| CTRI Number |
CTRI/2025/10/096365 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effects of Calisthenics based training and Aerobic exercises on Thyroid profile , Lipid profile and body measurements in patients with Subclinical Hypothyroidism. |
|
Scientific Title of Study
|
Effect of Calisthenics-based training and Aerobic Exercises on Thyroid profile ,Lipid profile and Anthropometric measurements in patients with Subclinical Hypothyroidism -A Randomized control 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 |
Soumya Hulamani |
| Designation |
Assistant professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre , Room no. 39, Department of Orthopedic Physiotherapy ,Sagar Floor , KLE Dr. Prabhakar Kore hospital and Medical Research Centre , Belgaum,
Belgaum
KARNATAKA
590010
India |
| Phone |
7483414279 |
| Fax |
|
| Email |
soumyahulamani@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Hulamani |
| Designation |
Assistant professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre , Room no. 39, Department of Orthopedic Physiotherapy ,Sagar Floor , KLE Dr. Prabhakar Kore hospital and Medical Research Centre , Belgaum,
Belgaum
KARNATAKA
590010
India |
| Phone |
7483414279 |
| Fax |
|
| Email |
soumyahulamani@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Netra Avadhani |
| Designation |
intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre , Room no. 39, Department of Orthopedic Physiotherapy ,Sagar Floor , KLE Dr. Prabhakar Kore hospital and Medical Research Centre , Belgaum,
Belgaum
KARNATAKA
590010
India |
| Phone |
8197369153 |
| Fax |
|
| Email |
netra4j@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Centre , Room no. 39,Department of Orthopedic Physiotherapy , Sagar floor , KLE Dr. Prabhakar Kore Hospital and Medical Research Centre , Belagavi, Karnataka ,590010 |
| 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 |
| RESEARCH AND ETHICAL COMMITTEE KAHER INSTITUTE OF PHYSIOTHERAPY |
KAHER Institute of Physiotherapy |
Advanced Physiotherapy Centre, Room no. 39, Department of Orthopedic Physiotherapy , Sagar Floor , KLE Dr. Prabhakar Kore Hospital and Medical Research Centre , Belagavi Karnataka , 590010
Belgaum
KARNATAKA |
08312473906
principalkipt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E348||Other specified endocrine disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aerobic exercises |
the subjects are given a protocol designed to improve thyroid profile
EXCERCISES :- mobility, stretvhes,jogging, marching, stepside, highknee, half squat, shadow boxing , buttkicks
total duration 30 minutes |
| Comparator Agent |
calisthenic based training |
calisthenic based training protocol:- stepping, lunging, jumping, squats, bending toe touch, wall pushups
total duration 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects willing to participate in the study
2)Adults of all genders aged 20-40years
3)diagnosed with subclinical hypothyroidism confirmed with elevated TSH and normal levels of T3 and T4 levels of by an endocrinologist |
|
| ExclusionCriteria |
| Details |
1)subjects with cardiovascular disease (eg. heart failure ,recent myocardial infarction, uncontrolled hypertension)
2)Musculoskeletal or neurological condition limiting exercise participation
3)subjects who are already on any exercise program |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Thyroid profile (serum TSH,T4 and T3 levels)
Lipid profile
Anthropometric parameters(waist hip ratio, Abdominal girth) |
Thyroid profile (serum TSH,T4 and T3 levels)
Lipid profile
to be assessed before intervention is given
Anthropometric parameters(waist hip ratio, Abdominal girth)
the assessment will be done pre and post intervention (4 weeks)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
This study is a randomized clinical trial evaluating how calisthenics-based training and aerobic exercise affect thyroid profiles, lipid profiles, and anthropometric measurements in patients with subclinical hypothyroidism. The research aims to determine if structured exercise interventions can improve hormone levels, lipid profile, and anthropometric measurements compared to standard care. Participants between ages 20-40 diagnosed with subclinical hypothyroidism are randomly assigned to exercise regimens focused on calisthenics or aerobic activities over six months. The trial is designed to fill a knowledge gap on non-pharmacologic, evidence-based physiotherapy management for patients with subclinical hypothyroidism, with the ultimate goal of guiding future rehabilitation protocols and improving patient outcomes. |