ClinicalTrials.gg
Not yet recruitingNCT07810361IMT and HIITUpdated Sep 9, 2026

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

An interventional study of Inspiratory Muscle Training and Functional High-Intensity Interval Training in Obesity & Overweight and Childhood Obesity, sponsored by Gümüşhane Universıty. Not yet recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Primary conditionPediatric ObesityRegistry: ObesityReclassifiedWhy we changed it
Registry
Obesity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pediatric Obesity
Why
  1. The study's listed conditions name Pediatric Obesity, a narrower term within Obesity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Gümüşhane Universıty · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
10 Years to 12 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Pediatric Obesity with a site in Turkey — 5 open to participants now, 5 under way, none of them phase 3. Pediatric Obesity · Turkey.

Planned enrollment
13th of 20
50 · median 57
Started
2026
with 3 others
No phase
19 of 30
3 open now
Registered
29th of 30
by date
Lead sponsor
1 of 30
Gümüşhane Universıty

Among the 30 studies in Pediatric Obesity with a site in Turkey, this one is the 13th largest by planned enrollment of the 20 interventional ones that give a count, is one of 4 that started in 2026, is one of 19 with no phase, and was the 29th registered.

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

Browse Pediatric Obesity studies →

Open to participants now

5 of the 30 studies in Pediatric Obesity with a site in Turkey are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 124 Pediatric Obesity studies recruiting now, 19 (15%) set no upper age limit and 103 (83%) stop at 75 or younger; 114 take children under 18; 69 take healthy volunteers.

This study: 10 Years to 12 Years · male · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Pediatric Obesity with a site in Turkey, or all of them as a file.
02

Study 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.

Read the detailed description

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

03

Conditions studied

  • Obesity & Overweight
  • Childhood Obesity

Browse trials for

Keywords

  • childhood obesity
  • inspiratory muscle training
  • high-intensity interval training
  • aerobic fitness
  • exercise-related metabolic health
  • functional exercise capacity
  • six-minute walk test
  • diaphragm thickness
04

In context

Pediatric Obesity Reclassified

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Gümüşhane Universıty is the lead sponsor of 34 studies on the registry; 5 are open to participants now.

Compared within Pediatric Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obesity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
10 Years to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male sex.
  • Age 10-12 years.

    *Obesity according to World Health Organization age- and sex-specific 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

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 /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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

06

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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.

    Other: Inspiratory Muscle Training · Other: Functional High-Intensity Interval Training

  • No intervention
    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.

Interventions

  • OtherInspiratory 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.

  • OtherFunctional 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.

07

What researchers measure

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 weeks

  2. 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 weeks

  3. 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 week

Secondary 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 week

  2. 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 week

  3. Forced Vital Capacity

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

    Time frame: 6 week

  4. 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 week

  5. FEV₁/FVC Ratio

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

    Time frame: 6 week

  6. Six-Minute Walk Distance

    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.

    Time frame: 6 week

  7. Estimated VO2max

    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.

    Time frame: 6 week

  8. Body Mass Index

    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.

    Time frame: 6 week

  9. Rating of Perceived Exertion

    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.

    Time frame: 6 week

  10. Height

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

    Time frame: 6 Week

  11. Weight

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

    Time frame: 6 Week

08

Study locations

1 site
  • Gumushane Üniversity
    Trabzon, Gümüşhane Province 29000, Turkey (Türkiye)
09

References and documents

Publications

  • Kaeotawee P, Udomittipong K, Nimmannit A, Tovichien P, Palamit A, Charoensitisup P, Mahoran K. Effect of Threshold Inspiratory Muscle Training on Functional Fitness and Respiratory Muscle Strength Compared to Incentive Spirometry in Children and Adolescents With Obesity: A Randomized Controlled Trial. Front Pediatr. 2022 Jul 7;10:942076. doi: 10.3389/fped.2022.942076. eCollection 2022. PubMed 35874588 ↗
  • Deng Y, Wang X. Effect of high-intensity interval training on cardiorespiratory in children and adolescents with overweight or obesity: a meta-analysis of randomized controlled trials. Front Public Health. 2024 Jan 26;12:1269508. doi: 10.3389/fpubh.2024.1269508. eCollection 2024. PubMed 38344230 ↗
  • Caicedo-Trujillo S, Torres-Castro R, Vasconcello-Castillo L, Solis-Navarro L, Sanchez-Ramirez D, Nunez-Cortes R, Vera-Uribe R, Munoz-Munoz I, Barros-Poblete M, Romero JE, Vilaro J. Inspiratory muscle training in patients with obesity: a systematic review and meta-analysis. Front Med (Lausanne). 2023 Nov 27;10:1284689. doi: 10.3389/fmed.2023.1284689. eCollection 2023. PubMed 38089877 ↗
  • Vanhelst J, Fardy PS, Salleron J, Beghin L. The six-minute walk test in obese youth: reproducibility, validity, and prediction equation to assess aerobic power. Disabil Rehabil. 2013 Mar;35(6):479-82. doi: 10.3109/09638288.2012.699581. Epub 2012 Jul 10. PubMed 22779759 ↗
  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available. PubMed 12186831 ↗

Individual participant data

Plan to share: No — 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.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2026, 1 month later.

Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 1 month is below that.

Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 9, 2026
StartEst.
Oct 20, 2026
Primary completionEst.
Dec 15, 2026
CompletionEst.
Dec 20, 2026
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07810361
Lead sponsor
Gümüşhane Universıty
Responsible party
Coşkun YILMAZ (Associate professor, Gümüşhane Universıty) — Principal investigator
First posted
Sep 9, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Sep 9, 2026

Study contacts

Coşkun Yılmaz, Associate professor
Contact
coskun.yilmaz@gumushane.edu.tr
+905424427444

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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