scores on the perceived stress scale. The secondary outcome measures will be changes in fMRI activity, connectivity, and structural MRI measures (in a subset of subjects- 12 per arm); improvement in PANAS, STAI, SPWB, Holter, beat-to-beat blood pressure, skin conductance test and resting metabolic rate.
|