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临床试验/NCT07307417
NCT07307417招募中不适用

Functional Respiratory Tract Dysfunctions in Individuals With Obesity Undergoing Experimental Inspiratory Muscle Training.

Wroclaw University of Health and Sport Sciences2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Pulmonary function test

研究概览

简要总结

The aim of the project will be to assess the functional condition of the respiratory tract and inflammation resulting from obesity, as well as the possibility of using inspiratory muscle training as a factor reducing the occurrence of dysfunction in the respiratory system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed obesity, BMI equal to or greater than 30 kg/m2
  • age between 30 and 60 (women and men),
  • consent of the subject.

排除标准

  • respiratory diseases requiring pharmacological treatment,
  • acute illness that may affect the training programme: e.g. infection, renal failure,
  • mental impairment preventing cooperation,
  • mental disorders preventing contact and cooperation with the patient,
  • pacemaker,
  • pregnancy
  • implanted electronic
  • medical implants
  • metal implants.

研究组 & 干预措施

IMT Group

Experimental

干预措施: inspiratory muscle training (Device)

placebo-IMT

Placebo Comparator

干预措施: placebo-IMT (Device)

Control group

No Intervention

No Intervention: IMT Control Group - IMT Control Group - participants who will not complete the IMT cycle.

结局指标

主要结局

Pulmonary function test

时间窗: Baseline and after 6 weeks (post-intervention)

Respiratory function testing (spirometry) will be performed in accordance with the guidelines of the American Thoracic Society and the European Respiratory Society. The respiratory function test will include the following parameters: forced vital capacity (FVC)\[FVC in liters\], forced expiratory volume in one second (FEV1) \[FEV1 in liters\], peak expiratory flow (PEF)\[PEF in liters/second\], vital capacity (VC) \[VC in liters\], maximum expiratory flow at 25%, 50% and 75% FVC (MEF 25-75%) \[MEF 25-75% in liters\], maximal inspiratory flow (MIF50) \[MIF in liters\], maximal expiratory Flow at 50% of vital capacity (MEF50) and maximal inspiratory flow at 50% of vital capacity (MIF50) (MEF50/MIF50) \[MEF50/MIF50 in liters\].

Respiratory muscle strength (PImax/PEmax)

时间窗: Baseline and after 6 weeks (post-intervention)

Respiratory Muscle Strength (PImax/PEmax) by assessing maximum inspiratory pressure (PImax in kilopascal,kPa) and expiratory pressure (PEmax in kilopascal,kPa). This measurement is to evaluate the potential effect of the intervention on the strength of inspiratory and expiratory muscles, particularly the potential to improve respiratory muscle performance and enhance overall ventilatory capacity in individuals with reduced respiratory muscle strength.

Forced oscillation technique (FOT)

时间窗: Baseline and after 6 weeks (post-intervention)

respiratory mechanics parameter: resistance (Rrs)\[Rrs in kPa·s·L-¹\], reactance (Xrs) \[Xrs in kPa·s·L-¹\], resonant Frequency (Fres): The frequency where Xrs = 0 (reactance cancels out). This measurement is to evaluate the potential effect of the intervention on airway resistance and reactance, particularly the potential to improve lung mechanics and detect subtle changes in airway function in individuals with impaired or fluctuating respiratory function.

Laboratory tests

时间窗: Baseline and after 6 weeks (post-intervention)

inflammatory cytokine profile and CRP (IL-1β, IL-6, IL-8, IL-10, IL-12, TNF-α, CRP), lipid profile. Systemic inflammation parameter and lipid profile, this measurement is to evaluate the potential effect of the intervention on inflammatory status, particularly the potential to modify circulating cytokine levels and acute-phase response markers. Laboratory analyses will be performed by qualified diagnostic personnel. Blood samples will be collected into plasma separator tubes (containing lithium-heparin gel), centrifuged, and analyzed. The following parameters will be used for the assessment: interlukin-1β, interlukin-6, interlukin-8, interlukin-10, interlukin-12, tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP), lipid profile (HDL, LDL, TG). The study will be performed once in all study participants and a second time in those undergoing inspiratory muscle training to assess changes in systemic inflammation associated with the intervention.

次要结局

  • Body Composition (Bioelectrical Impedance Analysis, BIA)(Baseline and after 6 weeks (post-intervention))
  • World Health Organization - Quality of Life - BREF (WHOQOL-BREF)(Baseline and after 6 weeks (post-intervention))
  • International Physical Activity Questionnaire - short version (IPAQ - short version)(Baseline and after 6 weeks (post-intervention))

研究者

发起方
Wroclaw University of Health and Sport Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paulina Okrzymowska

Principal Investigator

Wroclaw University of Health and Sport Sciences

研究点 (2)

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