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CTRI Number  CTRI/2023/08/056956 [Registered on: 25/08/2023] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial of pulmonary rehabilitation to improve lung health in TB. 
Scientific Title of Study   PULMONARY REHABILITATION TO REDUCE POST-TUBERCULOSIS MORBIDITY (TB PURE)-A RANDOMISED MULTI-CENTRE TRIAL 
Trial Acronym  TB PURE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meenakshi Bhakare 
Designation  Associate Professor In charge HOD Respiratory Medicine 
Affiliation  Symbiosis Medical College for Women 
Address  Respiratory Medicine Department Symbiosis Medical College for Women and SUHRC SIU Gram Lavale Pune Symbiosis Medical College for Women and SUHRC SIU Gram Lavale Pune 412115 Pune MAHARASHTRA
Symbiosis Medical College for Women and SUHRC SIU Gram Lavale Pune Symbiosis Medical College for Women and SUHRC SIU Gram Lavale Pune 412115 Pune MAHARASHTRA
Pune
MAHARASHTRA
412115
India 
Phone  9096555775  
Fax    
Email  meenakshi.bhakare@smcw.siu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Meenakshi Bhakare 
Designation  Assistant Professor In charge HOD Respiratory Medicine 
Affiliation  Symbiosis Medical College for Women 
Address  Respiratory Medicine Department Symbiosis Medical College for Women and SUHRC SIU Gram Lavale Pune Symbiosis Medical College for Women and SUHRC SIU Gram Lavale Pune 412115 Pune MAHARASHTRA


MAHARASHTRA
412115
India 
Phone  9096555775  
Fax    
Email  meenakshi.bhakare@smcw.siu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Vidya Mave 
Designation  Director 
Affiliation  Johns Hopkins India 
Address  Johns Hopkins India G 4 and 5 PHOENIX Building opposite to Residency Club Pune 411001 Maharashtra India
G 4 and 5 PHOENIX Building opposite to Residency Club Pune 411001 Maharashtra India
Pune
MAHARASHTRA
411001
India 
Phone  02026052419  
Fax    
Email  vmave1@jhmi.edu  
 
Source of Monetary or Material Support  
National Institutes of Health (NIH) 
 
Primary Sponsor  
Name  US National Institutes of Health 
Address  National Institutes of Health (NIH) 9000 Rockville Pike Bethesda Maryland 20892 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meenakshi Bhakare  Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center  Respiratory Medicine Department OPD No 8,Building No 3
Pune
MAHARASHTRA 		 9096555775

meenakshi.bhakare@smcw.siu.edu.in 
Dr Poonam Naik  Yenepoya Medical College University  Respiratory Medicine Deaprtment 1st Floor Consultation room number 4
Dakshina Kannada
KARNATAKA 		 7259346643

drpoonamnaik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Independent Ethics Committee of Symbiosis International University  Approved 
Yenepoya Ethics Committee 1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A157||Primary respiratory tuberculosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pulmonary Rehabilitation  Home based PR regime administered for 8 weeks short arm and 24 weeks duration extended PR arm 
Comparator Agent  Standard of care   Standard of care arm no PR administered 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details 
Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease.Participants with just smear microscopy results will be enrolled provisionally to stay within the window of enrollment. Thereafter, if the culture results indicate drug resistance, the participant will be offered the opportunity to participate in follow-up visits, can continue with the intervention, but the data will not be considered in the final analysis.
Not completed more than 2 weeks of TB treatment
Receiving TB care at the outpatient clinics at the TB PuRe study sites
Willingness to complete 48 weeks of study evaluations.
Access to a smartphone.
 
 
ExclusionCriteria 
Details  Modified Medical Research Council score of 0 points (dyspnea only with strenuous exercise)
Multi or extensively drug-resistant TB disease.
Extrapulmonary TB disease at any clinical sites without pulmonary involvement
TB meningitis or TB of the spine
Symptomatic cardiovascular disease, including coronary artery disease, arrhythmias and congestive cardiac failure.
Karnofsky Score < 40 points
Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower/upper limbs/pregnancy
Bronchodilators and/or corticosteroids inhaled or otherwise.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
6MWT
 
Mean distance compared between study arms at 48 weeks after enrollment  
 
Secondary Outcome  
Outcome  TimePoints 
6 Minute walk test  Mean 6MWT distance compared between study arms at 8 16 and 24 weeks after enrollment
Difference between study arms in the absolute and percent change in mean 6MWT distance at 8 16 24 and 48 weeks after enrollment
Difference between study arms in the proportion of participants with an MCID change in the 6MWT distance by 8 16 24 and 48 weeks after enrollment
 
SGRQ mMRC CRQ CAT scores  Total and sub-domain questionnaire scores compared between study arms at 8 16 24 48 weeks after enrollment
Difference between study arms in the absolute and percent change in questionnaire scores 8 16 24 and 48 weeks after enrollment
Difference between study arms in the proportion of participants with an MCID change in questionnaire scores 8 16 24 and 48 weeks after enrollment
 
Lung function
FEV1 and FVC
 		 FEV1 and FVC volume compared between study arms at 24 and 48 weeks after enrollment.
Difference between study arms in the absolute and percent change in FEV1 and FVC volumes by 8 16 24 and 48 weeks after enrollment
Difference between study arms in the proportion of participants with an MCID change in FEV1 and/or FVC 8 16 24 and 48 weeks after enrollment
 
 
Target Sample Size   Total Sample Size="690"
Sample Size from India="690" 
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 
Date of First Enrollment (India)   01/09/2023 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Title:

Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PuRe)

Population:

690 adults with drug-sensitive pulmonary tuberculosis (TB) with impaired functional status at study enrollment

Intervention:

8 weeks (short arm) or 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques

Objectives:

1.       To compare the effectiveness of two home-based PR programs, administered during TB treatment, for preventing post-TB respiratory morbidity.

2.       To describe the intersection between clinic-level service organization, fidelity of intervention delivery, and change in client behavior for the two PR programs.

3.       To compare the costs, cost-effectiveness, and budget impact of the two different PR strategies implemented as a routine program.

Design/Methodology:

Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.

Primary Outcome:

Mean 6-minute walk test distance compared between the three study arms at 48 weeks after enrollment

Total Study Duration:

5 years

Subject Participation Duration:

48 weeks
 
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