Inspiratory Muscle Training / Childhood Obesity / Obesity & Overweight · Interventional Study

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

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective registration for a planned 6-week randomized controlled trial comparing combined inspiratory muscle training and functional high-intensity interval training against usual activity in 50 boys aged 10–12 years with obesity. No results are yet reported in this registry record; the trial is in the recruitment phase and outcomes remain unknown.

What was studied

Interventional, Randomized, Parallel, Single masking, Supportive Care purpose. Obesity & Overweight, Childhood Obesity; Male; age from 10 Years; to 12 Years; accepts healthy volunteers. Intervention: Combined IMT + Functional HIIT. Compared with: Usual Activity Control — No Intervention. n = 50. 1 site: Turkey (Türkiye).

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for a planned interventional trial with no results posted; enrollment has not yet begun, making it an early-stage announcement of intent rather than evidence of efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Inspiratory Diaphragm Thickness (assessed at 6 weeks); Diaphragm Thickening Fraction (assessed at 6 weeks); Expiratory Diaphragm Thickness (assessed at 6 week)

DesignInterventional, Randomized, Parallel, Single masking, Supportive Care purpose

PopulationObesity & Overweight, Childhood Obesity; Male; age from 10 Years; to 12 Years; accepts healthy volunteers

Sample size50

InterventionCombined IMT + Functional HIIT

ComparatorUsual Activity Control — No Intervention

Setting1 site: Turkey (Türkiye)

Reported figures

Quoted from the source exactly as published.

Planned sample size50

Age range10–12 years

Intervention duration6 weeks

Primary outcome measure 1Inspiratory Diaphragm Thickness at 6 weeks

Primary outcome measure 2Diaphragm Thickening Fraction at 6 weeks

Primary outcome measure 3Expiratory Diaphragm Thickness at 6 weeks

Caveats

No results are posted in this registry record; recruitment has not yet begun (status: NOT_YET_RECRUITING).
Primary outcomes are surrogate measures (diaphragm morphology); no hard clinical endpoints (weight, metabolic markers, or functional capacity outcomes) are listed.
Comparator arm is described only as 'usual activity'; specific control intervention protocol not detailed.
No sample size justification, power calculation, or secondary outcome measures are reported in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized controlled trial planned; phase and comparator structure clearly stated in registration.

Directness

moderate

Interventions target respiratory and fitness outcomes directly; clinical relevance to childhood obesity management unclear.

Consistency

insufficient

No results reported; no prior published data from this trial available for comparison.

Risk of bias

insufficient

Registry record does not describe allocation concealment, blinding, or outcome adjudication.

Sample adequacy

limited

Planned enrollment 50 participants; small for a multi-outcome RCT; precision for individual endpoints unclear.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07810361). This is a study registration, not published results. Lead sponsor: Gümüşhane Universıty. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Obesity & Overweight, Childhood Obesity. Interventions: OTHER: Inspiratory Muscle Training; OTHER: Functional High-Intensity Interval Training. Primary outcome measures: Inspiratory Diaphragm Thickness , 6 weeks; Diaphragm Thickening Fraction , 6 weeks; Expiratory Diaphragm Thickness , 6 week. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Inspiratory Muscle TrainingChildhood ObesityGümüşhane UniversıtyObesity & OverweightFunctional High-Intensity Interval TrainingNCT07810361