Endurance Training in Patients With Post-TB Lung Disease

NCT ID: NCT06047795

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2024-06-30

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.

Conditions

Tuberculosis; Post-Tuberculous Pleural Fibrosis; Post-Tuberculous Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional

Aerobic and respiratory endurance exercises with patient education

Group Type: EXPERIMENTAL

Experimental

Intervention Type: 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

Usual care (Patient Education, Home Plan)

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehwish Waseem, MSPT-CPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Green Star NGO

Peshawar, KPK, Pakistan

Countries

Pakistan

Other Identifiers

Rec/01657 Safa Marwa

Identifier Type: -

Identifier Source: org_study_id