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NCT Number: NCT07810361

Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training in Boys 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.

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Key information

Age range

10 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Gumushane Üniversity

Trabzon, Gümüşhane Province, 29000, Turkey (Türkiye)

Location contact

Coşkun Yılmaz, Associate professor

CONTACT

[email protected]

05424427444

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory Muscle Training

Other

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.

Functional High-Intensity Interval Training

Other

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.

Primary outcomes

  1. Inspiratory Diaphragm Thickness

    Time frame: 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.

  2. Diaphragm Thickening Fraction

    Time frame: 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.

  3. Expiratory Diaphragm Thickness

    Time frame: 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.

Secondary outcomes

  1. Maximal Inspiratory Pressure

    Time frame: 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.

  2. Maximal Expiratory Pressure

    Time frame: 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.

  3. Forced Vital Capacity

    Time frame: 6 week

    Forced vital capacity (FVC) was measured using spirometry according to ATS/ERS recommendations.

  4. Forced Expiratory Volume in One Second

    Time frame: 6 week

    Forced expiratory volume in one second (FEV₁) was measured using spirometry according to ATS/ERS recommendations.

  5. FEV₁/FVC Ratio

    Time frame: 6 week

    The FEV₁/FVC ratio was calculated from spirometric measurements obtained according to ATS/ERS recommendations.

  6. Six-Minute Walk Distance

    Time frame: 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.

  7. Estimated VO2max

    Time frame: 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.

  8. Body Mass Index

    Time frame: 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.

  9. Rating of Perceived Exertion

    Time frame: 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.

  10. Height

    Time frame: 6 Week

    Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Height was assessed according to standardized procedures.

  11. Weight

    Time frame: 6 Week

    Body composition was assessed using a multi-frequency bioelectrical impedance analyzer. Weight was assessed according to standardized procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Coşkun Yılmaz, Associate professor

CONTACT

[email protected]

+905424427444

Sponsors and collaborators

Lead sponsor

Gümüşhane Universıty

Other

Registry information

Official study title

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

Acronym: IMT and HIIT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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