| CTRI Number |
CTRI/2024/11/076613 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Physiotherapy (Not Including YOGA)
Other (Specify) [Ph. D Study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect Of Taichi and muscle Relaxation on Heart rate Variability and Physical performance in menopausal women |
|
Scientific Title of Study
|
EFFECTIVENESS OF TAI CHI AND
PROGRESSIVE MUSCLE RELAXATION ON HEART RATE VARIABILITY AND
PHYSICAL PERFORMANCE IN PERIMENOPAUSAL AND POSTMENOPAUSAL
WOMEN- A COMPARATIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Kruti Thakkar |
| Designation |
Assistant Professor |
| Affiliation |
VEER NARMAD SOUTH GUJARAT UNIVERSITY |
| Address |
Physiotherapy Department,
SPB Physiotherapy College, Ugat Bhesan Road, Surat
Surat
GUJARAT
395004
India |
| Phone |
08511917407 |
| Fax |
|
| Email |
krutithakkar8056@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Salvi Shah |
| Designation |
Associate Professor |
| Affiliation |
SPB PHYSIOTHERAPY COLLEGE, SURAT |
| Address |
Physiotherapy Department,
SPB Physiotherapy College, Ugat Bhesan Road, Surat
Surat
GUJARAT
395004
India |
| Phone |
9427800238 |
| Fax |
|
| Email |
shahsalup@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Salvi Shah |
| Designation |
Associate Professor |
| Affiliation |
SPB PHYSIOTHERAPY COLLEGE, SURAT |
| Address |
ROOM NO. 4 & 6
MUSCULOSKELETAL DEPARTMENT
SPB PHYSIOTHERAPY COLLEGE, Ugat Bhesan Road, Surat, Gujarat, India - 395004
Surat
GUJARAT
395004
India |
| Phone |
9427800238 |
| Fax |
|
| Email |
shahsalup@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRCP, UKA TARSADIA UNIVERSITY, Gopal Vidhyanagar, Bardoli, Gujarat, India - 394350 |
|
|
Primary Sponsor
|
| Name |
Dr Kruti Thakkar |
| Address |
D-4 Union Dhara Society, B/H Sarjan Society, Opp. Sargam shopping Centre, Prle Point, Surat - 395007 |
| 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 |
| Dr Kruti Thakkar |
SPB Physiotherapy College |
Physiotherapy Department in SPB College located at Ugat-Bhesan Road, Surat
Surat
GUJARAT |
08511917407
krutithakkar8056@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of SPB Physiotherapy college, Surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perimenopausal and Postmenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Specific Treatment |
NoT applicable |
| Intervention |
Progressive Muscle Relaxation |
Will provide Progressive Muscle Relaxation to perimenopausal and post-menopausal women for 12 weeks (3 days/week) |
| Intervention |
Tai Chi and Progressive Muscle Relaxation |
Will provide Tai Chi and Progressive Muscle Relaxation to perimenopausal and post-menopausal women for 12 weeks (3 days/week) |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1) For perimenopause period of amenorrhea 3-12 months with irregular frequency.
2) For the post-menopause period of more than 12 months.
3) Women should be able to participate in the follow-up intervention. |
|
| ExclusionCriteria |
| Details |
1) Women who are critically ill or currently receiving hormone therapy
2) history of medication that affects heart rate
3) Women with total hysterectomy or bilateral oophorectomy
4) Women who are not able to perform the required exercise intervention
5) Cases involving endocrine disease such as diabetes, arrhythmia or cardiovascular disease, etc.
6) Currently suffering from major illness.
7) Cases involving a history of psychological illness such as insomnia, depression, or schizophrenia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability (HRV) and Physical Performance |
Baseline and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6-minute walk test, Grip strength, Gait speed, standing balance test, Chair Stand |
15 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/08/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In this study, research will assess the effect
of Tai Chi and Progressive muscle relaxation training on the autonomic nervous system by using
HRV and also assess physical performance by using different physical tests in perimenopausal and postmenopausal women. |