High Intensity Intervallic Training in Children With Bronchiolitis Obliterans

Study Overview
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Brief Summary
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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 both Vall D'Hebrón University Hospital (Barcelona) and Niño Jesús University Hospital (Madrid). Criteria for participation: (I) Diagnosis of PIBO; (II) Clinically stable at the time of the assessments; (III) Age between 6 to 20 years old.

Official Title
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Effectiveness of a High-intensity Intervallic Training Program in Children and Adolescents With Post-infectious Bronchiolitis Obliterans: a Randomized Controlled Trial

Conditions
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Bronchiolitis Obliterans

Intervention / Treatment
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* Other: Exercise group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>16 weeks of a High Intensity Interval Training exercise program conducted telematically with real time supervision twice a week. The exercise program consists of a circuit of exercises aiming to achieve a target heart rate for each fitness level. | Other: Exercise group<br>* 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.<br>* Other names: High Intensity Interval Training;|
| No Intervention: Control group<br>Routine physician recommendations for physical activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak oxygen consumption | Change in peak oxygen consumption (mL/kg/min) will be evaluated through cardiopulmonary exercise testing (CPET). | Change from baseline to 16 weeks | 
| Change in time to ventilatory threshold | Change in time to ventilatory threshold (minutes) will be evaluated through cardiopulmonary exercise testing (CPET). | Change from baseline to 16 weeks | 
| Change in percent oxygen consumption at ventilatory threshold | Change in percent oxygen consumption at ventilatory threshold will be evaluated through cardiopulmonary exercise testing (CPET). | Change from baseline to 16 weeks | 
| Change in ventilatory efficiency | 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 from baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in forced expiratory volume in the first second | Change in forced expiratory volume in the first second (liters) will be evaluated through spirometry. | Change from baseline to 16 weeks | 
| Change in forced vital capacity | Change in forced vital capacity (liters) will be evaluated through spirometry. | Change from baseline to 16 weeks | 
| Change in forced expiratory flow between 25 and 75% of forced vital capacity | Change in forced expiratory flow between 25 and 75% of forced vital capacity (liters/minute) will be evaluated through spirometry. | Change from baseline to 16 weeks | 
| Change in muscle strength | Changes in muscle strength will be evaluated using a dynamometer. | Change from baseline to 16 weeks | 
| Change in lower body strength | Changes in lower body strength will be evaluated using the 30 seconds Sit to Stand Test (30STS). | Change from baseline to 16 weeks | 
| Change in free fat mass | Changes in free fat mass (percent) will be evaluated through bioimpedance. | Change from baseline to 16 weeks | 
| Change in lean mass | Changes in lean mass (percent) will be evaluated through bioimpedance. | Change from baseline to 16 weeks | 
| Change in hip-waist ratio | Changes in hip-waist ratio will be evaluated by combining hip circumference and waist circumference measurements using a non-stretchable tape measure. | Change from baseline to 16 weeks | 
| Change in body mass index | Changes in body mass index will be evaluated by combining weight and height measurements to report BMI (kg/m^2). | Change from baseline to 16 weeks | 
| Change in quality of life | 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 from baseline to 16 weeks | 
| Change in dyspnea | 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 from baseline to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telematic program, High intensity interval training, Post-infectious bronchiolitis obliterans, Cardiorespiratory fitness