Bronchiolitis Obliterans
Conditions
Keywords
High intensity interval training, Post-infectious bronchiolitis obliterans, Telematic program, Cardiorespiratory fitness
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.
Interventions
OTHERExercise group
Participants will perform a 16-week High Intensity Interval Training exercise program, twice a week. The intervention will be conducted telematically with real time supervision.
Sponsors
Consejo Superior de Deportes, Spain
Universitat Internacional de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The evaluators and care providers will be masked to the allocation of the patients. Given the nature of the intervention, it is not possible to mask patients or monitors in charge of supervising the execution of the exercise training.
Intervention model description
Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.
Eligibility
Sex/Gender
ALL
Age
6 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent oxygen consumption at ventilatory threshold | Change from baseline to 16 weeks | Change in percent oxygen consumption at ventilatory threshold will be evaluated through cardiopulmonary exercise testing (CPET). |
| Change in time to ventilatory threshold | Change from baseline to 16 weeks | Change in time to ventilatory threshold (minutes) will be evaluated through cardiopulmonary exercise testing (CPET). |
| Change in ventilatory efficiency | Change from baseline to 16 weeks | Change in ventilatory efficiency will be evaluated by combining ventilation (VE) and carbon dioxide production (VCO2) measurements to report VE/VCO2 ratio, evaluated through cardiopulmonary exercise testing (CPET). |
| Change in peak oxygen consumption | Change from baseline to 16 weeks | Change in peak oxygen consumption (mL/kg/min) will be evaluated through cardiopulmonary exercise testing (CPET). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle strength | Change from baseline to 16 weeks | Changes in muscle strength will be evaluated using a dynamometer. |
| Change in lower body strength | Change from baseline to 16 weeks | Changes in lower body strength will be evaluated using the 30 seconds Sit to Stand Test (30STS). |
| Change in free fat mass | Change from baseline to 16 weeks | Changes in free fat mass (percent) will be evaluated through bioimpedance. |
| Change in hip-waist ratio | Change from baseline to 16 weeks | Changes in hip-waist ratio will be evaluated by combining hip circumference and waist circumference measurements using a non-stretchable tape measure. |
| Change in body mass index | Change from baseline to 16 weeks | Changes in body mass index will be evaluated by combining weight and height measurements to report BMI (kg/m\^2). |
| Change in quality of life | Change from baseline to 16 weeks | Changes in quality of life will be evaluated through the Saint George's Respiratory Questionnaire (SRQ). The overall result of the scale is a numerical value from 0 to 100, with the highest values corresponding to a worse quality of life. |
| Change in dyspnea | Change from baseline to 16 weeks | Changes in dyspnea will be evaluated through the Medical Research Council (mMRC) modified dyspnea scale. The overall result of the scale is a numerical value from 0 to 4, where the highest value corresponds to the worse dyspnea. |
| Change in lean mass | Change from baseline to 16 weeks | Changes in lean mass (percent) will be evaluated through bioimpedance. |
| Change in forced expiratory volume in the first second | Change from baseline to 16 weeks | Change in forced expiratory volume in the first second (liters) will be evaluated through spirometry. |
| Change in forced vital capacity | Change from baseline to 16 weeks | Change in forced vital capacity (liters) will be evaluated through spirometry. |
| Change in forced expiratory flow between 25 and 75% of forced vital capacity | Change from baseline to 16 weeks | Change in forced expiratory flow between 25 and 75% of forced vital capacity (liters/minute) will be evaluated through spirometry. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Height in meters | Change from baseline to 16 weeks | Height will be evaluated using a stadiometer. |
| Daily physical activity level | Change from baseline to 16 weeks | Daily physical activity level will be evaluated through the physical activity questionnaire (PAQ). The overall test score is from 1 to 5 points, with a higher score indicating a higher level of activity. |
| Weight in kilograms | Change from baseline to 16 weeks | Weight will be evaluated using a weight scale. |
Countries
Spain
Outcome results
None listed