| CTRI Number |
CTRI/2024/08/072451 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| 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
|
To investigate the impact of exercise adherence techniques on participants in order to find out whether they stick with the given exercise and whether there is any improvement in the symptoms of polycystic ovarian syndrome by providing them with a home based exercise program. |
|
Scientific Title of Study
|
Effect of Exercise adherence strategies on the Outcomes of Home-based exercise program for Polycystic Ovary Syndrome: 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 |
Chaithra R |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13 Paediatric Physiotherapy Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad KARNATAKA 580009 India
Dharwad
KARNATAKA
580009
India |
| Phone |
7057454919 |
| Fax |
|
| Email |
chaithragoa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chaithra R |
| Designation |
Postgraduate student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13 Paediatric Physiotherapy Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad KARNATAKA 580009 India
Dharwad
KARNATAKA
580009
India |
| Phone |
7057454919 |
| Fax |
|
| Email |
chaithragoa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Bhatbolan |
| Designation |
Associate professor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD number 13 Paediatric Physiotherapy Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad KARNATAKA 580009 India
Dharwad
KARNATAKA
580009
India |
| Phone |
9916067268 |
| Fax |
|
| Email |
shweta.bhatbolan@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM College of physiotherapy Manjushree Nagar Sattur Dharwad Karnataka India 580009 |
|
|
Primary Sponsor
|
| Name |
Chaithra R |
| Address |
SDM College of medical sciences and hospital SDM College of physiotherapy Manjushree nagar Sattur Dharwad Karnataka India 580009 |
| 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 Chaithra R |
Shri Dharmasthala Manjunatheshwara hospital |
OBG Physiotherapy Department OPD number 13 Manjushree Nagar Sattur Dharwad Karnataka India 580009
Dharwad
KARNATAKA |
7057454919
chaithragoa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - SDM College of Medical Sciences and Hospital |
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 |
PCOS exercise prescription |
Exercise prescription will be designed as per the FITT’s principle and will be customized as per participant’s evaluation.
Exercise will be given 5 to 7 days per week for 30 to 60 minutes per day.
|
| Intervention |
PCOS exercise prescription along with exercise adherence strategy |
Exercise prescription will be designed as per the FITT’s principle and will be customized as per participant’s evaluation along with exercise adherence strategy intervention. Exercise will be given 5 to 7 days per week for 30 to 60 minutes per day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Women diagnosed with PCOS by a
certified medical practitioner
2. Age of participants: 18 years to 35
years
3. Participants who are willing to give
written informed consent |
|
| ExclusionCriteria |
| Details |
1. Participants with any other medical
condition which contradicts them
from participating in physical
activity.
2. Participants who are pregnant
3. Participants undergoing IVF
treatment
4. Psychiatric disorder
5. Uncooperative participants
6. Participants who are not willing to
participate.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exercise adherence calendar |
Exercise adherence calendar will be given to the participants to regularly fill it (everyday for 3 months) which will be collected back at the end of the
study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regularity of menstrual cycle |
It will be taken during the initial assessment and after 3 months (post intervention). |
| The Modified Ferriman-Gallwey (Mfg) Score |
It will be taken during the initial assessment and after 3 months (post intervention). |
| KARADA scan |
It will be taken during the initial assessment and after 3 months (post intervention). |
| Waist hip ratio |
It will be taken during the initial assessment and after 3 months (post intervention). |
| Blood reports - FSH, LH, Prolactin, Testosterone, TSH, Glucose fasting, Glucose post prandial |
It will be taken during the initial assessment and after 3 months (post intervention). |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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 Applicable |
| 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
|
Polycystic ovary syndrome (PCOS) is a common endocrine condition that affects many women
and presents with a range of symptoms and consequences. Lifestyle modification is emphasized as the main early therapeutic strategy in the management
of PCOS as mentioned in “The International Evidence-Based Guideline for the assessment and
management of PCOS†published in the year 2023. Though lifestyle management reportedly has many benefits and is a cost-effective method, the
adherence to lifestyle management (exercise and diet) is found to be low in both diseased and
non-diseased population. So, this study is focusing on impact of exercise adherence strategies to improve the adherence
levels (i.e. overcoming barriers) and facilitate adherence to exercise interventions in women with
PCOS. This study identifies and tests the possible strategies to combat barriers to exercise
participation and adherence. Patients referred to OBG physiotherapy department from
obstetrics and gynaecology department of SDM college of medical
sciences and hospital, Dharwad and Alternately those directly
consulting the OBG physiotherapy department, SDM college of
medical sciences and hospital, Dharwad will be screened for
inclusion and exclusion criteria. Patients who fulfil the criteria
will be provided with the requisite details about the study
procedure. Patients who are willing to participate and have given
consent for the same will be recruited for the study. The
participants signed consent will be obtained and a copy of the
information sheet will be shared. Study procedure will be
explained to the participants. The details of the participants will be
documented. Randomization and allocation will be done using
SNOSE method and participants will be assigned to experimental
and control group accordingly. The assessment of the participants
will be done and findings will be recorded. The participants will
be given intervention and called for follow up for every 15 days
for a period of three months and re-assessment and progression to
exercises will be done and their compliance calendar will be
checked and number of sessions completed will be recorded.
Required support will be provided to continue the programme.
After 3 months post intervention assessment will be done and
findings will be recorded. Data so collected will be analysed
statistically. |