| CTRI Number |
CTRI/2020/08/027389 [Registered on: 26/08/2020] Trial Registered Prospectively |
| Last Modified On: |
20/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yogic exercise and treadmill exercise on cardio-respiratory parameters |
|
Scientific Title of Study
|
Comparative study of yogic exercise and treadmill exercise on resting heart rate variability and VO2 max in undergraduate medical students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Meshram |
| Designation |
Associate Professor |
| Affiliation |
DMIMS(DU),Wardha |
| Address |
Department Of Physiology,Jawaharlal Nehru Medical College,Sawangi(M),Wardha.
Datta Meghe Institute Of Medical Science(DU),Sawangi(M),Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709898794 |
| Fax |
|
| Email |
meshram.komal3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DABiswas |
| Designation |
Professor & HOD |
| Affiliation |
DMIMS(DU),Wardha |
| Address |
Department Of Physiology,Jawaharlal Nehru Medical College,Sawangi(M),Wardha.
Datta Meghe Institute Of Medical Science(DU),Sawangi(M),Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822562940 |
| Fax |
|
| Email |
dalia_biswas@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Meshram |
| Designation |
Associate Professor |
| Affiliation |
DMIMS(DU),Wardha |
| Address |
Department Of Physiology,Jawaharlal Nehru Medical College,Sawangi(M),Wardha.
Datta Meghe Institute Of Medical Science(DU),Sawangi(M),Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709898794 |
| Fax |
|
| Email |
meshram.komal3@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMIMS(DU),Sawangi(M),Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Dr Komal Meshram |
| Address |
Associate Professor,Dept of Physiology. JNMC,Sawangi(M)Wardha |
| 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 |
| DrKomal Meshram |
DMIMS(DU) |
Dept Of Physiology,JNMC,Sawangi,Wardha
442001
Wardha
MAHARASHTRA |
7709898794
meshram.komal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIMS Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal participants,no addiction to smoking,alcohol.Not having any chronic diseases,COPD,CVS disease,DM,HT,any psychiatric illness.Not undergone any surgical procedure in previous 6 months. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Treadmill exercise |
Treadmill exercise of moderate intensity will be given for 35 mins,5 times/wk for 6 months. |
| Intervention |
Yogic exercise |
Yogic exercise consisting of asana,pranayama and meditation of moderate intensity will be given for 35 minutes,5 times/week for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Male |
| Details |
1. First year MBBS male students from Jawaharlal Nehru Medical College, Sawangi (M), Wardha.
2. Participants who had volunteered
3. Participants who had given written consent.
|
|
| ExclusionCriteria |
| Details |
1.Previous experience of yogic or treadmill training.
2. Addiction to smoking and drinking.
3. Suffering or diagnosed with any chronic diseases.
4. Participants with Chronic Obstructive Pulmonary Disease, cardiovascular disorder, hypertension or diabetes.
5. Participants suffering from any psychiatric illness.
6. Recent surgical procedures during the previous 6 months.
7. Participants not giving consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post intervention changes in Heart rate variability and VO2 max will be estimated and compared. |
At every 2 months interval till 6 months of intervention all parameters will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General well being will be assessed by WHO-QOL score |
Before intervention as baseline and after 6 months of intervention. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/09/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomized,open label,parallel group trial comparing the effects of yogic exercise and treadmill exercise on resting heart rate variability, VO2 max and general well-being for six months in undergraduate medical students. Present study will be conducted in India for one and a half year duration.Primary outcome measures will be resting heart rate variability,VO2 max while secondary outcome measures will be general well-being assessed by WHO-QOL domains. |