| CTRI Number |
CTRI/2021/12/038591 [Registered on: 13/12/2021] Trial Registered Prospectively |
| Last Modified On: |
11/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of Tai Chi exercise on post menopausal working women |
|
Scientific Title of Study
|
“Effectiveness of Tai Chi exercise program on Sleep, Quality of life and
Physical performance in post-menopausal working women: An
experimental study.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Rajkumar Jain |
| Designation |
Post graduate physiotherapy student |
| Affiliation |
MGM Institute of physiotherapy |
| Address |
MGM Institute of physiotherapy community department opd no7 , gate no 3 , N 6 cidco , aurangabad, maharashtra
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09960723393 |
| Fax |
|
| Email |
jayushi317@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakash Doss |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of physiotherapy |
| Address |
MGM Institute of Physiotherapy Community Department opd no 7 gate no 3 N 6 cidco Aurangabad Maharashtra
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9886386726 |
| Fax |
|
| Email |
dossprakashs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayushi Rajkumar Jain |
| Designation |
Post graduate physiotherapy student |
| Affiliation |
MGM Institute of physiotherapy |
| Address |
MGM Institute of physiotherapy community department opd no7 , gate no 3 , N 6 cidco , aurangabad, maharashtra
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09960723393 |
| Fax |
|
| Email |
jayushi317@gmail.com |
|
|
Source of Monetary or Material Support
|
| sleep quality scale
physcial performance test
WHO QOL BREF |
|
|
Primary Sponsor
|
| Name |
MGM Institute of physiotherapy |
| Address |
MGM Institute of physiotherapy community department n6cidco Aurangabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ayushi jain |
MGM institute of physiotherapy Aurangabad |
Mgm institute of physiotherapy community department opd number 7 gate number 3 n6 cidco aurangabad
Aurangabad
MAHARASHTRA |
09960723393
jayushi317@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post menopausal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tai chi exercise program |
Tai Chi Pouring, Swinging, Drumming and standing
Swinging to connect the kidneys and lungs
Hip Circles, Spiraling the lower extremities, Spinal Cord Breathing, Fountain, Washing yourself with QI from the Heavens, push and withdraw, wave hand like clouds , grasp the sparrow tail, brush knee twist step given three times a week for eight weeks |
|
|
Inclusion Criteria
|
| Age From |
42.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Female |
| Details |
Subject willing to participate in study with signed informed consent
Female subjects who are working in tertiary care hospital
Women’s who have experienced 12 consecutive months of amenorrhea
|
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with insomnia
Subjects with any recent injuries or major surgeries
Subjects with any menstrual abnormalities
Subjects with surgical menopause
Psychologically compromised subject
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
WHO quality of life BREF
Sleep quality scale
|
10min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical performance test |
20 min |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/12/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Planned for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM- to evaluate the effect of Tai Chi on improving sleep, quality of life and physical performance in post-menopausal working women. Study design - experimental study Study setting - tertiary level hospital care setting Study population- working women Method- All the participants with menopause who are employed in tertiary care hospital are selected as per the inclusion and exclusion criteria. Written consent form will be obtained. They will be assessed for Quality of life, Physical performance and Sleep before the Tai Chi program in incorporated. After the measures are taken accordingly the participants will receive Tai Chi exercise program for 8 weeks period. Participants are evaluated for post-test assessment. The data will be analyzed accordingly. The exercise like - Tai Chi Pouring , Swinging, Drumming and standing, Swinging, Hip Circles, Spiraling the lower extremities, Spinal Cord Breathing, Fountain, Washing yourself with QI from the Heavens Push and withdraw, wave hand like cloud , grasp sparrow tail, brush knee twist hip Result- ongoing study. Conclusion - effectiveness of Tai Chi exercise program on sleep, quality of life and physical performance in post Menopasual working women will be seen . |