Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)

N/ANot Yet RecruitingNCT07164742

Johns Hopkins University690 enrolled

Overview

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: 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

690

Conditions

TB - Tuberculosis TB TB Infection

Interventions

8 week (short arm) Intervention - pulmonary rehabilitationBEHAVIORAL

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 week (long arm) Intervention - pulmonary rehabilitationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Six-Minute Walk Test (6MWT) distance (meters)

Mean distance compared between study arms

Time frame: 48 weeks post enrollment

Secondary Outcomes

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

Central Contacts

Akshay Gupte, PhD MBBS MSPH

CONTACT

617-358-2454 agupte1@bu.edu

Jonathan Golub, PhD MPH

CONTACT

443-287-2969 jgolub@jhmi.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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