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临床试验/NCT06722547
NCT06722547已完成不适用

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

Universitas Padjadjaran1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Functional Exercise Capacity (6-Minute Walk Test)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Group A (Standard Pulmonary Rehabilitation)

Active Comparator

Aerobic exercise, PLB, ACBT, Education

干预措施: Standard PR (Other)

Group B (Standard PR + RMS)

Experimental

Standard PR plus Respiratory Muscle Stretching

干预措施: Standard PR plus Respiratory Muscle Stretching (Other)

结局指标

主要结局

Functional Exercise Capacity (6-Minute Walk Test)

时间窗: 6 weeks

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

次要结局

  • Fatigue (Fatigue Severity Scale)(6 weeks)
  • Quality of Life (St. George's Respiratory Questionnaire)(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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