- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07810361
Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training in Boys With Obesity (IMT and HIIT)
Combined Inspiratory Muscle Training and Functional High-Intensity Interval Training Promote Respiratory, Diaphragmatic, and Aerobic Adaptations in Children With Obesity
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Coşkun Yılmaz, Associate professor
- Telefonnummer: +905424427444
- E-mail: coskun.yilmaz@gumushane.edu.tr
Studiesteder
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Gümüşhane Province
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Trabzon, Gümüşhane Province, Tyrkiet (Türkiye), 29000
- Gumushane University
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Kontakt:
- Coşkun Yılmaz, Associate professor
- Telefonnummer: 05424427444
- E-mail: coskun.yilmaz@gumushane.edu.tr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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 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.
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Inspiratory Diaphragm Thickness
Tidsramme: 6 weeks
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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.
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6 weeks
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Diaphragm Thickening Fraction
Tidsramme: 6 weeks
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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.
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6 weeks
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Expiratory Diaphragm Thickness
Tidsramme: 6 week
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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.
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6 week
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maximal Inspiratory Pressure
Tidsramme: 6 week
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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.
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6 week
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Maximal Expiratory Pressure
Tidsramme: 6 week
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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.
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6 week
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Forced Vital Capacity
Tidsramme: 6 week
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Forced vital capacity (FVC) was measured using spirometry according to ATS/ERS recommendations.
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6 week
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Forced Expiratory Volume in One Second
Tidsramme: 6 week
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Forced expiratory volume in one second (FEV₁) was measured using spirometry according to ATS/ERS recommendations.
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6 week
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FEV₁/FVC Ratio
Tidsramme: 6 week
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The FEV₁/FVC ratio was calculated from spirometric measurements obtained according to ATS/ERS recommendations.
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6 week
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Six-Minute Walk Distance
Tidsramme: 6 week
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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.
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6 week
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Estimated VO2max
Tidsramme: 6 week
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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.
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6 week
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Body Mass Index
Tidsramme: 6 week
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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.
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6 week
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Rating of Perceived Exertion
Tidsramme: 6 week
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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.
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6 week
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Height
Tidsramme: 6 Week
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Body composition was assessed using a multi-frequency bioelectrical impedance analyzer.
Height was assessed according to standardized procedures.
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6 Week
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Weight
Tidsramme: 6 Week
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Body composition was assessed using a multi-frequency bioelectrical impedance analyzer.
Weight was assessed according to standardized procedures.
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6 Week
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026/025
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