Endurance Training in Patients With Post-TB Lung Disease

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047795
• Other study ID #: Rec/01657 Safa Marwa
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: Mehwish Waseem, MSPT-CPPT
• Phone: 0331-5309015
• Email: mehwish.waseem[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Lung Diseases
• Tuberculosis

Intervention

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
• 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.

Locations

Country	Name	City	State
Pakistan	Green Star NGO	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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