| CTRI Number |
CTRI/2017/11/010595 [Registered on: 22/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
whether respiratory muscle strengthening improves the overall physical capacity in persons with paraplegia |
|
Scientific Title of Study
|
Effect of inspiratory muscle training on aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Soumyashree |
| Designation |
Research Scholar |
| Affiliation |
Indian Spinal Injuries Centre-Institute of rehab Sciences |
| Address |
research scholar, Indian spinal Injuries Centre- Institute of rehabilitation Sciences,2nd floor, New Delhi
South
DELHI
110070
India |
| Phone |
9582182439 |
| Fax |
|
| Email |
sonalisoumyashree0309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaskirat Kaur Guide |
| Designation |
Associare proffessor |
| Affiliation |
Indian Spinal Injuries Centre-Institute of rehab Sciences |
| Address |
ISIC-Institute of rehabilitation Sciences, newdelhi
South
DELHI
110070
India |
| Phone |
9891264977 |
| Fax |
|
| Email |
drjaskirat2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Soumyashree |
| Designation |
Research Scholar |
| Affiliation |
Indian Spinal Injuries Centre-Institute of rehab Sciences |
| Address |
isic-irs, 2nd floor, sector c, vasant kunj, new delhi
South
DELHI
110070
India |
| Phone |
9582182439 |
| Fax |
|
| Email |
sonalisoumyashree0309@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian SpinalInjuries Centre- Institute of rehab Sciences, 2nd floor, new delhi |
|
|
Primary Sponsor
|
| Name |
Sonali Soumyashree |
| Address |
D8 , Vasant Kunj, New Delhi |
| Type of Sponsor |
Other [selfsponser] |
|
|
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 |
| Sonali Soumyashree |
Indian Spinal Injuries Centre |
ISIC-Institute of rehab sciences, 2nd floor, Sector C, Vasant Kunj,New Delhi
South
DELHI |
9582182439
sonalisoumyashree0309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe,ISIC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of inspiratory muscle training on aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics |
Inspiratory muscle training using threshold IMT device to improve aerobic capacity |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with paraplegia from traumatic or non-traumatic cause
Duration of injury- ≥ 3 months
Level of injury- T1- T12
Age-18 years - 65 years
AIS-A, B and C
Ability to propel a manual wheelchair in the community
Subjects who were alert and medically stable
|
|
| ExclusionCriteria |
| Details |
Subjects taking medication that could affect heart rate e.g. Beta blockers, Ca++ channel blocker
Subjects with pre morbid respiratory condition like asthma, COPD, restrictive lung diseases
Subjects who are current smokers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 12 minute Wheel chair aerobic fitness test, Six minute Push Test, Multistage fitness test |
at baseline and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maximum inspiratory pressure, Maximum expiratory Pressure, Modified Borg Scale |
At baseline and after 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2016 |
| Date of Study Completion (India) |
03/04/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Journal of Spinal cord medicine |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A sample of 30
subjects, who met the inclusion and exclusion criteria, are recruited from the
rehabilitation department of Indian Spinal Injuries Centre, New Delhi. A
written informed consent is obtained from the subjects. Demographic data is
taken and detailed neurological examination is done. The subjects are then
randomly allocated into following two groups by computer generated random
number table Group 1 (Experimental
group) was given inspiratory muscle training. Group 2 (Control
group) was given deep breathing exercise training. Both the groups
continued their regular training program throughout the study. Intervention was
given for 15 minutes, 5 days a week for 4weeks. Pre and post
intervention values of 12 minute wheelchair aerobic test, six minute push test, multistage fitness test , MIP, MEP were measured and scores on
MBS are obtained.
|