Clinical trial NCT06722547: Respiratory Muscle Stretching Exercise for Improving Quality of Life of Patients With Bronchiectasis
Official title: The Effects of Addition Respiratory Muscle Stretching Exercise for Improving Functional Exercise Capacity Fatigue and Quality of Life in Patients With Bronchiectasis Post-Tuberculosis Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis Post-Tuberculosis Lung Disease
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bronchiectasis is a chronic condition often arising after the successful treatment of lung tuberculosis, leading to diminished functional exercise capacity, increased fatigue, and reduced quality of life. This randomized controlled trial aims to evaluate the efficacy of adding Respiratory Muscle Stretching (RMS) exercises to standard pulmonary rehabilitation in improving functional exercise capacity, reducing fatigue, and enhancing the quality of life in patients with bronchiectasis post-tuberculosis.

Detailed description: Bronchiectasis, a long-term sequelae of lung tuberculosis, is characterized by permanent dilation and damage of the bronchi, resulting in reduced lung function, persistent fatigue, and significantly impaired quality of life. Standard pulmonary rehabilitation (PR) programs, which include aerobic exercises and breathing techniques like Pursed Lip Breathing (PLB) and the Active Cycle of Breathing Technique (ACBT), are known to offer symptomatic relief and functional improvements. However, the role of Respiratory Muscle Stretching (RMS) in this context has not been well explored.

This clinical trial will assess the impact of RMS, when combined with standard PR, on key outcomes including functional exercise capacity, fatigue, and overall quality of life in patients with bronchiectasis following tuberculosis treatment. The study will involve a parallel assignment of patients to either the standard PR group or the PR plus RMS group, with outcomes measured over a 6-week intervention period. The primary endpoints will include changes in 6-Minute Walk Test (6MWT) distances, Fatigue Severity Scale (FSS) scores, and Quality of Life (St. George's Respiratory Questionnaire) scores.

Eligibility criteria: Inclusion Criteria:

* Age 18-59 years
* History of lung TB treatment
* Clinical or radiological diagnosis of bronchiectasis
* mMRC Dyspnea Scale grade 1-3

Exclusion Criteria:

* Pneumothorax Pleural effusion
* Neuromuscular disease
* Lung malignancy
* history of COVID-19

Primary outcomes:
measure: Functional Exercise Capacity (6-Minute Walk Test)
timeFrame: 6 weeks
Secondary outcomes:
measure: Fatigue (Fatigue Severity Scale)
timeFrame: 6 weeks
measure: Quality of Life (St. George's Respiratory Questionnaire)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bogor
country: Indonesia
facility: Dr. M. Goenawan Partowidigdo Lung Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Dian Marta Sari, MD., M.Sc., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allwood BW, Byrne A, Meghji J, Rachow A, van der Zalm MM, Schoch OD. Post-Tuberculosis Lung Disease: Clinical Review of an Under-Recognised Global Challenge. Respiration. 2021;100(8):751-763. doi: 10.1159/000512531. Epub 2021 Jan 5.
citation: O'Leary CJ, Wilson CB, Hansell DM, Cole PJ, Wilson R, Jones PW. Relationship between psychological well-being and lung health status in patients with bronchiectasis. Respir Med. 2002 Sep;96(9):686-92. doi: 10.1053/rmed.2002.1330.
citation: Sami R, Zohal M, Mohammadi N. Clinical Determinants of the Six-Minute Walk Test (6MWT) in Stable Non-Cystic Fibrosis Bronchiectasis Patients. Tanaffos. 2020 Dec;19(4):385-391.
citation: Khosa C, Bhatt N, Massango I, Azam K, Saathoff E, Bakuli A, Riess F, Ivanova O, Hoelscher M, Rachow A. Development of chronic lung impairment in Mozambican TB patients and associated risks. BMC Pulm Med. 2020 May 7;20(1):127. doi: 10.1186/s12890-020-1167-1.