| CTRI Number |
CTRI/2024/05/066647 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Modified Chair Suryanamaskar on body composition, bodys ability to uptake oxygen and quality of life in Postmenopausal Women
|
|
Scientific Title of Study
|
Effect of Modified Chair Suryanamaskar on body composition, aerobic capacity and quality of life in Postmenopausal Women -A Randomised Control Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Sojrani |
| Designation |
Post Graduate Resident |
| Affiliation |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy,Department Of Community Physiotherapy, 11/12,Thube Park ,Shivajinagar,Pune,411005
Pune
MAHARASHTRA
411005
India |
| Phone |
7620587344 |
| Fax |
|
| Email |
divyajhalak13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apurv Shimpi |
| Designation |
Principal and Professor |
| Affiliation |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy,Department Of Community Physiotherapy,11/12,Thube Park ,Shivajinagar,Pune,411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9890183195 |
| Fax |
|
| Email |
apurv008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apurv Shimpi |
| Designation |
Principal and Professor |
| Affiliation |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy,Department Of Community Physiotherapy, 11/12,Thube Park ,Shivajinagar,Pune,411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9890183195 |
| Fax |
|
| Email |
apurv008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy,Department of Community Physiotherapy,11/12 Thube Park,Shivajinagar,Pune,Maharashtra,India, 411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute For Orthopaedics and Rehabilitation College of Physiotherapy 11/12,Thube Park ,Shivajinagar,Pune,411005 |
| Type of Sponsor |
Private 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 |
| Divya Sojrani |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of Community Physiotherapy, 11/12- Thube Park,Shivajinagar,Pune-411005
Pune
MAHARASHTRA |
7620587344
divyajhalak13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postmenopausal women
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Information Brochure |
The control group will receive Information Brochure about different modes of exercises |
| Intervention |
Modified Chair Suryanamaskar |
The experimental group will be given Modified chair suryanamaskar till RPE is reached 6 according to Modified Borg scale for 5 days per week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
BMI greater than or equals to 25 kg/sq.m |
|
| ExclusionCriteria |
| Details |
Women who have suffered major cardiovascular event in past 6 months
Recent Upper or lower extremity fracture
Recent Hysterectomy
Hormone therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rockport test (VO2 max) |
At baseline (0 week)
Post Intervention (6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bioelectrical Impedance Analysis(BIA) |
At baseline (0 week)
Post Intervention (6 weeks) |
| Menopause specific Quality Of Life(MENQOL) |
At baseline (0 week)
Post Intervention (6 weeks) |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
11/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Menopause is defined as the permanent cessation of menstrual periods. During menopausal transition, there is a lot of fluctuation in the hormonal levels and thus women may experience many symptoms and conditions. Some women have severe symptoms that profoundly affect their personal and social functioning, and quality of life (QOL). Suryanamaskar is a part of yoga which is an ancient Indian form of physical activity . It is a sequence of 12 yogic asanas. It is now applied as a complementary treatment for many health issues. The practice of suryanamaskar is highly effective for physical, mental and spiritual health. Modified chair suryanamaskar is effective in weight management and improving physical fitness in overweight and obese females. It is also effective in improving cardiovascular fitness, upper limb muscle endurance and body flexibility in overweight and obese females. Research Hypothesis: Practice of Modified Chair Suryanamaskar will have significant effects on body composition, aerobic capacity and quality of life in postmenopausal women. Null Hypothesis: Practice of Modified Chair Suryanamaskar will have no significant effects on body composition, aerobic capacity and quality of life in postmenopausal women. |