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High-Intensity Interval Exercise in Bronchiectasis Patients

3 września 2026 zaktualizowane przez: Saglik Bilimleri Universitesi

Investigation of the Effectiveness of High-Intensity Interval Exercise in Bronchiectasis Patients

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

42

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Turcja (Türkiye)
    • Keçiören
      • Ankara, Keçiören, Turcja (Türkiye), 06018
        • Rekrutacyjny
        • Gulhane Faculty of Physiotherapy and Rehabilitation
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Intervention
Patients in this group will perform airway clearance techniques along with high-intensity interval exercise.
Inny: high-intensity interval exercise
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.
Inny: Airway 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.
Aktywny komparator: Control
Patients in this group will only undergo airway clearance techniques.
Inny: Airway 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Functional Performance
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Maximal Inspiratory Pressure (PImax)
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study.
Maximal Expiratory Pressure (PEmax)
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study.
Forced Vital Capacity (FVC)
Ramy czasowe: 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).
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study.
FEV1 (Forced Expiratory Volume in 1 Second)
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study.
FEV1/FVC
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study
Fatigue
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study
Dyspnea Severity
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study.
The Bronchiectasis Health Questionnaire
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study
Cough Questionnaire
Ramy czasowe: 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.
At the beginning of the study, after 8 weeks of treatment, and at week 4 following the study.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Saglik Bilimleri Universitesi

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

27 marca 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2026

Ukończenie studiów (Szacowany)

29 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

21 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 września 2026

Pierwszy wysłany (Rzeczywisty)

4 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 września 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2026-085

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Due to patient confidentiality, data will not be shared.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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