| CTRI Number |
CTRI/2023/06/053485 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [yoga therapy] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of yoga on recovery stress and mental toughness in competitive swimmers |
|
Scientific Title of Study
|
Effect of yoga on recovery stress and mental toughness in competitive swimmers: A randomized control trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshitha J |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute of Mental Health and Neuroscie |
| Address |
Third floor, yoga center new building, Department of Integrative Medicine, NIMHANS
Bangalore, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
8197724152 |
| Fax |
|
| Email |
harshithaj1220@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishitha Jasti |
| Designation |
Scientist-B |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
Frist floor, ayurveda block, Department of Integrative Medicine, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
8762150803 |
| Fax |
|
| Email |
nishitha.jasti910@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharath Holla |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
Frist floor, Ayurveda block, Department of Integrative Medicine, NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9844259459 |
| Fax |
|
| Email |
hollabharath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Integrative Medicine, Yoga centre, NIMHANS, Bangalore, Karnataka 560027. |
|
|
Primary Sponsor
|
| Name |
Harshitha J |
| Address |
Third floor, yoga center new building, Department of Integrative Medicine, NIMHANS
Bangalore, Karnataka |
| Type of Sponsor |
Other [self ] |
|
|
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 |
| Harshitha J |
Basavanagudi Aquatic Center |
Corporate Swimming Pool, Pampamahakavi Road Sankarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA |
09483883252
harshithaj1220@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Basavanagudi Aquatic Center |
Approved |
| Human Ethics Committee for Research in AYUSH and Integrative Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Competitive swimmers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
waitlist control |
The control group does not receive any yoga module, they will remain as a waiting list. We will take pre-post recovery stress questionnaire (RESTQ), sports mental toughness questionnaire (SMTQ), and heart rate recovery (HRR) |
| Intervention |
yoga |
The intervention is for 4 weeks. During the intervention period yoga session will be conducted for a duration of 40 min, 4 days a week. we will take a pre-post of recovery stress questionnaire (RESTQ), sports mental toughness questionnaire (SMTQ), and heart rate recovery (HRR) |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
competitive swimmers participated in the district/state/national/international competitions. |
|
| ExclusionCriteria |
| Details |
-subjects undergoing physiotherapy
-subjects undergoing relaxation training
-subjects undergoing sports counseling
-subjects undergoing massage therapy
- substance use |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| recovery stress questionnaire for Athletes (RESTQ sport) |
Pre (0 days) and post (after 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-sports mental health questionnaire (SMTQ)
-Heart Recovery Rate (HRR) |
Pre (0 days) and post (after 4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/06/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The subjects will be screened and assessed for eligibility. The study is a randomized control trial, where subjects are randomized based on cluster. The intervention group is given a yoga module for 4 weeks i.e. 4 sessions per week and another group will be waitlist control. The assessment will be done at baseline and at end of the intervention. Safety assessments and adverse events will be monitored and appropriately documented for the duration of the study period. |