An interventional study of Exercise group in Bronchiolitis Obliterans, sponsored by Universitat Internacional de Catalunya. Completed at 3 sites in Spain. Open to participants aged 6 Years to 20 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Treatment
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.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Universitat Internacional de Catalunya is the lead sponsor of 144 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Routine physician recommendations for physical activity.
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.
Also known as: High Intensity Interval Training
Change in peak oxygen consumption
Change in peak oxygen consumption (mL/kg/min) will be evaluated through cardiopulmonary exercise testing (CPET).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline to 16 weeks
Change in forced expiratory volume in the first second
Change in forced expiratory volume in the first second (liters) will be evaluated through spirometry.
Time frame: Change from baseline to 16 weeks
Change in forced vital capacity
Change in forced vital capacity (liters) will be evaluated through spirometry.
Time frame: 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.
Time frame: Change from baseline to 16 weeks
Change in muscle strength
Changes in muscle strength will be evaluated using a dynamometer.
Time frame: 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).
Time frame: Change from baseline to 16 weeks
Change in free fat mass
Changes in free fat mass (percent) will be evaluated through bioimpedance.
Time frame: Change from baseline to 16 weeks
Change in lean mass
Changes in lean mass (percent) will be evaluated through bioimpedance.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 16 weeks
Height in meters
Height will be evaluated using a stadiometer.
Time frame: Change from baseline to 16 weeks
Weight in kilograms
Weight will be evaluated using a weight scale.
Time frame: Change from baseline to 16 weeks
Daily physical activity level
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.
Time frame: Change from baseline to 16 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators will collect patients' personal data and clinical history by means of the information delivered by the participating hospital. These data will be stored and coded in an Excel file in order to protect confidentiality before, during and after the study. All information will be entered and stored electronically in the institutional platform REDCAP hosted on the hospitals' server.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Universitat Internacional de Catalunya