| CTRI Number |
CTRI/2024/08/072397 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Exercise] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exercise Testing in muscle groups following 24h Dry Supine Immersion |
|
Scientific Title of Study
|
To Study the changes in Isometric and Isokinetic strength of various muscle groups following 24 hrs of Dry Supine Immersion and evaluate efficacy of a Standarized Exercise Protocol |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savina Oommen George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Microgravity Simulation Lab
Dept Of Space & Environment Physiology.
HAL Old Airport Road, Vimanapura Post, Bengaluru- 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9870550508 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savina Oommen George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Microgravity Simulation Lab
Department Of Space & Environment Physiology
HAL Old Airport Road, Vimanapura Post, Bengaluru- 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9870550508 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savina Oommen George |
| Designation |
Associate Professor |
| Affiliation |
Institute of Aerospace Medicine |
| Address |
Microgravity Simulation Lab
Department Of Space & Environment Physiology
HAL Old Airport Road, Vimanapura Post, Bengaluru- 560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9870550508 |
| Fax |
|
| Email |
savinaoommen@gmail.com |
|
|
Source of Monetary or Material Support
|
| DGAFMS |
| Institute of Aerospace Medicine, HAL Old Airport Road,
Vimanapura Post, Bengaluru-560017 |
|
|
Primary Sponsor
|
| Name |
DGAFMS DRDO |
| Address |
O/o DGAFMS
Ministry of Defence
Delhi- 110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Oommen Savina George Savina O George |
Dept of Space & Environment Physiology |
Institute of Aerospace Medicine
HAL Old Airport Road, Vimanapura Post, Bengaluru- 560017
Bangalore
KARNATAKA |
9870550508
savinaoommen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InsInstitute of Aerospace Medicine IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
20-40 y Males only |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise 3 times a week for 8 weeks duration |
Standardised Exercise Protocol |
| Comparator Agent |
NA |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Healthy Normal Volunteers |
|
| ExclusionCriteria |
| Details |
ECG Abnormality
PFT Abnormality
Acute Illness
Musculoskeletal Abnormality or disability |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To examine the changes in muscle strength |
Exercise for 3 times a week for 8 weeks duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Back Pain |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2024 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Title: To study the changes in isometric and isokinetic
strength of various muscle groups following 24 hrs of Dry Supine Immersion and
evaluate efficacy of a standardized exercise protocol. Aim: To
study the changes in isometric and isokinetic strength of various muscle groups
following 24 hrs of Dry Supine Immersion (DSI) and evaluate efficacy of a
Standardized Exercise Protocol. (b) Objectives: (i) To measure the study the isometric
and isokinetic strength of various muscle groups pre and post 24-h exposure to
simulated microgravity conditions through Dry Supine Immersion. (ii) To study the Electromyography (EMG) of
back muscles during exposure to 24-h Dry Supine Immersion.
(iii) To assess the changes in muscle
strength and EMG following DSI and efficacy of a Standardized Exercise
Protocol. Dry Supine Immersion (DSI) is a method to simulate microgravity analogue here on earth. These finding could be useful in future space missions. In this Institute at IAM, studies are focussed towards this
|