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High Intensity Intervallic Training in Children With Bronchiolitis Obliterans

NCT ID: NCT05881538

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-29

Study Completion Date

2024-07-29

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchiolitis Obliterans

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise group

Intervention Type 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.

Control group

Routine physician recommendations for physical activity.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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High Intensity Interval Training

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consejo Superior de Deportes, Spain

OTHER

Sponsor Role collaborator

Universitat Internacional de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Márcio Vinícius Fagundes Donadio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Márcio VF Donadio, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Internacional de Catalunya

Locations

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Hospital Universitario Donostia

Donostia / San Sebastian, Basque Country, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, Spain

Site Status

Hospital Universitario Infantil Niño Jesús

Madrid, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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PIBOHIIT-UIC

Identifier Type: -

Identifier Source: org_study_id