Clinical trial NCT05881538: High Intensity Intervallic Training in Children With Bronchiolitis Obliterans
Official title: Effectiveness of a High-intensity Intervallic Training Program in Children and Adolescents With Post-infectious Bronchiolitis Obliterans: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis Obliterans
Keywords: High intensity interval training
Post-infectious bronchiolitis obliterans
Telematic program
Cardiorespiratory fitness
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Consejo Superior de Deportes, Spain
First posted: 2023-05-31
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.
Primary purpose: TREATMENT

Brief summary: Post-Infectious Bronchiolitis Obliterans (PIBO) is an irreversible obstructive lung disease characterized by subepithelial inflammation and fibrotic narrowing of the bronchioles after lower respiratory tract infection. This disease is diagnosed mainly in children, more frequently before the age of 2 years. Due to symptoms such as dry cough and dyspnea sensation, most of these patients have low levels of physical activity compared to healthy individuals. Physical activity can positively influence oxygen consumption, muscle strength, and quality of life. High levels of oxygen consumption are associated with a lower risk of respiratory disease and hospitalization. High-intensity interval training (HIIT) may be an effective way to improve oxygen consumption, muscle strength, and quality of life in patients with chronic diseases. HIIT has been shown to produce less dyspnea sensation and to be more entertaining in children and adolescents with respiratory disease compared to continuous training. Thus, the investigators propose to perform telematically real-time guided training to reduce travel times and additional costs to patients.

Objective: To analyze the effects of a telematically supervised high-intensity intervallic training program on aerobic fitness, as well as functional/clinical outcomes in patients with PIBO.

Methods: Randomized controlled trial with two groups. Exercise group: 16-week HIIT training conducted telematically; Control group: will follow the routine physician's recommendations. Patients will be recruited at Vall D'Hebrón University Hospital (Barcelona), Niño Jesús University Hospital (Madrid), and Donostia Universitary Hospital (San Sebastián). Criteria for participation: (I) Diagnosis of PIBO; (II) Clinically stable at the time of the assessments; (III) Age between 6 to 20 years old.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Postinfectious bronchiolitis obliterans;
* Clinical stability at the time of the assessments;
* Age between 6 and 20 years old.

Exclusion Criteria:

* Symptoms of pulmonary exacerbation during the last four weeks;
* Diagnosis of other cardiorespiratory diseases leading to symptoms of persistent respiratory dysfunction;
* Difficulty in comprehension or musculoskeletal alterations that may influence the assessments;
* Pregnancy;
* Transplant list inclusion.

Primary outcomes:
measure: Change in peak oxygen consumption
timeFrame: Change from baseline to 16 weeks
measure: Change in time to ventilatory threshold
timeFrame: Change from baseline to 16 weeks
measure: Change in percent oxygen consumption at ventilatory threshold
timeFrame: Change from baseline to 16 weeks
measure: Change in ventilatory efficiency
timeFrame: Change from baseline to 16 weeks
Secondary outcomes:
measure: Change in forced expiratory volume in the first second
timeFrame: Change from baseline to 16 weeks
measure: Change in forced vital capacity
timeFrame: Change from baseline to 16 weeks
measure: Change in forced expiratory flow between 25 and 75% of forced vital capacity
timeFrame: Change from baseline to 16 weeks
measure: Change in muscle strength
timeFrame: Change from baseline to 16 weeks
measure: Change in lower body strength
timeFrame: Change from baseline to 16 weeks
measure: Change in free fat mass
timeFrame: Change from baseline to 16 weeks
measure: Change in lean mass
timeFrame: Change from baseline to 16 weeks
measure: Change in hip-waist ratio
timeFrame: Change from baseline to 16 weeks
measure: Change in body mass index
timeFrame: Change from baseline to 16 weeks
measure: Change in quality of life
timeFrame: Change from baseline to 16 weeks
measure: Change in dyspnea
timeFrame: Change from baseline to 16 weeks
Other outcomes:
measure: Height in meters
timeFrame: Change from baseline to 16 weeks
measure: Weight in kilograms
timeFrame: Change from baseline to 16 weeks
measure: Daily physical activity level
timeFrame: Change from baseline to 16 weeks
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Catalunya
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: País Vasco
city: Madrid
country: Spain
facility: Hospital Universitario Infantil Niño Jesús
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Márcio VF Donadio, PhD
role: PRINCIPAL_INVESTIGATOR
References: