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

3 сентября 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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

Тип исследования

Интервенционный

Регистрация (Оцененный)

50

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Coşkun Yılmaz, Associate professor
  • Номер телефона: +905424427444
  • Электронная почта: coskun.yilmaz@gumushane.edu.tr

Места учебы

  • Турция (Туркие)
    • Gümüşhane Province
      • Trabzon, Gümüşhane Province, Турция (Туркие), 29000
        • Gumushane University
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Да

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Другой: 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.
Другой: 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.
Без вмешательства: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Inspiratory Diaphragm Thickness
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Gümüşhane Universıty

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

20 октября 2026 г.

Первичное завершение (Оцененный)

15 декабря 2026 г.

Завершение исследования (Оцененный)

20 декабря 2026 г.

Даты регистрации исследования

Первый отправленный

1 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

3 сентября 2026 г.

Первый опубликованный (Действительный)

9 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 2026/025

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана 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.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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