| CTRI Number |
CTRI/2024/07/071009 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2024 |
| 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
|
A clinical trial to know the impact of regular physical activity on hypothyroidism and well-being among peri and post-menopausal women |
|
Scientific Title of Study
|
Effect of Habitual Physical Activity on Hypothyroidism and Biopsychosocial Parameters among Peri and Post-Menopausal women - A Randomized Controlled Pilot 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 |
Deepshika S P |
| Designation |
Post Graduate Student |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT33 5th floor SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6383450216 |
| Fax |
|
| Email |
ds0120@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT33 5th floor SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room No:PT33 5th floor SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram Tamil Nadu India 603203 |
|
|
Primary Sponsor
|
| Name |
Deepshika S P |
| Address |
Room No:PT33 5th floor SRM College of Physiotherapy SRM Medical College Hospital and Research Centre SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram Tamil Nadu India 603203 |
| 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 M Anbupriya MPT |
SRM Medical College Hospital and Research Center |
SRM Department of General Medicine and SRM Department of Obstetrics and Gynaecology SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur
Kancheepuram
TAMIL NADU |
9841549219
anbuprim@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital And Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E039||Hypothyroidism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habitual Physical Activity |
Patient education, A set of habitual physical activities will be taught. A session will be of 15 minutes performed 5 times a week for 8 weeks. |
| Comparator Agent |
Without performing habitual physical activity |
Patient education and advice on habitual physical activity using visual representation will be given. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Age 40 to 55 years
Peri and Post-menopausal women
Clinically diagnosed case of hypothyroidism and on medications |
|
| ExclusionCriteria |
| Details |
Participants with a history of cardiovascular diseases, back pain, hypertension, diabetes mellitus, current smoking, hepatic or renal disease, acute or chronic infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Levels of T3, T4 and TSH |
Pretest
Post test (after the duration of 8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MenQOL questionnaire |
Pretest
Post test (after the duration of 8 weeks) |
| Habitual physical activity questionnaire (Baecke) |
Pretest
Post test (after the duration of 8 weeks) |
| Pittsburg Sleep Quality Index questionnaire |
Pretest
Post test (after the duration of 8 weeks) |
| Beck Depression Inventory Scale |
Pretest
Post test (after the duration of 8 weeks) |
| International Physical Activity Questionnaire Short form |
Pretest
Post test (after the duration of 8 weeks) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Individuals will be selected for the study based on the inclusion and exclusion criteria. The study will be clearly explained in patient words and an informed consent will be obtained. The subjects will be divided into experimental group(n-30) and control group(n-30). Both the groups will be asked to fill up the MenQOL questionnaire before and after the study. Experimental group will undergo 8 weeks of habitual physical activity programme (5 days per week for 30 minutes, subjects will be asked to continue the exercises other days also) along with their medications. Control group will receive education and will be asked to continue their medications. Thyroid test will be taken after the completion of the 8 weeks training. Test results will be checked for T3, T4 and TSH level changes. |