| CTRI Number |
CTRI/2019/04/018357 [Registered on: 01/04/2019] Trial Registered Prospectively |
| Last Modified On: |
25/03/2019 |
| 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
|
skeletal muscle exercise impact on outcome of post tubercular obstructive airway disease |
|
Scientific Title of Study
|
Pulmonary rehabilitation in post tubercular obstructive airway disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabir Kumar Prusti |
| Designation |
Post Graduate Trainee |
| Affiliation |
VIMSAR Burla |
| Address |
Department of Pulmonary Medicine VIMSAR Burla
Sambalpur
ORISSA
768017
India |
| Phone |
8457821911 |
| Fax |
|
| Email |
prusti.prabir16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUDARSHAN POTHAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
VIMSAR Burla |
| Address |
Department of Pulmonary Medicine VIMSAR Burla
Sambalpur
ORISSA
768017
India |
| Phone |
9437238992 |
| Fax |
|
| Email |
pothal2002@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabir Kumar Prusti |
| Designation |
Post Graduate Trainee |
| Affiliation |
VIMSAR Burla |
| Address |
Department of Pulmonary Medicine VIMSAR Burla
ORISSA
768017
India |
| Phone |
8457821911 |
| Fax |
|
| Email |
prusti.prabir16@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PULMONARY MEDICINE,
VIMSAR BURLA
dist-sambalpur-768017 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PULMONARY MEDICINE |
| Address |
department of pulmonary medicine.
VIMSAR ,BURLA |
| Type of Sponsor |
Government medical college |
|
|
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 sudarshan pothal |
vimsar |
department of pulmonary medicine
Sambalpur
ORISSA |
9437238992
pothal2002@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIREC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
pulmonary rehabilitaion |
pulmonary rehabilitaion in post tubercular obstuctive airway disease |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.MORE THAN 18 YEARS
2.Subjects diagnosed with post TB OAD.
3.Willing to come to pulmonary rehabilitation centre at pulmonary medicine department twice a week for 4 weeks. |
|
| ExclusionCriteria |
| Details |
1.ACTIVE TB(MICROBIOLOGICALY CONFIRMED)
2.NON TUBERCULAR COPD
3.AGE<18YRS
4PATIENT IN ACUTE EXACERBATION
5.UNSTABLE CARDIOVASCULAR DISEASE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in 6MWT
Change in mMRC dyspnea scale
Change in frequency of exacerbation
Change in frequency of hospitalization
Change in FEV1
Change in quality of life
|
6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in quality of life |
1 year |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
01/04/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
RESEARCH
QUESTION
Does pulmonary rehabilitation improve
the outcome in post TB OAD,as compared to pharmacotherapy alone? OBJECTIVE
To know the outcome of pulmonary function in
post TB OAD patients after pulmonary rehabilitation. Subjects will undergo pulmonary rehabilitation program
twice weekly for 6 weeks, which will include endurance training of upper &
lower limb, strength training of upper and lower limb, stretching exercise and
flexibility exercise & will be overseen by physiotherapist in collaboration
with a counselor. they will also continue pharmacotherapy.Controls will be given
pharmacotherapy alone. After 6 weeks cases will be
encouraged to do exercise at home. That will include endurance training upper
& lower limb, stretching exercise & flexibility exercise along with
pharmacotherapy.
— Change will be seen in the form of 6MWT,mMRC,
standardized questionnaire and will be compared with controls.
— Controls will be called in weekly to
explain importance of medication and to check if the technique of taking
medication is correct or not. Enrollment will be up to 1 year. All patient’s will be followed up
for 6 month in 3 monthly interval to
collect data through structured questionnaire.
Enrolled patients will be reminded about
scheduled follow up date by telephone. |