| CTRI Number |
CTRI/2024/06/068743 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| 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
|
Improving Work and Quality of Life for Perimenopausal Women through education and Training |
|
Scientific Title of Study
|
Evaluation of Work Performance and Quality Of Life among Perimenopausal Women through Perception, Education and Training (PET): A Randomized Controlled 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 |
Nain Dos Santos Gomes |
| Designation |
Post Graduate Student |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8552991324 |
| Fax |
|
| Email |
naingomes68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Ruchita Narsia |
| Designation |
Assisstant professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9408956388 |
| Fax |
|
| Email |
ruchita.narsia@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Ruchita Narsia |
| Designation |
Assisstant professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9408956388 |
| Fax |
|
| Email |
ruchita.narsia@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy, Nitte (Deemed to be university) , Mangalore, Karnataka -575018, India |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy, Nitte Deemed to be University |
| Address |
Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru,Karnataka 575018 India
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Ruchita Narsia Assistant Professor |
Constituent Colleges from NITTE Deemed to be University |
Department of Physiotherapy, Room no.20, Second Base Division, Nitte Institute of Physiotherapy, NITTE(Deemed to be University) Deralakatte, Mangaluru, Karnataka-575018 India
Dakshina Kannada
KARNATAKA |
9408956388
ruchita.narsia@nitte.edu.in |
| Nain Dos Santos Gomes |
Constituent Colleges from NITTE Deemed to be University |
Department of Physiotherapy,Room no.20, Second Base Division, Nitte Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru,Karnataka-575018 India
Dakshina Kannada
KARNATAKA |
8552991324
naingomes68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non Medical Female Faculties |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group- Base line activity and education on perimenopause |
The participants will receive an educational pamphlet
regarding perimenopause and will be asked to include base line activity of 10
minutes brisk walking daily. Participants will have a diary which will help them
monitor their walking daily.
Pre and post study evaluation will be done using menopause specific quality of life questionnaire and health and work questionnaire.
|
| Intervention |
Experimental Group- Integrated box breathing and flexibility training along with base line activity and education on perimenopause. |
Non medical female faculties from constituent colleges of NITTE
deemed to be university, Mangaluru will be screened based on STRAW guidelines to quantify whether they fall under the phase of perimenopause. Informed consent will be taken from the participants who meet the inclusion criteria. A data collection sheet will be prepared that will contain demographic details and a questionnaire which will be used to evaluate the knowledge
and perception of perimenopause. Pre study evaluation will be done using menopause specific
quality of life questionnaire and health and work questionnaire.
EXPERIMENTAL GROUP: participants will receive an educational pamphlet
on perimenopause. Integrated box breathing and flexibility training will be taught to the participants. Treatment protocol for box breathing
based on FITT
principle : 20 rounds each twice daily for 4 weeks for 5 minutes of treatment duration. Participants will also follow a structured flexibility regime: 2-4 repset
(7sets) per day for 3 days a week for a period of 4 weeks. The stretch will be
pulled to the point of tightness, held for 30 seconds each for 10-15 minutes per
session. The exercise protocol will consist of 14 stretches Part A- 1) Triceps stretch,
2) Latissmus dorsi stretch, 3)standing quadriceps stretch, 4) short adductor
stretch
5) trunk muscle stretch
6) back extensor stretch
7) abdominal flexor
stretch.
Part B- 1) trunk muscle stretch
2) quadriceps stretch
3) Adductor stretch
4) Seated triceps stretch
5) Lattismus dorsi stretch
6) Back extensor stretch
7) prone quadriceps stretch.
Stretches in Part A will be performed on 1st and 3rd week of the intervention while part B will be performed on 2nd and 4th week of the intervention program.
Post study evaluation will be done using menopause specific quality of life questionnaire and health and work questionnaire.
The exercise intervention will be conducted in a well ventilated room with
adequate light as a group therapy along with the therapist for 3 days/week for
4 weeks. The participants will then be asked to follow the exercise protocol at
home, for better result.
Additionally, participants will engage in a baseline activity of 10 minutes brisk
walking daily. Participants will maintain a diary which will help them monitor
their exercise.
The treatment will be for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Women aged 35-55 years
2)Non- medical female faculties from NITTE deemed to university
3)Women fluent in English speaking
4)Who are willing to participate in the given study
5)Those who experience at least 1 of the perimenopausal symptoms mentioned
in the questionnaire
6)Sedentary individuals
7)Stage- 2 of STRAW guidelines: variable cycle with length changes of 7+days
from normal cycle
8)Stage-1 of STRAW guidelines: 2 or more missed cycles one lasting more than
60+ days
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1)Post- menopausal women
2)Women who are diagnosed with other medical conditions
3)Women undergoing any alternate therapy to overcome these symptoms
4)Those who have practiced box breathing before
5) Chronic menstrual irregularity
6) Abnormal uterine (eg-fibroids) and ovarian (eg-endometrioma) anatomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menopause Specific Quality of Life and Health and Work Questionnaire. |
Menopause Specific Quality of Life and Health and Work Questionnaire, are the primary outcomes that will be assessed at baseline and at 4 weeks that is after the completion of the intervention. The pre and post scores will be then evaluated. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Data collection sheet-demographic details, menstrual history, anthropometric measurements & knowledge & perception on perception.
2)STRAW guidelines- To quantify phase of perimenopause. |
The study will commence by using STRAW guidelines to quantify the female participants followed by collection of data through data collection sheet. Secondary outcome measures will be used at the baseline of the study. It will be used only once. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
10/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Mid-life marks a pivotal phase for women, characterized by significant physical, biological, social, and emotional changes, including perimenopause—a transition towards menopause. In India, women typically reach menopause around 47.5 years, with perimenopause starting at 42.6 years, earlier than in industrialized nations. Hormonal changes during this period can cause symptoms like hot flashes, fatigue, and mood swings, impacting quality of life and work performance. In many countries including India, there is indeed a lack of awareness and knowledge about perimenopause and related health issues that women may experience in this stage of life . The gap in information can have a significant impact on woman’s well-being. The study targets the working population which may be beneficial to industrial health . Globally, more women are entering the workforce, but there is a shortage of studies examining their quality of life, health and job performance. Box breathing is a contemporary technique used as a coping mechanism, yet there is an uncharted territory when it comes to exploring its use in improving quality of life and performance among perimenopausal women. Similarly there is limited knowledge about the benefits of light intensity exercises such as stretching among the same. |