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CTRI Number  CTRI/2024/02/062383 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Cluster Randomized Trial 
Public Title of Study   Pulmonary rehabilitation in sputum positive TB patients  
Scientific Title of Study   Effect of Pulmonary rehabilitation on the exercise tolerance in sputum positive pulmonary TB patients 
Trial Acronym  TB, PR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Poorana Ganga Devi  
Designation  SCIENTIST D 
Affiliation  ICMR NIRT 
Address  Department of Clinical Research, No.1, Mayor Sathiyamoorthy Road
Chetpet
Chennai
TAMIL NADU
600031
India 
Phone  9487260546  
Fax    
Email  drpooranadevi@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Poorana Ganga Devi  
Designation  SCIENTIST D 
Affiliation  Indian Council of Medical Research National Institute for Research in Tuberculosis 
Address  Department of Clinical Research, No.1, Mayor Sathiyamoorthy Road
Chetpet
Chennai
TAMIL NADU
600031
India 
Phone  9487260546  
Fax    
Email  drpooranadevi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Poorana Ganga Devi  
Designation  SCIENTIST D 
Affiliation  Indian Council of Medical Research National Institute for Research in Tuberculosis 
Address  Department of Clinical Research, No.1, Mayor Sathiyamoorthy Road
Chetpet
Chennai
TAMIL NADU
600031
India 
Phone  9487260546  
Fax    
Email  drpooranadevi@yahoo.co.in  
 
Source of Monetary or Material Support  
ICMR, Ansari Nagar, New Ddelhi 
 
Primary Sponsor  
Name  ICMR INTRAMURAL FUNDING 
Address  ICMR, Ansari Nnagar, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Poorana Ganga Devi  National Institute for Research in Tuberculosis  Department of Clinical Research, No.1, Mayor Sathiyamoorthy road, Chetpet, Chennai-600031
Chennai
TAMIL NADU 		 9487260546

drpooranadevi@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute for Research in Tuberculosis IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL ARM  The participants in the control arm will receive standard of care at NTEP centres 
Intervention  PULMONARY REHABILITATION  In addition to usual care described above, participants in the intervention arm will receive PR. 16-week outpatient program 2 days in a week for 8 weeks in Outpatient department and for 8 weeks at home. 16 weeks inpatient program 8 weeks daily monitored program and 8 weeks at home. -Health education awareness sessions on lung health, verbal advice to quit smoking and reduce exposure to biomass smoke, stress management. -Lower and upper limb strength training and extensor exercises -Respiratory exercises (stretching and relaxing) -Lower limb endurance training (walking exercises) -Healthy food intake- Nutritional counselling on balanced diet -Secretion clearance techniques. -Breathing techniques including Yoga techniques. Exercise intensity during each session is incremental and graded according to symptom tolerance.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.aged ≥18 years,
2.willing and able to provide written informed consent
3.a documented history of smear positive pulmonary TB with treatment initiated at selected NTEP centres with smear negative status during the Intensive Phase
4.A report of Medical Research Council (MRC) dyspnoea grade ≥2
 
 
ExclusionCriteria 
Details  1. Previous episode of TB treatment
2. any skeletal deformity that intervenes with physical exercises.
3. unwilling to participate for any reason 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Primary Outcome:
-A change in walking distance measured by the 6 MWT pre-intervention to post-intervention.
2. Secondary Outcome:
-Measurement of association between lung function impairment and radiological changes
-Proportion of participants with optimal respiratory health status
 		 at baseline and at the end of TB treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome:
-Measurement of association between lung function impairment & radiological changes
-Proportion of participants with optimal respiratory health status
 		 at baseline, at end of TB treatment, at 6 months interval for 2 years 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   14/02/2024 
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="3"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drpooranadevi@yahoo.co.in].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 07-01-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Usual care (control arm)

The participants in the control arm will receive standard of care at NTEP centres. Sputa examination, CXR, spirometry, transition dyspnoea index, 6MWT, and QOL assessment will be done at baseline (at randomisation), at 16 weeks post randomisation, at 6,12 and 18 months post ATT completion.

Pulmonary Rehabilitation (PR) (trial intervention arm)

In addition to usual care described above, participants in the intervention arm will receive PR. PR will consist of a 16-week programme offered to participants, with sessions occurring twice weekly for at least 1 hour- 6 weeks initially in an outpatient basis, 6 weeks later at home followed by two weeks each in outpatient basis and at home or will be done as an intense 8 weeks daily monitored program on admission and 8 weeks program being done at home. At home PR adherence will be ensured over telephonic communication.

16-week outpatient program

2 days in a week for 8 weeks in Outpatient department and for 8 weeks at home.

 

16 weeks inpatient program

8 weeks daily monitored program and 8 weeks at home.

 

·         Health education awareness sessions on lung health, verbal advice to quit smoking and reduce exposure to biomass smoke, stress management.

  • Lower and upper limb strength training and extensor exercises
  • Respiratory exercises (stretching and relaxing)
  • Lower limb endurance training (walking exercises)
  • Healthy food intake- Nutritional counselling on balanced diet
  • Secretion clearance techniques.
  • Breathing techniques including Yoga techniques.

Exercise intensity during each session is incremental and graded according to symptom tolerance.

 
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