PIBOHIIT: High Intensity Intervallic Training in Children With Bronchiolitis Obliterans

Sponsor

Universitat Internacional de Catalunya (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05881538

Collaborator

Consejo Superior de Deportes (Other)

Enrollment

Arms

15.1

Anticipated Duration (Months)

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans	Other: Exercise group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

The evaluators and care providers will be masked to the allocation of the patients. Given the nature of the intervention, it is not possible to mask patients or monitors in charge of supervising the execution of the exercise training.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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 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 free fat mass [Change from baseline to 16 weeks]
Changes in free fat mass (percent) will be evaluated through bioimpedance.
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 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 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.
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.

Other Outcome Measures

Height in meters [Change from baseline to 16 weeks]
Height will be evaluated using a stadiometer.
Weight in kilograms [Change from baseline to 16 weeks]
Weight will be evaluated using a weight scale.
Daily physical activity level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.