| CTRI Number |
CTRI/2022/10/046589 [Registered on: 18/10/2022] Trial Registered Prospectively |
| Last Modified On: |
04/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yogic Sukshma Vyayama on Spine-Shoulder Range of Motion, Cardiovascular Functions and Lung Capacities |
|
Scientific Title of Study
|
Effect of Yogic Sukshma Vyayama on Spine-Shoulder Mobility and Cardio-Pulmonary Functions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidheesh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, University of Patanjali, Haridwar, Uttarakhand, India-249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9313186405 |
| Fax |
|
| Email |
nidheesh@uop.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipin Kumar Rathore |
| Designation |
Research Scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, University of Patanjali, Haridwar, Uttarakhand, India-249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7906061226 |
| Fax |
|
| Email |
vipinkumar980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipin Kumar Rathore |
| Designation |
Research Scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, University of Patanjali, Haridwar, Uttarakhand, India-249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7906061226 |
| Fax |
|
| Email |
vipinkumar980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of yoga science, University of Patanjali, Haridwar Uttarakhand, India-249405 |
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
University of Patanjali, Haridwar, Uttarakhand, India-249405 |
| Type of Sponsor |
Other [University ] |
|
|
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 |
| Vipin Kumar Rathore |
University of Patanjali |
Department of yoga
science, University of
Patanjali, Haridwar
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
7906061226
vipinkumar980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, University of Patanjali, Haridwar, Uttarakhand |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
No treatment |
| Intervention |
Yogic Sukshma Vyayama |
60 minutes in a day/ six days a week for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
1. Those were ready to give written consent.
2. Those were between 18-25 years.
3. Those were apparently healthy on history and clinical examination.
|
|
| ExclusionCriteria |
| Details |
1. Those who had BMI < 18.5 or > 24.99
3. Those were on any drugs that affect cardiopulmonary functions.
4. Those had any disease/disorder that can affect the respiratory or cardiovascular system.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Spine range of motion
2. Shoulder range of motion
3. Chest wall expansion
4. Cardiovascular Function
5. Pulmonary Function |
At (i)Baseline and (ii) Post assessment (After 12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this research is to assess the effect of Yogic Sukshma Vyayama on Spine-shoulder mobility, Chest wall expansion, and Cardiopulmonary Functions in young adults. Participants will be divided into two groups with 40 subjects in both (i) experimental group and (ii) control group. The experimental group will be given the regular practice of yogic Sukshma Vyayama at the same time of the day for 12 weeks (each day 60 minutes of practice) and on the other side control group would remain without intervention.
|