Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

3 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Gümüşhane Province
      • Trabzon, Gümüşhane Province, Turquía (Türkiye), 29000
        • Gumushane University
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: 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.
Otro: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Inspiratory Diaphragm Thickness
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maximal Inspiratory Pressure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 week
Forced vital capacity (FVC) was measured using spirometry according to ATS/ERS recommendations.
6 week
Forced Expiratory Volume in One Second
Periodo de tiempo: 6 week
Forced expiratory volume in one second (FEV₁) was measured using spirometry according to ATS/ERS recommendations.
6 week
FEV₁/FVC Ratio
Periodo de tiempo: 6 week
The FEV₁/FVC ratio was calculated from spirometric measurements obtained according to ATS/ERS recommendations.
6 week
Six-Minute Walk Distance
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 Week
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Height was assessed according to standardized procedures.
6 Week
Weight
Periodo de tiempo: 6 Week
Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Weight was assessed according to standardized procedures.
6 Week

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Gümüşhane Universıty

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de octubre de 2026

Finalización primaria (Estimado)

15 de diciembre de 2026

Finalización del estudio (Estimado)

20 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

1 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Publicado por primera vez (Actual)

9 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026/025

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir