Bronchiectasis, Non-Cystic Fibrosis, High Intensity Interval Exercise
Conditions
Keywords
Airway clearance techniques, high-intensity interval exercise
Brief summary
The aim of our study is to investigate the effect of high-intensity interval exercise (HIIE) on the symptoms of bronchiectasis in patients with the disease. The main questions it aims to answer are: 1. Does HIIE improve respiratory function in patients with bronchiectasis? 2. Does HIIE increase functional capacity, peripheral muscle strength, and quality of life in patients with bronchiectasis? 3. Does HIIE reduce the severity of dyspnea, cough symptoms, and fatigue in patients with bronchiectasis? The study was designed as a randomized controlled trial. Participants were divided into two groups: intervention and control. Participants will: The intervention group will receive HIIE training three days a week along with airway clearance techniques. The control group would receive only airway clearance techniques. Airway clearance techniques will be provided clinically (three days a week) and at home, according to the needs of the individuals each day of the week.
Interventions
The high-intensity interval exercise (HIIE) protocol (4×4 model: 4 minutes at 85-95% maximum heart rate, with 3 minutes of active recovery at 60-70% in between), will be applied 3 days a week for 8 weeks using a treadmill or cycle ergometer, taking into account the participants' physical characteristics and safety requirements.
OTHERAirway clearance tecniques
Among the airway clearance techniques, the active cycle of breathing techniques (ACBT) and manual techniques will be applied. Additionally, the autogenic drainage technique will be taught to patients for them to practice at home. Airway clearance techniques will be demonstrated to the patients practically and they will be asked to perform them daily (3 days a week in the clinic) as needed.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Being over 18 years of age 2. Having a clinical and radiological diagnosis of non-cystic fibrosis bronchiectasis 3. Absence of cognitive impairment (MMT\>24) 4. Being clinically stable (not having experienced any exacerbation in the last 4 weeks)
Exclusion criteria
1. Presence of any disease that may affect compliance with exercise (Unstable angina (within the last month), recent myocardial infarction (heart attack), uncontrolled arrhythmias, severe aortic stenosis, decompensated heart failure, severe pulmonary hypertension, acute respiratory tract infection, severe hypoxemia at rest (\<85%), orthopedic or neurological problems that impede walking, severe anemia, acute infections, very high resting blood pressure (systolic \>180-200 mmHg, diastolic \>100-110 mmHg), psychological issues, etc.) 2. Smoking 3. Chronic alcoholism that may affect exercise safety (More than 1 drink per day on average for women, more than 2 drinks per day on average for men (1 standard drink ≈ 10-14 g of alcohol) 4. Presence of any respiratory tract disease other than bronchiectasis 5. After incremental shuttle walk test arterial oxygen saturation \<80% 6. Participation in a structured exercise program within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Performance | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study | Functional performance will be measured using an incremental shuttle walk test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Inspiratory Pressure (PImax) | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study. | Inspiratory muscle strength will be assessed by measuring the maximal inspiratory pressure (PImax) using an electronic, portable, intraoral pressure measuring device. PImax represents the maximum negative pressure generated during a forceful inhalation against an occluded airway. Results will be reported in centimeters of water (cmH2O), with higher absolute values indicating greater inspiratory muscle strength. |
| Maximal Expiratory Pressure (PEmax) | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study. | Expiratory muscle strength will be assessed by measuring the maximal expiratory pressure (PEmax) using an electronic, portable, intraoral pressure measuring device. PEmax represents the maximum positive pressure generated during a forceful exhalation against an occluded airway. Results will be reported in centimeters of water (cmH2O), with higher values indicating greater expiratory muscle strength. |
| Forced Vital Capacity (FVC) | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study. | Forced Vital Capacity (FVC) is the total volume of air that can be exhaled forcefully and completely after a maximal inspiration. It is measured using spirometry to assess overall lung volume and capacity. The results will be reported as an absolute volume in Liters (L). |
| FEV1 (Forced Expiratory Volume in 1 Second) | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study. | Forced Expiratory Volume in 1 second (FEV1) is the volume of air forcefully exhaled during the first second after a maximal inspiration, measured using spirometry. Outcomes are reported in absolute volume (Liters) and % to evaluate airway obstruction and overall pulmonary function. |
| FEV1/FVC | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study | FEV1/FVC(%) will be calculated using the FEV1 and FVC values obtained from the pulmonary function test. |
| Fatigue | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study | To assess the severity of fatigue and its impact on daily life, the Fatigue Severity Scale (FSS), a self-report scale, will be used. The scale consists of 9 items, each scored between 1 (strongly disagree) and 7 (strongly agree). The average score is calculated by dividing the total score by the number of items, with higher scores indicating more severe fatigue. A score of 4 or higher generally indicates severe fatigue. |
| Dyspnea Severity | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study. | Dyspnea severity will be assessed using the Modified Medical Research Council dyspnea scale. The scale classifies dyspnea on a five-point scale from 0 to 4; a score of 0 indicates dyspnea occurring only during strenuous exercise, while a score of 4 describes significant shortness of breath even during the mildest daily activities. |
| The Bronchiectasis Health Questionnaire | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study | The Bronchiectasis Health Questionnaire (BHQ) will be used to assess disease-specific quality of life. The BHQ is a patient-completed scale consisting of 10 items that evaluates symptom burden, physical function, and the impact of the disease on daily life. Each item is scored between 0 and 7, and the total score ranges from 0 to 70; higher scores indicate better health status and quality of life. |
| Cough Questionnaire | At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study. | The Leicester Cough Questionnaire (LCQ) is a disease-specific, patient-completed scale developed to assess the impact of cough on quality of life in individuals with chronic cough. The LLC consists of 19 items and covers three sub-dimensions: physical, psychological, and social. Each item is scored between 1 and 7, and the average of the sub-dimension scores is calculated and summed to obtain a total score ranging from 3 to 21; higher scores indicate better quality of life and less cough-related impact. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMustafa Ertuğrul YAŞA, Associate Professor
Outcome results
None listed