An interventional study of 8 week (short arm) Intervention - pulmonary rehabilitation and 24 week (long arm) Intervention - pulmonary rehabilitation in TB - Tuberculosis, TB and TB Infection, sponsored by Johns Hopkins University. Recruiting at 2 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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:
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
This study's planned enrollment of 690 is above the median of 300 across 110 interventional studies indexed under Latent Tuberculosis.
Browse Latent Tuberculosis studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 weeks (short arm) of a pulmonary rehabilitation (PR) program
Behavioral: 8 week (short arm) Intervention - pulmonary rehabilitation
24 weeks (extended arm) of a pulmonary rehabilitation (PR) program
Behavioral: 24 week (long arm) Intervention - pulmonary rehabilitation
Standard TB treatment without specific pulmonary rehabilitation
8 weeks (short arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.
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.
Six-Minute Walk Test (6MWT) distance (meters)
Mean distance compared between study arms
Time frame: 48 weeks post enrollment
Six minute walk test (6MWT) distance (meters)
Mean 6MWT distance compared between study arms at 8,16 \& 24 weeks after enrollment.
Time frame: 8,16 & 24 weeks post enrollment
Absolute percent change in Mean Six minute walk test (6MWT) distance
Difference between study arms in the absolute and percent change in mean 6MWT distance
Time frame: 8,16, 24 & 48 weeks post enrollment
Proportion of Participants with change in Six minute walk test (6MWT) distance (meters)
Difference between study arms in the proportion of participants with an Minimal Clinically Important Difference (MCID) change in the 6MWT distance
Time frame: 8,16, 24 & 48 weeks post enrollment
St. George's Respiratory Questionnaire (SGRQ) score
The questionnaire measures respiratory health quality of life in three areas with a total score ranging from 0-100. A higher score indicates poorer health status.
Time frame: 8,16,24 & 48 weeks post enrollment
Absolute change in score for St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in the absolute change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Percent change in score for St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in the percent change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Proportion of participants with change in score for St. George's Respiratory Questionnaire (SGRQ)
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Modified Medical Research Council (mMRC) Dyspnoea Scale
The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea.
Time frame: 8,16,24 & 48 weeks post enrollment
Absolute change in the Modified Medical Research Council (mMRC) Dyspnoea Scale
Difference between study arms in the absolute change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Percent change in the Modified Medical Research Council (mMRC) Dyspnoea Scale
Difference between study arms in the percent change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Proportion of participants with change in Modified Medical Research Council (mMRC) Dyspnoea Scale
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
The CRQ assesses dyspnea on a Likert scale from 1 (Extremely short of breath) to 7 (Not at all short of breath). Total score ranges from 5 - 35. Lower scores indicate higher severity of dyspnea.
Time frame: 8,16,24 & 48 weeks post enrollment
Absolute change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
Difference between study arms in the absolute change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Percent Change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score
Difference between study arms in the percent change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Proportion of participants with change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea sore
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
COPD Assessment Test (CAT) score
CAT total score range is from 0-40, higher scores indicates a more severe impact of COPD on a patient's life.
Time frame: 8,16,24 & 48 weeks post enrollment
Absolute change in COPD Assessment Test (CAT) score
Difference between study arms in the absolute change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
Percent change in COPD Assessment Test (CAT) score
Difference between study arms in the percent change in questionnaire scores 8,16, 24 \& 48 weeks after enrollment.
Time frame: 8,16,24 & 48 weeks post enrollment
Proportion of participants with a change in COPD Assessment Test (CAT) score
Difference between study arms in the proportion of participants with an MCID change in questionnaire score
Time frame: 8,16,24 & 48 weeks post enrollment
FEV1 volume (mL) - Lung function
FEV1 volume (mL) compared between study arms at 24 \& 48 weeks after enrollment.
Time frame: 24 & 48 weeks post enrollment
Absolute change in FEV1 volume (mL) - Lung function
Difference between study arms in the absolute change in FEV1 volume
Time frame: 8, 16, 24 & 48 weeks post enrollment
Percent change in FEV1 volume (mL) - Lung function
Difference between study arms in the percent change in FEV1 volume by 8,16, 24 \& 48 weeks after enrollment.
Time frame: 8, 16, 24 & 48 weeks post enrollment
Proportion of participants with change in FEV1 and/or FVC volume (mL) - Lung function
Difference between study arms in the proportion of participants with a MCID change in FEV1 and/or FVC
Time frame: 8, 16, 24 & 48 weeks post enrollment
FVC volume (mL) - Lung function
FVC volume (mL) compared between study arms
Time frame: 24 & 48 weeks post enrollment
Absolute change in FVC volume (mL) - Lung function (FEV1 and FVC)
Difference between study arms in the absolute change in FVC volume
Time frame: 8,16, 24 & 48 weeks post enrollment
Percent change in FVC volume (mL) - Lung function (FEV1 and FVC)
Difference between study arms in the percent change in FVC volumes
Time frame: 8,16, 24 & 48 weeks post enrollment
Proportion of participants experiencing unfavorable treatment outcomes (Exploratory Outcome Measure)
Arm comparisons of the proportion of participants experiencing any unfavorable TB treatment outcome of failure, recurrence, or death
Time frame: 4, 8,12, 16, 20, 24, & 48 weeks post enrollment
Plan to share: No
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