High Intensity Intervallic Training in Children With Bronchiolitis Obliterans (PIBOHIIT)

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis Obliterans
• Intervention / Treatment: Other: Exercise group

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Hospital Universitario Infantil Nino Jesus
  • Catalunya
    • Barcelona, Catalunya, Spain, 08035
      • Hospital Universitari Vall d'Hebron
  • País Vasco
    • San Sebastián, País Vasco, Spain, 20014
      • Hospital Universitario Donostia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: High Intensity Interval Training
No Intervention: Control group; Routine physician recommendations for physical activity.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height in meters	Height will be evaluated using a stadiometer.	Change from baseline to 16 weeks
Weight in kilograms	Weight will be evaluated using a weight scale.	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.	Change from baseline to 16 weeks

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Collaborators: Consejo Superior de Deportes
• Investigators: Principal Investigator: Márcio VF Donadio, PhD, Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): July 29, 2024
• Study Completion (Actual): July 29, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: High intensity interval training; Cardiorespiratory fitness; Post-infectious bronchiolitis obliterans; Telematic program
• Additional Relevant MeSH Terms: Organizing Pneumonia; Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Bronchiolitis; Bronchiolitis Obliterans
• Other Study ID Numbers: PIBOHIIT-UIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After completion of study, the data will be stored for as long as necessary to meet any possible responsibilities derived from the study.
• IPD Sharing Access Criteria: Access will be given only to the researchers of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No