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

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis Post-Tuberculosis Lung Disease
• Intervention / Treatment: Other: Standard PR; Other: Standard PR plus Respiratory Muscle Stretching

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bogor, West Java, Indonesia, 16750
      • Dr. M. Goenawan Partowidigdo Lung Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Standard Pulmonary Rehabilitation); Aerobic exercise, PLB, ACBT, Education	Other: Standard PR; PLB, ACBT, Aerobic exercise, Education
Experimental: Group B (Standard PR + RMS); Standard PR plus Respiratory Muscle Stretching	Other: Standard PR plus Respiratory Muscle Stretching; Standard PR plus Respiratory Muscle Stretching (RMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Exercise Capacity (6-Minute Walk Test)	The 6-Minute Walk Test (6MWT) is a simple, objective, and widely used assessment tool to evaluate an individual's functional exercise capacity. It measures the total distance a person can walk in six minutes on a flat, hard surface at their own pace, serving as an indicator of aerobic capacity and endurance. This test is particularly useful in patients with chronic respiratory or cardiovascular conditions as it reflects their ability to perform daily physical activities. Prior to the test, baseline measurements of blood pressure, heart rate, oxygen saturation, and dyspnea (using the Borg Dyspnea Scale) are recorded. During the test, participants are encouraged with standardized verbal prompts while allowed to rest if needed. The primary outcome is the total distance walked, with additional observations such as pauses, walking speed, and symptoms documented. The 6MWT easy to administer, and provides valuable insights into a patient's functional status, treatment efficacy, and prognosis	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue (Fatigue Severity Scale)	Fatigue, a common symptom in chronic conditions, is characterized by a subjective sense of physical and mental exhaustion that can interfere with daily functioning. The Fatigue Severity Scale (FSS) is a validated self-reported questionnaire designed to assess the impact of fatigue on a person's ability to perform routine activities. Comprising nine items, the FSS measures the severity of fatigue experienced over the past week, with responses ranging from 1 (strong disagreement) to 7 (strong agreement). A higher mean score indicates greater fatigue severity. The FSS is widely used in clinical and research settings for its reliability and ability to distinguish fatigue levels in patients with various conditions, including respiratory diseases, neurological disorders, and autoimmune diseases. It provides valuable insights into the extent of fatigue, helping guide interventions and monitor treatment outcomes.	6 weeks
Quality of Life (St. George's Respiratory Questionnaire)	The St. George's Respiratory Questionnaire (SGRQ) is a validated self-administered tool designed to assess health-related quality of life in patients with respiratory diseases. It consists of 50 items divided into three domains: Symptoms (frequency and severity of respiratory symptoms), Activity (activities limited by breathlessness), and Impacts (effects of the disease on daily life, including emotional aspects). Each domain and the total score range from 0 to 100, with higher scores indicating poorer health-related quality of life. The SGRQ provides a comprehensive evaluation of a patient's perception of their respiratory health, making it a valuable instrument for clinical trials, disease monitoring, and evaluating treatment outcomes. It has been translated into various languages, including Indonesian, ensuring reliability and validity across diverse populations.	6 weeks

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Principal Investigator: Dian Marta Sari, MD., M.Sc., Ph.D, Faculty of Medicine Universitas Padjadjaran Bandung

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): January 27, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bronchial Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Lung Diseases; Tuberculosis; Bronchiectasis
• Other Study ID Numbers: IKFR-202411.04

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