| CTRI Number |
CTRI/2020/12/030000 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To Analyse the Effect of Circuit-Interval Training On dysfunction in understanding the mental process of learning Among Hypothyroidism Patients - An Interventional Study |
|
Scientific Title of Study
|
To Analyse the Effect of Circuit-Interval Training on Cognitive Dysfunction Among Hypothyroidism Patients-An Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VISHWABEN SUTHAR |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy RK UNIVERSITY |
| Address |
School of physiotherapy , RK UNIVERSITY , Kasturbadham , Rajkot-Bhavnagar Highway , Rajkot , Gujarat , India
School pf physiotherapy , RK UNIVERSITY , Kasturbadham , Rajkot-Bhavnagar Highway , Rajkot , Gujarat , India
Rajkot
GUJARAT
360020
India |
| Phone |
8401911025 |
| Fax |
|
| Email |
vsuthar325@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Rakholiya |
| Designation |
Associate professor , school of physiotherapy , RK UNIVERSITY |
| Affiliation |
School of physiotherapy RK UNIVERSITY |
| Address |
School of physiotherapy , RK UNIVERSITY , Lab no 3 school of physiotherapy , RK UNIVERSITY , Kasturbadham , Rajkot-Bhavnagar Highway , Rajkot , Gujarat , India
School of physiotherapy , RK UNIVERSITY , Lab no 3 school of physiotherapy , RK UNIVERSITY , Kasturbadham , Rajkot-Bhavnagar Highway , Rajkot , Gujarat , India
Rajkot
GUJARAT
360020
India |
| Phone |
9724779333 |
| Fax |
|
| Email |
shweta.rakholiya@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
VISHWABEN SUTHAR |
| Designation |
Post graduate student |
| Affiliation |
School of physiotherapy RK UNIVERSITY |
| Address |
School of physiotherapy , RK UNIVERSITY , Kasturbadham , Rajkot-Bhavnagar Highway , Rajkot , Gujarat , India
School of physiotherapy , RK UNIVERSITY , Kasturbadham , Rajkot-Bhavnagar Highway , Rajkot , Gujarat , India
Rajkot
GUJARAT
360020
India |
| Phone |
8401911025 |
| Fax |
|
| Email |
vsuthar325@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of physiotherapy , RK UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
VISHWABEN SUTHAR |
| Address |
School of physiotherapy , RK UNIVERSITY , Kasturbadham , Rajkot-Bhavnagar Highway , Rajkot , Gujarat , India |
| 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 |
| VISHWA SUTHAR |
GMERS civil hospital Gandhinagar |
GMERS medical college & hospital civil hospital campus , near pathikasharam , sector 12 , Gandhinagar ,382012
Gandhinagar
GUJARAT |
8401911025
vsuthar325@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee , School of physiotherapy , RK University , Rajkot - Bhavnagar Highway Tramba Rajkot - 360020 Gujarat India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E038||Other specified hypothyroidism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Circuit-interval training |
Training protocol consist of the following exercise: Squats, Static lunges, Standing leg calf raises ,Back extension, Shoulder bridge , Push-ups ,Crunches , Side-crunches , Step ups , Side to side jumps
Dosage : In week 1&2 : 1 circuit/session,In week 3&4 : 2 circuit/session,In week 5&6 : 3 circuit/session
Repetition of each exercise in week 1,3,5 : 15 repetition
Repetition of each exercise in week 2,4,6 : 20 repetition
Circuit-interval training will be undergo for 3 days/week for 6 weeks.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
TFTs showing TSH>5 mU/L
MMSE score 19 to 23 : Mild cogitive impairment
|
|
| ExclusionCriteria |
| Details |
Patients with neuromuscular disorder and any other associated medical condition
Any pathological condition of spine and bones |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini - mental state examination scale |
1st Day and End of 6th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6 minute walk test |
1st Day and End of 6th week |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/01/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title : To Evaluate The Effect of Circuit-interval Training on Cognitive Dysfunction Among Hypothyroidism Patients : An Interventional Study
Investigator : VISHWA SUTHAR , School of physiotherapy , RK University
Aim : To Evaluate The Effect of Circuit-interval Training on Cognitive Dysfunction Among Hypothyroidism Patients .
Objectives :
- To evaluate effectiveness of circuit-interval training to improve cognition
- To evaluate effectiveness of circuit-interval training to improve endurance
- To compare the correlation between the cognition and endurance
Materials :
Pen , Paper , Assessment form , Consent form , Stop watch , Stethoscope , Sphygmomanometer , Measure tape , Chair
Procedure :
- Subjects Who Fulfill The Inclusion Criteria will be Selected. Consent will be Taken From all The Subjects for Participating in The Study.
- Further They will be Divided in Two Group of 75 Subjects in Each Group A and Group B.
- Pre and Post Intervention Outcome Measures MMSE and 6 Min Walk Test will be Taken.
- Group A will be Undergo Circuit-Interval Training Protocol and Group B will Undergo only Active Medication.
- Treatment Duration will be 3 Day/Week for 6 Week.
|