Endurance Training in Patients With Post-TB Lung Disease

Not Applicable

Recruiting

• Conditions: Tuberculosis; Post-Tuberculous Bronchiectasis; Post-Tuberculous Pleural Fibrosis
• Interventions: Other: Control; Other: Experimental

• Registration Number: NCT06047795
• Lead Sponsor: Riphah International University

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-09-11
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Primary Completion: 2024-06
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Usual care (Patient Education, Home Plan)
Interventional	Experimental	Aerobic and respiratory endurance exercises with patient education

Primary Outcome Measures

Name	Time	Method
Dyspnea	3 weeks, 6 weeks	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.
Forced vital Capacity (FVC)	3 weeks,6 weeks	Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Functional capacity	3 weeks, 6 weeks	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.
Forced Expiratory Volume in 1 second (FEV1)	3 weeks,6 weeks	Changes from the Baseline, the digital spirometer is used in the clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Peak Expiratory Flow (PEF)	3 weeks,6 weeks	Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.

Trial Locations

Locations (1)

Green Star NGO; 🇵🇰 Peshawar, KPK, Pakistan