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Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training in Boys With Obesity (IMT and HIIT)

3 septembre 2026 mis à jour par: Coşkun YILMAZ, Gümüşhane Universıty

Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training Promote Respiratory, Diaphragmatic, and Aerobic Adaptations in Children With Obesity

Childhood obesity is associated with reduced cardiorespiratory fitness, impaired exercise tolerance, and altered respiratory mechanics. This randomized controlled trial investigated whether combining inspiratory muscle training with functional high-intensity interval training improves diaphragm morphology, respiratory muscle strength, pulmonary function, aerobic fitness, and functional exercise capacity in boys with obesity. Fifty boys aged 10-12 years were randomly assigned to six weeks of combined inspiratory muscle training and functional high-intensity interval training or usual activity.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This prospective, two-arm, randomized controlled trial investigated the effects of a six-week combined inspiratory muscle training and functional high-intensity interval training program in boys aged 10-12 years with obesity.

Fifty participants were randomly allocated in a 1:1 ratio to either a combined training group or a usual-activity control group. The intervention consisted of progressive inspiratory muscle training performed five days per week and functional high-intensity interval training performed three non-consecutive days per week for six weeks.

Inspiratory muscle training was performed using a threshold pressure-loading device. Training commenced at 30% of maximal inspiratory pressure and increased by 5% each week, reaching 55% of maximal inspiratory pressure in week 6. Each session consisted of two sets of 30 inspiratory efforts.

Functional high-intensity interval training was performed three times per week. Each approximately 35-40-minute session consisted of a standardized warm-up, a functional high-intensity interval circuit, and a cool-down. The circuit included wall sit, incline push-up, seated knee-to-chest exercise, shadow boxing, Superman exercise, and low-step-up exercise. Training intensity was progressively increased by manipulating work-to-rest ratios and circuit volume.

The control group continued habitual daily activities without participating in structured exercise or respiratory muscle training during the six-week study period.

Primary outcomes were diaphragm thickening fraction, inspiratory diaphragm thickness, and expiratory diaphragm thickness. Secondary outcomes included maximal inspiratory pressure, maximal expiratory pressure, forced vital capacity, forced expiratory volume in one second, FEV₁/FVC ratio, six-minute walk distance, estimated VO₂max, body composition, and perceived exertion.

Assessments were performed at baseline and after the six-week intervention under standardized laboratory conditions between 15:00 and 17:00. Diaphragm ultrasonography was performed by a radiologist blinded to group allocation

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Turquie (Türkiye)
    • Gümüşhane Province
      • Trabzon, Gümüşhane Province, Turquie (Türkiye), 29000

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Male sex.

  • Age 10-12 years.

    *Obesity according to World Health Organization age- and sex-specific BMI reference criteria.

  • No regular participation in structured exercise training during the preceding six months.
  • Medical clearance to participate in moderate-to-vigorous physical activity.

Exclusion Criteria:

  • Diagnosed cardiovascular, neuromuscular, orthopaedic, or metabolic conditions that could interfere with exercise participation.
  • Chronic respiratory disease, including asthma requiring regular medication.

  • Impaired pulmonary function defined as FEV₁/FVC <75%.

    *Upper respiratory tract infection within the preceding two weeks.

  • Medication use that could affect respiratory function or exercise capacity.
  • Previous thoracic surgery.
  • Inability to complete the testing procedures.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Combined IMT + Functional HIIT
Participants received six weeks of combined inspiratory muscle training and functional high-intensity interval training in addition to their usual daily activities. Inspiratory muscle training was performed five days per week, and functional high-intensity interval training was performed three non-consecutive days per week.
Autre: Inspiratory Muscle Training
Inspiratory muscle training was performed using a threshold pressure-loading device (POWERbreathe). Participants trained once daily, five days per week, for six consecutive weeks. Each session consisted of two sets of 30 inspiratory efforts. Training began at 30% of maximal inspiratory pressure in week 1, with the training load progressively increased by 5% each week to reach 55% of maximal inspiratory pressure in week 6. Training pressure was reassessed weekly, and all sessions were supervised by a certified exercise specialist.
Autre: Functional High-Intensity Interval Training
Functional high-intensity interval training was performed three times per week on non-consecutive days for six weeks. Each session lasted approximately 35-40 minutes and consisted of an approximately 8-minute warm-up, a functional high-intensity interval circuit, and an approximately 5-minute cool-down. The circuit included wall sit, incline push-up, seated knee-to-chest exercise, shadow boxing, Superman exercise, and low-step-up exercise. Training intensity was progressively increased by manipulating work-to-rest ratios and the number of circuit cycles. Perceived exertion was monitored using the Borg CR-10 scale.
Aucune intervention: Usual Activity Control
Participants continued their habitual daily activities throughout the six-week study period and did not participate in structured exercise or respiratory muscle training. They were instructed not to initiate a new exercise program until study completion.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Inspiratory Diaphragm Thickness
Délai: 6 weeks
Inspiratory diaphragm thickness (DTins) was measured by ultrasound at the end of maximal inspiration at the zone of apposition of the right hemidiaphragm. Three measurements were obtained and averaged. The measurement represents an ultrasound-derived index of diaphragm morphology.
6 weeks
Diaphragm Thickening Fraction
Délai: 6 weeks
Diaphragm thickening fraction (DTf) was assessed using diaphragm ultrasonography and calculated as [(end-inspiratory diaphragm thickness - end-expiratory diaphragm thickness) / end-expiratory diaphragm thickness] × 100. Measurements were obtained from the right hemidiaphragm at the zone of apposition. Three measurements were obtained in each respiratory phase and averaged for analysis.
6 weeks
Expiratory Diaphragm Thickness
Délai: 6 week
Expiratory diaphragm thickness (DTexp) was measured by ultrasound at the end of maximal expiration at the zone of apposition of the right hemidiaphragm. Three measurements were obtained and averaged. The measurement represents an ultrasound-derived index of diaphragm morphology.
6 week

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Maximal Inspiratory Pressure
Délai: 6 week
Maximal inspiratory pressure (MIP) was measured using a handheld mouth pressure meter according to ATS/ERS recommendations. Measurements were performed from residual volume, and the best reproducible values were recorded in cmH₂O.
6 week
Maximal Expiratory Pressure
Délai: 6 week
Maximal expiratory pressure (MEP) was measured using a handheld mouth pressure meter according to ATS/ERS recommendations. Measurements were performed from total lung capacity, and the best reproducible values were recorded in cmH₂O.
6 week
Forced Vital Capacity
Délai: 6 week
Forced vital capacity (FVC) was measured using spirometry according to ATS/ERS recommendations.
6 week
Forced Expiratory Volume in One Second
Délai: 6 week
Forced expiratory volume in one second (FEV₁) was measured using spirometry according to ATS/ERS recommendations.
6 week
FEV₁/FVC Ratio
Délai: 6 week
The FEV₁/FVC ratio was calculated from spirometric measurements obtained according to ATS/ERS recommendations.
6 week
Six-Minute Walk Distance
Délai: 6 week
Functional exercise capacity was assessed using the Six-Minute Walk Test. Participants walked for six minutes along a pre-measured, flat, straight corridor at a self-selected comfortable pace. The total distance covered in meters was recorded.
6 week
Estimated VO2max
Délai: 6 week
Estimated maximal oxygen uptake (VO₂max) was calculated from six-minute walk distance and body mass index using the validated prediction equation developed for children and adolescents with obesity: VO₂max = 26.9 + (0.014 × 6MWD [m]) - (0.38 × BMI [kg/m²]). VO₂max values were estimated and were not directly measured by cardiopulmonary exercise testing.
6 week
Body Mass Index
Délai: 6 week
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Body mass index (BMI) and BMI z-score were assessed according to standardized procedures.
6 week
Rating of Perceived Exertion
Délai: 6 week
Perceived exercise intensity was assessed using the Borg Category Ratio-10 Rating of Perceived Exertion scale. Participants were familiarized with the scale before the intervention, and RPE was recorded immediately after each functional HIIT session throughout the six-week intervention period.
6 week
Height
Délai: 6 Week
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Height was assessed according to standardized procedures.
6 Week
Weight
Délai: 6 Week
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Weight was assessed according to standardized procedures.
6 Week

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gümüşhane Universıty

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

20 octobre 2026

Achèvement primaire (Estimé)

15 décembre 2026

Achèvement de l'étude (Estimé)

20 décembre 2026

Dates d'inscription aux études

Première soumission

1 septembre 2026

Première soumission répondant aux critères de contrôle qualité

3 septembre 2026

Première publication (Réel)

9 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026/025

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be publicly shared. The raw data supporting the conclusions of the study will be made available by the authors upon reasonable request, subject to applicable ethical, institutional, and data-protection requirements.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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