Gulhane Faculty of Physiotherapy and Rehabilitation
Ankara, Keçiören, 06018, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07805174
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ankara, Keçiören, 06018, Turkey (Türkiye)
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Saglik Bilimleri Universitesi
Other
Investigation of the Effectiveness of High-Intensity Interval Exercise in Bronchiectasis Patients
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