| CTRI Number |
CTRI/2026/04/108404 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
14/04/2026 |
| 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
|
Effect of a Multicomponent Exercise Program on Cognitive Function, Balance, Fatigue, and Sleep Quality in Hypothyroid Patients |
|
Scientific Title of Study
|
EFFECT OF MULTIMODAL EXERCISES ON COGNITION, BALANCE, FATIGUE, AND SLEEP QUALITY IN PATIENTS WITH HYPOTHYROIDISM: A RANDOMISED 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 |
Huma Parveen |
| Designation |
Student |
| Affiliation |
Jamia Hamdard |
| Address |
Room no. 9, Rehabilitation centre, Jamia Hamdard, Hamdard Nagar, New Delhi-110062
New Delhi
DELHI
110062
India |
| Phone |
7303699652 |
| Fax |
|
| Email |
rajputhuma957@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Sohrab Ahmed Khan |
| Designation |
Professor and Head |
| Affiliation |
Jamia Hamdard |
| Address |
Department of physiotherapy, Jamia Hamdard, Hamdard Nagar, New Delhi-110062
New Delhi
DELHI
110062
India |
| Phone |
8802648164 |
| Fax |
|
| Email |
sakhan_ahsjamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Huma Parveen |
| Designation |
Student |
| Affiliation |
Jamia Hamdard |
| Address |
Room no. 9, Rehabilitation centre, Jamia Hamdard, Hamdard Nagar, New Delhi-110062
New Delhi
DELHI
110062
India |
| Phone |
7303699652 |
| Fax |
|
| Email |
rajputhuma957@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, School of Allied health sciences and research, Jamia hamdard |
|
|
Primary Sponsor
|
| Name |
Huma Parveen |
| Address |
Jamia Hamdard , Hamdard Nagar, New Delhi-110062 |
| 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 Huma Parveen PT |
Jamia Hamdard |
Room no. 9, rehabilitation centre, Jamia Hamdard, Hamdard Nagar, New Delhi-110062
New Delhi
DELHI |
7303699652
rajputhuma957@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAMIA HAMDARD INSTITUTIONAL ETHICS COMMITTEE NEW DELHI 110062 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Medical conventional treatment |
Participants will continue their routine medical treatment for hypothyroidism without any structured exercise intervention. |
| Intervention |
Multimodal exercises |
multimodal exercises consisting of aerobic, resistance and MCBT
frequency is 3 days per week
Duration is 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Known case of hypothyroidism from at least one year.
2. aged between 30 to 55 years
3. Both male and female
4. BMI between 25 to 30 kg/m2
5. Subjects willing to participate and signed Informed Consent.
6. Patients on 3 months of stable dose of levothyroxine.
7. Subclinical hypothyroidism and controlled hypothyroidism.
8. Stabilised levels of TSH.
|
|
| ExclusionCriteria |
| Details |
1. Recent surgery of spine, lower limb and upper limb (within 6 months)
2. Osteoporosis
3. Malignancy.
4. Secondary hypothyroidism, overt hypothyroidism, pituitary disease, cardiovascular problems such as peripheral vascular disease, arrhythmia or heart failure, diabetes, chronic chest disease.
5. Patients on medication affecting thyroid function such as biotin, musculoskeletal/neurological.
6. Pregnancy & lactating women.
7. Psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue, cognition, balance and sleep quality |
baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/04/2026 |
| 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="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
|
We will collaborate with the Endocrinology department of the hospital to recruit participants diagnosed with hypothyroidism. Eligible participants will be screened based on predefined inclusion and exclusion criteria. Those who meet the criteria and provide informed consent will be randomly assigned to either experimental group or control group. The experimental group will be receiving multimodal exercises for 4 weeks (3 days/week) and control group will be receiving conventional medical treatment. At the end data analysis will be done. The multimodal exercises program will include aerobic, resistance and mindfulness cognitive behavioural therapy. Assessments will be conducted at baseline and 4 weeks using standardized tools to evaluate cognition (MoCA), balance (HUMAC balance), fatigue (FSS) and sleep quality (PSQI). Then data will be analysed using appropriate statistical method. |