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NCT Number: NCT05881538

High Intensity Intervallic Training in Children With Bronchiolitis Obliterans

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.

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Key information

Conditions

Bronchiolitis Obliterans Bronchial Diseases Bronchiolitis Bronchitis Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

Age range

6 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Donostia, Donostia / San Sebastian, Basque Country, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise group

Other

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

Primary outcomes

  1. Change in peak oxygen consumption

    Time frame: Change from baseline to 16 weeks

    Change in peak oxygen consumption (mL/kg/min) will be evaluated through cardiopulmonary exercise testing (CPET).

  2. Change in time to ventilatory threshold

    Time frame: Change from baseline to 16 weeks

    Change in time to ventilatory threshold (minutes) will be evaluated through cardiopulmonary exercise testing (CPET).

  3. Change in percent oxygen consumption at ventilatory threshold

    Time frame: Change from baseline to 16 weeks

    Change in percent oxygen consumption at ventilatory threshold will be evaluated through cardiopulmonary exercise testing (CPET).

  4. Change in ventilatory efficiency

    Time frame: 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).

Secondary outcomes

  1. Change in forced expiratory volume in the first second

    Time frame: Change from baseline to 16 weeks

    Change in forced expiratory volume in the first second (liters) will be evaluated through spirometry.

  2. Change in forced vital capacity

    Time frame: Change from baseline to 16 weeks

    Change in forced vital capacity (liters) will be evaluated through spirometry.

  3. Change in forced expiratory flow between 25 and 75% of forced vital capacity

    Time frame: 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.

  4. Change in muscle strength

    Time frame: Change from baseline to 16 weeks

    Changes in muscle strength will be evaluated using a dynamometer.

  5. Change in lower body strength

    Time frame: Change from baseline to 16 weeks

    Changes in lower body strength will be evaluated using the 30 seconds Sit to Stand Test (30STS).

  6. Change in free fat mass

    Time frame: Change from baseline to 16 weeks

    Changes in free fat mass (percent) will be evaluated through bioimpedance.

  7. Change in lean mass

    Time frame: Change from baseline to 16 weeks

    Changes in lean mass (percent) will be evaluated through bioimpedance.

  8. Change in hip-waist ratio

    Time frame: 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.

  9. Change in body mass index

    Time frame: 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).

  10. Change in quality of life

    Time frame: 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.

  11. Change in dyspnea

    Time frame: 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.

Other outcomes

  1. Height in meters

    Time frame: Change from baseline to 16 weeks

    Height will be evaluated using a stadiometer.

  2. Weight in kilograms

    Time frame: Change from baseline to 16 weeks

    Weight will be evaluated using a weight scale.

  3. Daily physical activity level

    Time frame: Change from baseline to 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Collaborators

  • Consejo Superior de Deportes, Spain

Registry information

Official study title

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

Acronym: PIBOHIIT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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