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

U

Universitat Internacional de Catalunya

Status

Completed

Conditions

Bronchiolitis Obliterans

Treatments

Other: Exercise group

Study type

Interventional

Funder types

Other

Identifiers

NCT05881538
PIBOHIIT-UIC

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

6 to 20 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

51 participants in 2 patient groups

Exercise group
Experimental group
Description:
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.
Treatment:
Other: Exercise group
Control group
No Intervention group
Description:
Routine physician recommendations for physical activity.

Trial documents
1

Trial contacts and locations

3

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Central trial contact

Márcio VF Donadio, PhD; Inès de Mir Messa, MD PhD

Data sourced from clinicaltrials.gov

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