High Intensity Intervallic Training in Children With Bronchiolitis Obliterans

Bronchiolitis Obliterans Clinical Trial

— PIBOHIIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881538
• Other study ID #: PIBOHIIT-UIC
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2023
• Est. completion date: September 2024

Study information

• Verified date: August 2023
• Source: Universitat Internacional de Catalunya
• Contact: Márcio VF Donadio, PhD
• Phone: +34 93 504 20 00
• Email: mdonadio[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Bronchiolitis Obliterans Syndrome

Intervention

Other:
• Exercise 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Catalunya
Spain	Hospital Universitario Infantil Niño Jesús	Madrid
Spain	Hospital Universitario Donostia	San Sebastián	País Vasco

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya	Consejo Superior de Deportes

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height in meters	Height will be evaluated using a stadiometer.	Change from baseline to 16 weeks
Other	Weight in kilograms	Weight will be evaluated using a weight scale.	Change from baseline to 16 weeks
Other	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.	Change from baseline to 16 weeks
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Change in forced vital capacity	Change in forced vital capacity (liters) will be evaluated through spirometry.	Change from baseline to 16 weeks
Secondary	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
Secondary	Change in muscle strength	Changes in muscle strength will be evaluated using a dynamometer.	Change from baseline to 16 weeks
Secondary	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
Secondary	Change in free fat mass	Changes in free fat mass (percent) will be evaluated through bioimpedance.	Change from baseline to 16 weeks
Secondary	Change in lean mass	Changes in lean mass (percent) will be evaluated through bioimpedance.	Change from baseline to 16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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