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Completed

NCT Number: NCT06047795

Endurance Training in Patients With Post-TB Lung Disease

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Post-Tuberculous Bronchiectasis Post-Tuberculous Pleural Fibrosis

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Green Star NGO

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental

Other

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

Control

Other

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.

Primary outcomes

  1. Functional capacity

    Time frame: 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.

  2. Dyspnea

    Time frame: 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.

  3. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 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

  4. Forced vital Capacity (FVC)

    Time frame: 3 weeks,6 weeks

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

  5. Peak Expiratory Flow (PEF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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