| CTRI Number |
CTRI/2024/02/062833 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effect of mat pilates vs core stability exercises in post menopausal women |
|
Scientific Title of Study
|
A comparative study on the effect of mat Pilates exercise and core stabilization exercises on improving standing balance in overweight postmenopausal females. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sapna Kumari |
| Designation |
student |
| Affiliation |
Indian spinal injuries centre IRS |
| Address |
Indian spinal injuries centre, neurophysiotherapy lab, 1st floor, opp vasant valley school, IAA colony, vasant kunj
South West
DELHI
110070
India |
| Phone |
7703803259 |
| Fax |
|
| Email |
sapnakumari1508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shefali Walia |
| Designation |
Professor |
| Affiliation |
Indian spinal injuries centre IRS |
| Address |
Indian spinal injuries centre, 1st floor, opp vasant valley school, IAA colony, vasant kunj
South West
DELHI
110070
India |
| Phone |
9891770151 |
| Fax |
|
| Email |
shef0604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Kumari |
| Designation |
student |
| Affiliation |
Indian spinal injuries centre IRS |
| Address |
Indian spinal injuries centre, neuro-physiotherapy lab, 1st floor, opp vasant valley school, IAA colony, vasant kunj
South West
DELHI
110070
India |
| Phone |
7703803259 |
| Fax |
|
| Email |
sapnakumari1508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support- Indian Spinal Injuries Centre. |
|
|
Primary Sponsor
|
| Name |
Indian Spinal Injury Centre |
| Address |
Indian spinal injuries centre, neurophysiotherapy lab, 1st floor, opp vasant valley school, IAA colony, vasant kunj |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Sapna Kumari |
Indian Spinal Injury Centre |
Indian spinal injuries centre, neurophysiotherapy lab, 1st floor, opp vasant valley school, IAA colony, vasant kunj
South West
DELHI |
7703803259
sapnakumari1508@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 |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core Stabilization Exercises |
Core stabilization exercise-Core stabilization exercises are exercises that strengthen and stabilizes your abdominal, back, pelvic and hip muscles.
The exercises will be done for 6 weeks (3 sessions per week).
each exercise will be repeated 10 to 15 times for 2 to 5 sets with 10 seconds rest per repetition and 60 seconds rest between the sets.
Rate of perceived exertion will be used to gradually increase the program intensity. |
| Intervention |
Mat Pilates |
Mat Pilates exercise- In Mat Pilates, you will be trained to do slow, precise and sustained series of exercises of trunk, arm and leg muscles along with breath control.
The exercises will be done for 6 weeks (3 sessions per week).
each exercise will be repeated 10 to 15 times for 2 to 5 sets with 10 seconds rest per repetition and 60 seconds rest between the sets.
Rate of perceived exertion will be used to gradually increase the program intensity.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women who are postmenopausal (amenorrhea for at least twelve months).
Women with BMI greater than twentyfive.
Those who are not indulged in any kind of intense structured physical activities or exercise program for six months.
Abdominal muscles strength more than or equal to fair. |
|
| ExclusionCriteria |
| Details |
Women taking hormone replacement therapies within past six months.
Uncontrolled diabetes and hypertension.
 Any recent surgery or trauma.
Cognitive impairments and neurological disorders.
Women having complains of musculoskeletal, neurological problems, pulmonary disorders and cardiac problems that would contradict physical activity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini Best Test
|
6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional reach test |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
28/02/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Postmenopausal females are more likely to be overweight and obese as a result of hormonal alternation. Nearly two-thirds of women aged 40 to 59 years and about three-fourths of women 60 years and older are overweight with BMI>25. Higher BMI in these women usually leads to balance impairment and fall related injuries. Core Stabilization Exercises focuses on core muscles strengthening and stability thus, focused on a particular body part whereas Mat Pilates Exercises tends to focus on principles of breathing, alignment and flowing movement connecting the whole body. This research is to compare the effect of Mat Pilates Exercises and Core Stabilization Exercises on improving standing balance in overweight postmenopausal females. Patients will be selected based on inclusion and exclusion criteria. They will be divided into 2 groups with the help of randomisation method. One group will receive Mat Pilates for 45 mins a day, 3 times a week for 6 weeks. The second group which is a control group will receive Core Stabilization Exercises. The outcome measurements will be done by MiniBEST Test and Functional Reach Test. The changes in outcome measures of both the group post intervention will help us to fine out which intervention is more effective.
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