Endurance Training in Patients With Post-TB Lung Disease

Effect of Endurance Training On Functional Capacity and Quality of Life 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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Post-Tuberculous Pleural Fibrosis; Post-Tuberculous Bronchiectasis
• Intervention / Treatment: Other: Experimental; Other: Control

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25000
      • Green Star NGO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Aerobic and respiratory endurance exercises with patient education	Other: Experimental; 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
Placebo Comparator: Control; Usual care (Patient Education, Home Plan)	Other: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Mehwish Waseem, MSPT-CPPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Endurance training; Functional Capacity; Post-TB lung disease
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bronchial Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Bronchiectasis; Lung Diseases; Tuberculosis
• Other Study ID Numbers: Rec/01657 Safa Marwa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No