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High-Intensity Interval Exercise in Bronchiectasis Patients

3 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

42

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Keçiören
      • Ankara, Keçiören, Turquía (Türkiye), 06018
        • Reclutamiento
        • Gulhane Faculty of Physiotherapy and Rehabilitation
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Intervention
Patients in this group will perform airway clearance techniques along with high-intensity interval exercise.
Otro: 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.
Otro: 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.
Comparador activo: Control
Patients in this group will only undergo airway clearance techniques.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Performance
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximal Inspiratory Pressure (PImax)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Saglik Bilimleri Universitesi

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

27 de marzo de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

29 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Publicado por primera vez (Actual)

4 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026-085

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Due to patient confidentiality, data will not be shared.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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