High Intensity Intervallic Training in Children With Bronchiolitis Obliterans

NCT05881538 | Completed

• 1 other identifier: PIBOHIIT-UIC
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

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.

Conditions

Bronchiolitis Obliterans

Keywords

High intensity interval training; Post-infectious bronchiolitis obliterans; Telematic program; Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Change in forced expiratory volume in the first second

  Change from baseline to 16 weeks

• Change in forced vital capacity

  Change from baseline to 16 weeks

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

  Change from baseline to 16 weeks

• Change in muscle strength

  Change from baseline to 16 weeks

• Change in lower body strength

  Change from baseline to 16 weeks

Other Outcomes (3)

• Height in meters

  Change from baseline to 16 weeks

• Weight in kilograms

  Change from baseline to 16 weeks

• Daily physical activity level

  Change from baseline to 16 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Routine physician recommendations for physical activity.

Interventions

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.

Also known as: High Intensity Interval Training

Exercise group

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Postinfectious bronchiolitis obliterans;
• Clinical stability at the time of the assessments;
• Age between 6 and 20 years old.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead
• Consejo Superior de Deportes, Spain: collaborator

Study Sites (3)

Hospital Universitario Donostia

Donostia / San Sebastian, Basque Country, 20014, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Universitario Infantil Niño Jesús

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Márcio VF Donadio, PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 31, 2023
• Study Start: May 29, 2023
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: Access will be given only to the researchers of the study.

Locations

ES (3)