| CTRI Number |
CTRI/2024/12/077867 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| 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
|
Effect of Jacobsons Relaxation Technique and Pilates on Insomnia and Quality of Life During Perimenopause |
|
Scientific Title of Study
|
Effectiveness of Jacobsons Relaxation Technique and Pilates on Insomnia and Quality of Life During Perimenopause |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANJANA VENKATARAMAN |
| Designation |
PG STUDENT |
| Affiliation |
SAVEETHA COLLEGE OF PHYSIOTHERAPY, SIMATS |
| Address |
Room no. A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu.
Room no.A5,
5th floor,
Health Science block,
Saveetha college of Physiotherapy,
Saveetha nagar,
Thandalam,
Kancheepuram,
Tamil Nadu.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9167514151 |
| Fax |
|
| Email |
sanjvenkat2530@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramana K |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha college of physiotherpay |
| Address |
A5 5th floor
Health Science block
Saveetha college of Physiotherapy
Saveetha nagar
Thandalam
Kancheepuram
Tamil Nadu
A5 5th floor
Health Science block
Saveetha college of Physiotherapy
Saveetha nagar
Thandalam
Kancheepuram
Tamil Nadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8939925505 |
| Fax |
|
| Email |
ramana.scpt@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramana K |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha college of physiotherpay |
| Address |
A5 5th floor
Health Science block
Saveetha college of Physiotherapy
Saveetha nagar
Thandalam
Kancheepuram
Tamil Nadu
A5 5th floor
Health Science block
Saveetha college of Physiotherapy
Saveetha nagar
Thandalam
Kancheepuram
Tamil Nadu
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8939925505 |
| Fax |
|
| Email |
ramana.scpt@saveetha.com |
|
|
Source of Monetary or Material Support
|
| A5 5th floor,Health Science block Saveetha college of Physiotherapy,Saveetha nagar,Thandalam,Kancheepuram,Tamil Nadu 602105. |
|
|
Primary Sponsor
|
| Name |
Sanjana Venkataraman |
| Address |
A5 5th floor,Health Science block Saveetha college of Physiotherapy,Saveetha nagar,Thandalam,Kancheepuram,Tamil Nadu 602105 |
| 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 Ramana K |
Saveetha Hospital |
A5 5th floor,Health Science block Saveetha college of Physiotherapy,Saveetha nagar,Thandalam,Kancheepuram,Tamil Nadu 602501
Kancheepuram
TAMIL NADU |
8939925505
sanjvenkat2530@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL SCIENTIFIC REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perimenopause women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jacobsons relaxation technique |
Opting for a quite and cozy place
Focusing on Breathing
Tensing and relaxing every muscle group
Duration - 6 weeks, 4 sessions per week
Staying focused on the present
|
| Intervention |
Pilates |
Roll up
One leg circle
Spine strtch
The saw
The swan dive
Shoulder bridge with one leg
Shoulder bridge
The swimming pushup
Duration - 6 weeks, 4 sessions per week, 3 sets 10 reps |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
45-55 years old in perimenopause stage
Women in this age group having sleep disturbances |
|
| ExclusionCriteria |
| Details |
Menopausal women who suffered from acute or chronic heart disease
Uncontrolled hypertension
Mental disorders
Diabetes
Women who had undertaken medications for diabetes |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pittsburgh Sleep Quality Index (PSQI)
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Menopause-specific Quality of Life (MENQOL) Questionnaire |
6 weeks |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
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
|
Physical activity would be helpful to promote mind and body relaxation resulting in
improvement of sleep quality. Jacobsons relaxation technique is one such type of
progressive muscular relaxation technique which along with diaphragmatic
breathing focuses to relax each muscle group. On the other hand, Pilates include a
set of exercises which concentrates on improving strength, posture, flexibility, and
mental awareness. According to recent research Pilates has shown to be effective in
improving physical and psychological effects in pre and post-menopausal women.
Based on the effect of exercises as mentioned above, this study focuses to analyse
and compare the effects of Jacobsons relaxation technique and Pilates on insomnia
to improve the quality of life during the menopause transition stages. |