High-Intensity Interval Exercise in Bronchiectasis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaglik Bilimleri Universitesi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being over 18 years of age
Having a clinical and radiological diagnosis of non-cystic fibrosis bronchiectasis
Absence of cognitive impairment (MMT>24)
Being clinically stable (not having experienced any exacerbation in the last 4 weeks)
Disqualifiers
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.)
Smoking
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)
Presence of any respiratory tract disease other than bronchiectasis
Trial design
Design model
Parallel
Treatments tested in this trial
high-intensity interval exercise
Other interventionThe 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.
Airway clearance tecniques
Other interventionAmong 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 2 interventions
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Functional Performance
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 studySecondary outcomes
1
Maximal Inspiratory Pressure (PImax)
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.2
Maximal Expiratory Pressure (PEmax)
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.3
Forced Vital Capacity (FVC)
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.4
FEV1 (Forced Expiratory Volume in 1 Second)
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.Sponsors and contacts
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Source ClinicalTrials.gov