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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI169588-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Arm Intervention | Experimental | 8 weeks (short arm) of a pulmonary rehabilitation (PR) program |
|
| Long Arm Intervention | Experimental | 24 weeks (extended arm) of a pulmonary rehabilitation (PR) program |
|
| Standard of care | No Intervention | Standard TB treatment without specific pulmonary rehabilitation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8 week (short arm) Intervention - pulmonary rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Six-Minute Walk Test (6MWT) distance (meters) | Mean distance compared between study arms | 48 weeks post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk test (6MWT) distance (meters) | Mean 6MWT distance compared between study arms at 8,16 & 24 weeks after enrollment. | 8,16 & 24 weeks post enrollment |
| Absolute percent change in Mean Six minute walk test (6MWT) distance |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4, 8,12, 16, 20, 24, & 48 weeks post enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akshay Gupte, PhD MBBS MSPH | Contact | 617-358-2454 | agupte1@bu.edu | |
| Jonathan Golub, PhD MPH | Contact | 443-287-2969 | jgolub@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Akshay Gupte, PhD MBBS MSPH | Boston University | Principal Investigator |
| Jonathan Golub, PhD MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yenepoya (Deemed to be University | Recruiting | Mangalore | India |
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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.
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| 24 week (long arm) Intervention - pulmonary rehabilitation | Behavioral | 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. |
|
Difference between study arms in the absolute and percent change in mean 6MWT distance
| 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 | 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. | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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. | 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 | 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. | 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 | 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. | 24 & 48 weeks post enrollment |
| Absolute change in FEV1 volume (mL) - Lung function | Difference between study arms in the absolute change in FEV1 volume | 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. | 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 | 8, 16, 24 & 48 weeks post enrollment |
| FVC volume (mL) - Lung function | FVC volume (mL) compared between study arms | 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 | 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 | 8,16, 24 & 48 weeks post enrollment |
| Symbiosis Medical College for Women & Symbiosis University Hospital and Research Center | Recruiting | Pune | India |
|
| ID | Term |
|---|---|
| D055985 | Latent Tuberculosis |
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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