High Intensity Intervallic Training in Children With Bronchiolitis Obliterans
- Conditions
- Bronchiolitis Obliterans
- Interventions
- Other: Exercise group
- Registration Number
- NCT05881538
- Lead Sponsor
- Universitat Internacional de Catalunya
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Diagnosis of Postinfectious bronchiolitis obliterans;
- Clinical stability at the time of the assessments;
- Age between 6 and 20 years old.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group Exercise group 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.
- Primary Outcome Measures
Name Time Method 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 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).
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).
- Secondary Outcome Measures
Name Time Method 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.
Change in free fat mass Change from baseline to 16 weeks Changes in free fat mass (percent) will be evaluated through bioimpedance.
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 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 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 lean mass Change from baseline to 16 weeks Changes in lean 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 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.
Trial Locations
- Locations (3)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Catalunya, Spain
Hospital Universitario Donostia
🇪🇸San Sebastián, País Vasco, Spain
Hospital Universitario Infantil Niño Jesús
🇪🇸Madrid, Spain