Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
8 week (short arm) Intervention - pulmonary rehabilitation
Behavioral8 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 week (long arm) Intervention - pulmonary rehabilitation
Behavioral24 weeks (extended arm) of a pulmonary rehabilitation (PR) program, administered during TB treatment, comprising of exercise training, counselling and education, and airway clearance techniques.
Treatment groups
690 Participants
are divided into 3 treatment groupsGroup A: Short Arm InterventionExperimental treatment 1 intervention
Group B: Long Arm InterventionExperimental treatment 1 intervention
Group C: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Six-Minute Walk Test (6MWT) distance (meters)
Mean distance compared between study arms
Time frame
48 weeks post enrollmentSecondary outcomes
1
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 enrollment2
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 enrollment3
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 enrollment4
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 enrollmentOther outcomes
1
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 enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov