| CTRI Number |
CTRI/2019/07/020135 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Diagnostic
Preventive
Other (Specify) [ Prospective randomized interventional study] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of yoga and brisk walking to prevent cardiovascular disease in post menopausal women |
|
Scientific Title of Study
|
TO STUDY THE EFFECT OF PHYSICAL ACTIVITY
(BRISK WALK VERSUS BRISK WALK WITH YOGA)
ON ATHEROGENIC INDEX OF PLASMA IN
EARLY POSTMENOPAUSAL WOMEN: A RANDOMIZED
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 |
Dr Nidhi khandelwal |
| Designation |
PG student,ruhs-cms |
| Affiliation |
RUHS-CMS, Jaipur |
| Address |
Near Shani Mandir,
Kumbha Marg, Pratap
Nagar, Sanganer,
Sector 11, Jaipur
Jaipur
RAJASTHAN
Department of Biochemistry, RUHS CMS
Kumbha Marg, Pratap
Nagar, Sanganer,
Sector 11, Jaipur
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302033
India |
| Phone |
8949853248 |
| Fax |
|
| Email |
Dr.nidhikhandelwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Sharma |
| Designation |
Professor &Head, Department of Biochemistry RUHS-CMS, Jaipur |
| Affiliation |
RUHS College of Medical Sciences, Jaipur |
| Address |
Near Shani Mandir,
Kumbha Marg, Pratap
Nagar, Sanganer,
Sector 11, Jaipur
Jaipur
RAJASTHAN
Department of Biochemistry, RUHS CMS,
Kumbha Marg, Pratap
Nagar, Sanganer,
Sector 11, Jaipur
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
sonalisharma14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi khandelwal |
| Designation |
PG student,ruhs-cms |
| Affiliation |
RUHS College of Medical Sciences, Jaipur |
| Address |
Near Shani Mandir,
Kumbha Marg, Pratap
Nagar, Sanganer,
Sector 11, Jaipur
Jaipur
RAJASTHAN
Department of Biochemistry, RUHS CMS,
Kumbha Marg, Pratap
Nagar, Sanganer,
Sector 11, Jaipur
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302033
India |
| Phone |
8949853248 |
| Fax |
|
| Email |
Dr.nidhikhandelwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajasthan University of Health Sciences, Jaipur |
|
|
Primary Sponsor
|
| Name |
RUHS CMS |
| Address |
Kumbha marg, Pratap Nagar, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Nidhi khandelwal |
RUHS College of Medical Sciences, Jaipur |
Department of Biochemistry, RUHS CMS, Near Shani Mandir,
Kumbha Marg, Pratap
Nagar, Sanganer,
Sector 11, Jaipur
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8949853248
Dr.nidhikhandelwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS-CMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
EARLY POST MENOPAUSAL WOMEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Prospective randomized interventional trial |
Intervention Group 1 (Walking )-Participants shall do brisk walk One hour /Day for 6 days in a week.
Intervention Group 2 (Walking with Yoga)- Participants shall perform Brisk walk for 20 min and Yoga for 40 min. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1)Diagnosis of menopause by a gynecologist according to STRAW study criteria and post menopausal period for up to 5 years.
2)Age group of 40–60 years.
3)Be willing and be able to practice yoga and walk.
|
|
| ExclusionCriteria |
| Details |
1)Women who are already practicing Yoga or any
known regular exercise regime.
2)Women with surgical menopause.
3)Receiving Hormonal therapy.
4)Significant cardiovascular and other co morbid disease.
5)Active psychological disorder or other
medical disorders.
6)Malignancies in the last 5 years.
7)Having major surgery scheduled within 3 month of baseline visit.
8)Orthopedic limitations.
9)Beta blockers and lipid lowering drugs. 10)Large weight loss- 20 or more kg in the past
year.
11)Alcoholism, Smoking
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess effect of Physical activity on atherogenic index of plasma (AIP) in early post menopausal women. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of various forms that is only walking and walking with Yoga on lipid profile and on atherogenic index of plasma (AIP). |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2019 |
| Date of Study Completion (India) |
09/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To our knowledge, the present study is the first prospective randomized interventional study that investigates the combined effects of two different types of LSM modalities in the form of moderate exercise i.e. walking with yoga alongwith dietary modifications. Brisk walk with yoga group shows remarkable improvement in anthropometric, hemodynamic parameters as compared to walking group in early postmenopausal women. Yoga and brisk walking improves the levels of serum glucose and lipid profile. The feedback of most of the women enrolled in walking with yoga group reported a feeling of wellbeing, more relaxed and satisfied, and a sense of more relief from anxiety. A highly significant decrease in AIP was observed in walking with yoga group as compared to walking group after intervention and can prove to be a beneficial non pharmacological intervention, in preventing development of atherosclerosis, which leads to CVD. The findings of the study demonstrate that intervention of brisk walking with yoga for 12 weeks is more effective as compared to walking for 12 weeks in improving the atherogenic index of plasma (AIP) in early postmenopausal women. |