Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training in Boys With Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age10-12
SponsorGümüşhane Universıty
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male sex.
Age 10-12 years.
No regular participation in structured exercise training during the preceding six months.
Medical clearance to participate in moderate-to-vigorous physical activity.
Disqualifiers
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%.
Medication use that could affect respiratory function or exercise capacity.
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratory Muscle Training
Other interventionInspiratory 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 interventionFunctional 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Combined IMT + Functional HIITExperimental treatment 2 interventions
Group B: Usual Activity ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Inspiratory Diaphragm Thickness
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.
Time frame
6 weeks2
Diaphragm Thickening Fraction
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.
Time frame
6 weeks3
Expiratory Diaphragm Thickness
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.
Time frame
6 weekSecondary outcomes
1
Maximal Inspiratory Pressure
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.
Time frame
6 week2
Maximal Expiratory Pressure
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.
Time frame
6 week3
Forced Vital Capacity
Forced vital capacity (FVC) was measured using spirometry according to ATS/ERS recommendations.
Time frame
6 week4
Forced Expiratory Volume in One Second
Forced expiratory volume in one second (FEV₁) was measured using spirometry according to ATS/ERS recommendations.
Time frame
6 weekLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Gumushane Üniversity Status unavailable 29000, Trabzon, Gümüşhane ProvinceTurkey (Türkiye)
Sponsors and contacts
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Source ClinicalTrials.gov
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