Endurance Training in Patients With Post-TB Lung Disease

Study Overview
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Brief Summary
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To determine the effects of endurance training on functional capacity and QOL(Quality of life) in patients with post-TB (tuberculosis) lung disease. Post-tuberculosis lung disease is a major health concern nowadays. There is limited evidence in the literature regarding the rehabilitation of patients with cured tuberculosis which leads to post-TB complications.

Detailed Description
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Adults with post-TB respiratory symptoms experience skeletal muscle weakness due to inactivity, systemic inflammation, and poor nutrition, which is frequently made worse by poverty. Such patients experience a vicious cycle that includes decreased body weight, increasing morbidity, and higher mortality. People with Chronic Respiratory Diseases frequently avoid exercise, which causes them to lose motivation and decondition. This cycle of decline continues. In Pakistan, there is no concept of pulmonary rehabilitation for TB patients. The current study will attempt to fill this literature gap and also promote the concept of pulmonary rehabilitation for post-tuberculosis patients in Pakistan.

Official Title
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Effect of Endurance Training On Functional Capacity and Quality of Life in Patients With Post-TB Lung Disease

Conditions
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Tuberculosis, Post-Tuberculous Pleural Fibrosis, Post-Tuberculous Bronchiectasis

Intervention / Treatment
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* Other: Experimental
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TB (diagnosed) with Completed TB course Dyspnea (with or without cough) Age (18-50yrs). After 3 months of AFB and gene expert (-) Decreased PFT predicted values Exclusion Criteria: Smoker, Diabetes, and cardiac patients Physical disabled, pregnant (lactating women) Sputum + testing for TB Gene expert CVD (unstable) Not willing to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional<br>Aerobic and respiratory endurance exercises with patient education | Other: Experimental<br>* Cycling 2 days per week with Borg dyspnea 4-6 level for 15-20 minutes/ day with 5 minutes warm-up and cool-down. Strengthening exercises for upper limb muscles (pull-ups and biceps curls) and for lower limb muscles (sit-to-stand and step-up exercises) with 3 sets of 8-12 repetitions * 2 days per week. Pursed Lip breathing exercise 3 sets of 5-10 repetitions for 6 weeks<br>|
| Placebo Comparator: Control<br>Usual care (Patient Education, Home Plan) | Other: Control<br>* Usual care: frontal chest radiographs, verbal advice to quit smoking, and reduce exposure to biomass smoke. Spirometry to screen for airway diseases. Antibiotic and systemic glucocorticoid therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through 6 min walk test (6 MWT). It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support. | 3 weeks, 6 weeks | 
| Dyspnea | Changes from baseline to 3 weeks and 6 weeks after the intervention, measured through the BORG dyspnea scale. it uses a scale from 0 to 10, where 0 represents no dyspnea and 10 represents maximal dyspnea. | 3 weeks, 6 weeks | 
| Forced Expiratory Volume in 1 second (FEV1) | Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters | 3 weeks,6 weeks | 
| Forced vital Capacity (FVC) | Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters | 3 weeks,6 weeks | 
| Peak Expiratory Flow (PEF) | Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second. | 3 weeks,6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endurance training, Functional Capacity, Post-TB lung disease, Quality of Life