| CTRI Number |
CTRI/2024/02/062219 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Resistance training and flexibility training in postmenopausal symptoms. |
|
Scientific Title of Study
|
Effect of resistance training and flexibility training in postmenopausal symptoms |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S.J Devi Jayalakshmi |
| Designation |
MPT WOMENS HEALTH |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
1-SRI RAMACHANDRA NAGAR,
PORUR,
CHENNAI
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
1-SRI RAMACHANDRA NAGAR,
PORUR,
CHENNAI-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
6374959313 |
| Fax |
|
| Email |
devijeeva.2609@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sathya Prabha |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
1-SRI RAMACHANDRA NAGAR,
PORUR,
CHENNAI.
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
1-SRI RAMACHANDRA NAGAR,
PORUR,
CHENNAI-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9677290892 |
| Fax |
|
| Email |
sathya.b@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SJ Devi Jayalakshmi |
| Designation |
MPT WOMENS HEALTH |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,1-SRI RAMACHANDRA NAGAR,PORUR,CHENNAI-600116
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,1-SRI RAMACHANDRA NAGAR,PORUR,CHENNAI-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
6374959313 |
| Fax |
|
| Email |
devijeeva.2609@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
1-SRI RAMACHANDRA NAGAR,
PORUR,
CHENNAI-600116 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [no sponsor] |
|
|
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 SJ DEVI JAYALAKSHMI |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH(Department of physiotherapy) |
DEPARTMENT OF PHYSIOTHERAPY,
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH,
1-sri ramachandra nagar,
porur.
Chennai
TAMIL NADU |
6374959313
devijeeva.2609@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
POST MENOPAUSAL WOMEN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FLEXIBILITY TRAINING |
Exercise are performed thrice a week for 12 weeks. The exercise program consists of 5 min of warm-up, 30 min of the main program, and 5 min of the cool-down,For flexibility group 2-3 rep of 20-30 sec hold of 30 minutes session. Pre & post of intervention programme |
| Intervention |
RESISTANCE TRAINING |
Exercise are performed thrice a week for 12 weeks. The exercise program consists of 5 min of warm-up, 30 min of the main program, and 5 min of the cool-down. Each resistance exercise will be repeated 10–15 times for 2–5 sets, with a 10-sec rest per repetition and 60 sec between the sets. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.The study population includes women from 45to 55 years of age.
2.Women who give consent to participate in the study.
3.Women who are having any one symptoms in MRS scale.
|
|
| ExclusionCriteria |
| Details |
1.Women who had experienced a menopause due to medical conditions such as hysterectomy, oophorectomy, radiation or chemotherapy
2.Women with mental illness and chronic disease including severe cardiovascular problems, neurological issues, severe musculoskeletal
problems, severe hypertension and diabetes mellitus.
BMI OBESE
3.pre-menopausal status
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ESTRODIOL |
PRE TEST WEEK 0
POST TEST AFTER WEEK 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MENQOL |
WEEK 0 PRE TEST VALUE
WEEK 12 POST TEST VALUE |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 2 |
|
Date of First Enrollment (India)
|
07/02/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Post- menopausal women volunteering in
this programme will be screened in Sri Ramachandra Hospital from obstetrics and
gynaecology Outpatient and Inpatient department will be taken for this study.
Based on the inclusion criteria subjects will be randomly divided into 2
groups. Group A (Experimental group) and Group B (Control group). Subjects in
both the group will be screened with Menopausal Rating Scale (MRS) and The
Menopause-specific Quality of Life Questionnaire (MENQOL) and oestrogen
analysis. Group A subjects will receive resistance exercise intervention using
TheraBand. Group B will receive flexibility exercise. Both resistance exercise
and flexibility exercise are performed thrice a week for 12 weeks. The exercise
program consists of 5 min of warm-up, 30 min of the main program, and 5 min of
the cool-down. Each resistance exercise will be repeated 10–15 times for 2–5
sets, with a 10-sec rest per repetition and 60 sec between the sets. For
flexibility group 2-3 rep of 20-30 sec hold of 30 minutes session. Pre &
post of intervention programme, subjects in both Group A and Group B will be
assessed through The Menopause-specific Quality of Life (Questionnaire (MENQOL)
and oestrogen analysis. |