| CTRI Number |
CTRI/2024/04/065940 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
The Effect of Strength Training on Nerve testing, fatigue and cognition in Hypothyroidism patients |
|
Scientific Title of Study
|
The Effect of Strength Training on Nerve Conduction Velocity, Fatigue and Cognition in Hypothyroidism |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhi Pandey |
| Designation |
Research Scholar |
| Affiliation |
Manav Rachna International Institue of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Department of physiotherapy division - Q Block Neurology lab room no. QG 07
Surajkund Road Faridabad
Haryana
121004
India
Faridabad
HARYANA
121004
India |
| Phone |
7836871009 |
| Fax |
|
| Email |
shubhipandey@555gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita kumari |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institue of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy Department division - Q block room no. QG-07 Sector-43 Aravalli hills surajkund Road Faridabad, haryana, 121004 India
Faridabad
HARYANA
121004
India |
| Phone |
8800125047 |
| Fax |
|
| Email |
sunita.fas@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita kumari |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institue of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy Department division -Q block room no. QG07
surajkund Road Faridabad
Haryana
121004
India
Faridabad
HARYANA
121004
India |
| Phone |
8800125047 |
| Fax |
|
| Email |
sunita.fas@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institue of Research and Studies manav rachna campus road, Gadakhor basti Village, Sector-43 Fariabad, haryana pincode-121004 India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Sunita kumari |
Manav Rachna International Institute of Research and Studies |
Department of physiotherapy Division Q block neurology lab room no. QG 07 Manav Rachna International Institute of Research and studies sector 43 Aravalli Hills Surajkund road Faridabad, Harayana 121004 India
Faridabad
HARYANA |
8800125047
sunita.fas@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Department of Allied Health Science, Manav Rachna International Institute of research and Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E018||Other iodine-deficiency related thyroid disorders and allied conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Strength Training |
After pre assessment session I would be performing Strength Training session. It would be of a 6 week protocol which will include 18 session (3 times per week). The duration of each session would be of 50 minute including:
10 min warm up
30 min strength training
10 min cool down period including 3sets and 6repetitions per set
Intensity 1 RM progressed at own rate. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Age group between 18 to 30 years old with diagnosed cases of hypothyroidism more than 2 years old and also on medication for hypothyroidism |
|
| ExclusionCriteria |
| Details |
Smokers, Asthmatic, Diabetic, Any cardiovascular complications, Individuals having other neuropathy, Individuals with skin lesion, Subject who will not give consent, Any neuromuscular disorder, Diagnosed cases of Dementia/depression |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nerve Conduction studies to measure motor and sensory nerve conduction velocity amplitude and latency, Fatigue severity scale for fatigue and MoCA for cognition |
pre interventional assessment and post interventional assessment will be taken of the outcome measure between the time period of 2 weeks |
|
|
Secondary Outcome
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/04/2024 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim of the study is to find the effect of strength training on nerve conduction velocity, fatigue and cognition in hypothyroid patients. Hypothyroidism is the commonest endocrinal disorder. It is clear from many studies that decreased nerve conduction velocities, fatigue and impairment in cognition is seen in hypothyroidism, and if resides it may lead to peripheral neuropathy, compression syndrome; fatigue and cognition may hamper activity of daily living. So it is important to take a chance to resolve it by providing strength training to the hypothyroid individuals. Strength training helps - to gain the overall strength, to improve fatigue resistance, to improve cognition. |