| CTRI Number |
CTRI/2018/01/011382 [Registered on: 17/01/2018] Trial Registered Prospectively |
| Last Modified On: |
16/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga effect on cognitive performance in male and female |
|
Scientific Title of Study
|
Investigating differences in mindfulness and neurocognitive performance between male and female yoga and non-yoga practitioners: a case control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepeshwar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekananda Yoga University (S-VAYSA) |
| Address |
Department of Yoga and Life Sciences 19 Eknath Bhavan, Gavipuram Circle,
K.G. Nagar Bangalore KARNATAKA 560019 India |
| Phone |
9036367402 |
| Fax |
|
| Email |
deepeshwar.singh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Deepeshwar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekananda Yoga University (S-VAYSA) |
| Address |
Department of Yoga and Life Sciences 19 Eknath Bhavan, Gavipuram Circle,
K.G. Nagar
KARNATAKA 560019 India |
| Phone |
9036367402 |
| Fax |
|
| Email |
deepeshwar.singh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kiran Menon |
| Designation |
MSc Scholar |
| Affiliation |
Swami Vivekananda Yoga University (S-VAYSA) |
| Address |
Department of Yoga and Life Sciences 19 Eknath Bhavan, Gavipuram Circle,
K.G. Nagar Bangalore KARNATAKA 560019 India |
| Phone |
9036367402 |
| Fax |
|
| Email |
kiran007menon@gmail.com |
|
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Source of Monetary or Material Support
|
| Swami Vivekananda Yoga University, Department of Yoga and Cognitive Neuroscience, 19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga University |
| Address |
Department of Yoga and Cognitive Neuroscience, 19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepeshwar Singh |
Swami Vivekananda Yoga University |
Division of Yoga and Life Sciences, Yoga and Cognitive Neuroscience, 19 Eknath Bhavna, Gavipuram Circle, K.G. Nagar, Bengaluru. Bangalore KARNATAKA |
9036367402
deepeshwar.singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of S-VYASA University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Male and Female Participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
This group participants will not have any yoga experience. |
| Intervention |
Yoga Group |
All participants in Yoga Group will have minimum 24 month experience |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Yoga Group (YG) participants will be consisted of students of graduate, postgraduate and yoga therapists with a minimum of two years’ experience and resident of the yoga center and routine yogic lifestyle.
2. Non-Yoga Group (NY) participants will be recruited from nearby medical college students and while selection they should be non-smokers or a non-alcoholic, vegetarian diet.
3. All participants will be screened to rule out possible cognitive deficiency using the Mini-Mental State Examination with a cut-off score 27. |
|
| ExclusionCriteria |
| Details |
1. Any participant with the neurological or psychiatric problems.
2. Smoking, drugs etc.
3. Any medication which influences cognitive functions. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Visual n-back task,
2. Color-Word Stroop Task, and
3. Running memory span,
|
Day 1 and Day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Positive and Negative Affect Schedule (PANAS),
2.The Freiburg Mindful Inventory [FMI],
3. State-Trait Anxiety Inventory (STAI),
4. Positive states of mind (POSM), and
5. Perceived stress scale (PSS-10) |
Day 3 and Day 4 |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 1 |
|
Date of First Enrollment (India)
|
25/01/2018 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Existing research on yoga intervention demonstrates a beneficial effect on general well-being and physical health among yoga practitioners of both genders. But these investigations are mainly focused on the short or long-term intervention of yoga. To date, however, the effectiveness of regular yoga practice in improving psychological well-being and neurocognitive performance of both gender has not been examined. The primary focus of this study was gender-based yoga practice effect on neurocognitive functions and secondary focus was on the difference with matched non-practitioners. Therefore, the present study intended to investigate gender differences in mindfulness and neurocognitive performance between male and female yoga practitioners and non-practitioners. We hypothesized that i) the female yoga practitioners would result in lowered state and trait anxiety and perceived stress than male yoga practitioners, ii) the male yoga practitioners would have higher neurocognitive performance but females would result in higher accuracy and iii) yoga practitioners would have higher mindfulness and neurocognitive performance than non-practitioners. |