Respiratory Muscle Stretching Exercise for Improving Quality of Life of Patients With Bronchiectasis

NCT ID: NCT06722547

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2025-01-27

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.

Conditions

Bronchiectasis Post-Tuberculosis Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (Standard Pulmonary Rehabilitation)

Aerobic exercise, PLB, ACBT, Education

Group Type: ACTIVE_COMPARATOR

Standard PR

Intervention Type: OTHER

PLB, ACBT, Aerobic exercise, Education

Group B (Standard PR + RMS)

Standard PR plus Respiratory Muscle Stretching

Group Type: EXPERIMENTAL

Standard PR plus Respiratory Muscle Stretching

Intervention Type: OTHER

Standard PR plus Respiratory Muscle Stretching (RMS)

Interventions

Standard PR

PLB, ACBT, Aerobic exercise, Education

Intervention Type: OTHER

Standard PR plus Respiratory Muscle Stretching

Standard PR plus Respiratory Muscle Stretching (RMS)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dian Marta Sari, MD., M.Sc., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

Dr. M. Goenawan Partowidigdo Lung Hospital

Bogor, West Java, Indonesia

Countries

Indonesia

References

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.

Reference Type: BACKGROUND

PMID: 33401266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12243314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33959177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32381002 (View on PubMed)

Other Identifiers

IKFR-202411.04

Identifier Type: -

Identifier Source: org_study_id