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High-Intensity Interval Exercise in Bronchiectasis Patients

3. září 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

42

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Intervention
Patients in this group will perform airway clearance techniques along with high-intensity interval exercise.
Jiný: 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.
Jiný: 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.
Aktivní komparátor: Control
Patients in this group will only undergo airway clearance techniques.
Jiný: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functional Performance
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Maximal Inspiratory Pressure (PImax)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Saglik Bilimleri Universitesi

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

27. března 2026

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

29. května 2027

Termíny zápisu do studia

První předloženo

21. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

3. září 2026

První zveřejněno (Aktuální)

4. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. září 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2026-085

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Due to patient confidentiality, data will not be shared.

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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