| CTRI Number |
CTRI/2020/10/028217 [Registered on: 05/10/2020] Trial Registered Prospectively |
| Last Modified On: |
28/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Pilates exercise on fat reduction and improving quality of life in women with Polycystic Ovarian Syndrome (PCOS). |
|
Scientific Title of Study
|
Effect of Pilates exercise on body composition and quality of life in women with Polycystic Ovarian Syndrome (PCOS) – a randomised control trial. |
| Trial Acronym |
PCOS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Semira Hussaini |
| Designation |
Physiotherapist in department of Community Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of physiotherapy
11/12 Thube Park
Shivajinagar
Pune.
Sancheti Institute College of physiotherapy
Thube Park
Shivajinagar
Pune - 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9730991204 |
| Fax |
|
| Email |
semirahussaini95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Semira Hussaini |
| Designation |
Physiotherapist in department of Community Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of physiotherapy
11/12 Thube Park
Shivajinagar
Pune.
Sancheti Institute College of physiotherapy
Thube Park
Shivajinagar
Pune - 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9730991204 |
| Fax |
|
| Email |
semirahussaini95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suroshree Mitra |
| Designation |
Associate Professor in department of Community Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of physiotherapy
11/12 Thube Park
Shivajinagar
Pune.
Sancheti Institute College of physiotherapy
Thube Park
Shivajinagar
Pune - 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
8087715596 |
| Fax |
|
| Email |
drsurmitra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy
Thube Park
Shivajinagar
Pune- 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 Semira Hussaini |
Sancheti College of Physiotherapy |
Community Department,
Thube park,
Shivajinagar
Pune
MAHARASHTRA |
9730991204
semirahussaini95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Sancheti Institute for orthopedics and rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic exercise and lifestyle modification pamphlet |
60 minutes/session,
3 days/week for 8 weeks,
online follow up once a week |
| Intervention |
Pilates exercise and lifestyle modification pamphlet
|
60 minutes/session,
3 days/week for 8 weeks,
online supervision
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
- Women diagnosed with PCOS as per Rotterdam Criteria.
- Age group- 18 to 25 years.
- Not involved in any other form of physical activity.
- Access to online platform
|
|
| ExclusionCriteria |
| Details |
- Endocrine disorders like Cushing’s syndrome, nonclassical congenital adrenal hyperplasia, and hyperprolactinemia) or renal/hepatic dysfunction.
- Any known case of cardio-vascular and pulmonary disease and anyone with orthopaedic limitation that would hamper their ability to complete a full body Pilates training program
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Waist Circumference |
pre and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body Mass Index |
pre and post intervention |
| Total weight |
pre and post intervention |
| Body Fat Percentage |
pre and post intervention |
| Muscle mass |
pre and post intervention |
| Visceral fat |
pre and post intervention |
| PCOSQ (PCOS Quality of life questionnaire) |
pre and post intervention |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a randomised, single blinded, active control, parallel group trial that studies the effects of Pilates exercise on body composition and quality of life in women with Polycystic Ovarian Syndrome (PCOS). The intervention group received Pilates exercise intervention for 60 minutes per session, 3 times per week for 8 weeks along with a lifestyle modification pamphlet. The control group performed aerobic exercises for 60 minutes per session, 3 times per week for 8 weeks based on the recommendations received in the lifestyle modification pamphlet. The outcome measures i.e., Bioelectrical impedance analysis, waist circumference and quality of life were assessed before and after 8 weeks of intervention. The results showed that Pilates was effective in reducing total body weight, waist circumference, body fat percent, BMI and visceral fat in women with PCOS while it also improved all domains of quality of life (P ≤ 0.05) thus concluding that Pilates exercise is an effective method in improving body composition and quality of life in women with PCOS. |