TB, TB Infection, TB - Tuberculosis
Conditions
Keywords
pulmonary tuberculosis, Pulmonary Rehabilitation, post-tuberculosis respiratory morbidity, Drug-sensitive TB
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORAL8 week (short arm) Intervention - 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.
BEHAVIORAL24 week (long arm) Intervention - pulmonary rehabilitation
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.
Sponsors
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at least 18 years * Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease\* * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-Minute Walk Test (6MWT) distance (meters) | 48 weeks post enrollment | Mean distance compared between study arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk test (6MWT) distance (meters) | 8,16 & 24 weeks post enrollment | Mean 6MWT distance compared between study arms at 8,16 \& 24 weeks after enrollment. |
| Absolute percent change in Mean Six minute walk test (6MWT) distance | 8,16, 24 & 48 weeks post enrollment | Difference between study arms in the absolute and percent change in mean 6MWT distance |
| Proportion of Participants with change in Six minute walk test (6MWT) distance (meters) | 8,16, 24 & 48 weeks post enrollment | Difference between study arms in the proportion of participants with an Minimal Clinically Important Difference (MCID) change in the 6MWT distance |
| St. George's Respiratory Questionnaire (SGRQ) score | 8,16,24 & 48 weeks post enrollment | 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. |
| Absolute change in score for St. George's Respiratory Questionnaire (SGRQ) | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the absolute change in questionnaire score |
| Percent change in score for St. George's Respiratory Questionnaire (SGRQ) | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the percent change in questionnaire score |
| Proportion of participants with change in score for St. George's Respiratory Questionnaire (SGRQ) | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the proportion of participants with an MCID change in questionnaire score |
| Modified Medical Research Council (mMRC) Dyspnoea Scale | 8,16,24 & 48 weeks post enrollment | The Modified Medical Research Council Dyspnea Scale scores range from 0 (minimum) to 4 (maximum), with higher scores indicating more severe dyspnea. |
| Absolute change in the Modified Medical Research Council (mMRC) Dyspnoea Scale | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the absolute change in questionnaire score |
| Percent change in the Modified Medical Research Council (mMRC) Dyspnoea Scale | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the percent change in questionnaire score |
| Proportion of participants with change in Modified Medical Research Council (mMRC) Dyspnoea Scale | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the proportion of participants with an MCID change in questionnaire score |
| Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score | 8,16,24 & 48 weeks post enrollment | 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. |
| Absolute change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the absolute change in questionnaire score |
| Percent Change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea score | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the percent change in questionnaire score |
| Proportion of participants with change in Chronic Respiratory Disease Questionnaire (CRQ) Dyspnea sore | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the proportion of participants with an MCID change in questionnaire score |
| COPD Assessment Test (CAT) score | 8,16,24 & 48 weeks post enrollment | CAT total score range is from 0-40, higher scores indicates a more severe impact of COPD on a patient's life. |
| Absolute change in COPD Assessment Test (CAT) score | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the absolute change in questionnaire score |
| Percent change in COPD Assessment Test (CAT) score | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the percent change in questionnaire scores 8,16, 24 \& 48 weeks after enrollment. |
| Proportion of participants with a change in COPD Assessment Test (CAT) score | 8,16,24 & 48 weeks post enrollment | Difference between study arms in the proportion of participants with an MCID change in questionnaire score |
| FEV1 volume (mL) - Lung function | 24 & 48 weeks post enrollment | FEV1 volume (mL) compared between study arms at 24 \& 48 weeks after enrollment. |
| Absolute change in FEV1 volume (mL) - Lung function | 8, 16, 24 & 48 weeks post enrollment | Difference between study arms in the absolute change in FEV1 volume |
| Percent change in FEV1 volume (mL) - Lung function | 8, 16, 24 & 48 weeks post enrollment | Difference between study arms in the percent change in FEV1 volume by 8,16, 24 \& 48 weeks after enrollment. |
| Proportion of participants with change in FEV1 and/or FVC volume (mL) - Lung function | 8, 16, 24 & 48 weeks post enrollment | Difference between study arms in the proportion of participants with a MCID change in FEV1 and/or FVC |
| FVC volume (mL) - Lung function | 24 & 48 weeks post enrollment | FVC volume (mL) compared between study arms |
| Absolute change in FVC volume (mL) - Lung function (FEV1 and FVC) | 8,16, 24 & 48 weeks post enrollment | Difference between study arms in the absolute change in FVC volume |
| Percent change in FVC volume (mL) - Lung function (FEV1 and FVC) | 8,16, 24 & 48 weeks post enrollment | Difference between study arms in the percent change in FVC volumes |
Countries
India
Contacts
CONTACTAkshay Gupte, PhD MBBS MSPH
CONTACTJonathan Golub, PhD MPH
PRINCIPAL_INVESTIGATORAkshay Gupte, PhD MBBS MSPH
Boston University
PRINCIPAL_INVESTIGATORJonathan Golub, PhD MPH
Johns Hopkins University
Outcome results
None listed