| CTRI Number |
CTRI/2024/05/066627 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Pilates exercise and Otago exercise program to improve balance, strength in post-Menopausal women |
|
Scientific Title of Study
|
Effect of Pilates exercise v/s Otago Exercise Program to Improve Balance, Strength in Post-Menopausal Elderly Women to Study Fear of Fall and Quality of Life: 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 |
Nikita Zanwar |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute |
| Address |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University), Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370536123 |
| Fax |
|
| Email |
nikitazanwar1811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Lashkari |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute |
| Address |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University), Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422865300 |
| Fax |
|
| Email |
drravilashkari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Lashkari |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute |
| Address |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be University), Sawangi(Meghe) Wardha
MAHARASHTRA
442001
India |
| Phone |
9422865300 |
| Fax |
|
| Email |
drravilashkari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research,(Deemed to be University)sawangi(Meghe),Wardha 442107, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Ravi Nair College of Physiotherapy |
| Address |
Department of Community Health Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research,(Deemed to be University)sawani(Meghe),Wardha 442001 |
| 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 |
| Dr Nikita Zanwar |
Acharya Vinoba Bhave Rural Hospital and Community Physiotherapy OPD |
Department of community health physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(Deemed to be university)
Wardha
MAHARASHTRA |
9370536123
nikitazanwar1811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIHER Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postmenopausal elderly women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Otago exercise program |
March
Head Movements
Neck movements
Back extension
Trunk movements
Ankle movements
Front knee strengthening
Back knee strengthening
Side hip strengthening
Calf raises
Toe raises
Knee bends supported
Knee bends no support
Toe walking supported
Toe walking no support
Heel toe stand supported
Heel toe stand no support
Heel toe walking supported
Heel toe walking no support
One leg stand supported
One leg stand no support
Sideways walking supported
Sideways walking no support
Heel walking supported
Heel walking no supported
Sit to stand using hands
Sit to stand no hands
Backwards walking supported
Backwards walking no support
Heel toe walking backwards
Walk and turn
Stair walking
Ending session
Calf stretch
Back of thigh stretch
|
| Intervention |
Pilates |
duration of 6 weeks, three times per week for around 30 min per session |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1.Women, aged 60 year or older
2.Ability to participate in physical activities
3.Not fallen in the past year
|
|
| ExclusionCriteria |
| Details |
1.Subjects with chronic health conditions, such as ischemic heart disease.
2.Fracture
3.Unable to ambulate independently
4.Those who had problems with their visual, auditory, neural, or vestibular systems.
5.Those who did not understand the content of the experiment
6.Patient having any traumatic Injury to the lower limb.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Balance-Berg Balance Scale (BBS)
2.fear of fall-Fall Efficacy scale
3.strength-30sec sit to stand
4.Older People’s Quality of Life Questionnaire (OPQOL-35)
|
base line 1st week
time line 8th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.strength-30sec sit to stand
2.Older People’s Quality of Life Questionnaire (OPQOL-35) |
base line 1st week
time line 8th week |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
22/05/2024 |
| 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="1"
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
|
The study aims describe the effect of Otago Exercise Program and Pilates exercise with conventional exercise for improving strength, balance and quality of life in postmenopausal elderly women. |