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临床试验/NCT07595341
NCT07595341Enrolling By Invitation不适用

Effects of Inspiratory Training on Respiratory Function, Diaphragmatic Structure, and Cardiac Response in Healthy Adults During Aquatic Exercise.

Universidad Rey Juan Carlos1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
34
试验地点
1
主要终点
Sport performance

研究概览

简要总结

Introduction:

The diaphragm is the primary inspiratory muscle and plays a key role in ventilation, trunk stability, and exercise efficiency. Its dysfunction is associated with early fatigue, increased respiratory work, and reduced performance. Inspiratory muscle training (IMT) has been shown to improve respiratory function and exercise tolerance. Swimming, due to its specific characteristics, imposes an additional demand on the respiratory muscles.

Objective:

To evaluate the effects of an IMT program on diaphragmatic function, respiratory variables, cardiorespiratory response, and performance in swimmers.

Methods:

A randomized, parallel, double-blind clinical trial with 34 swimmers. The experimental group will perform an 8-week IMT program with progressive loads, while the control group will use a sham device without resistance. Diaphragmatic function will be assessed using ultrasound (thickness and excursion), along with respiratory variables (MIP, FEV₁, MEP, FVC), cardiovascular variables (heart rate, HRV), metabolic variables (lactate), and performance (100 m test).

Expected results:

IMT is expected to improve diaphragmatic function, increase inspiratory muscle strength, enhance ventilatory efficiency, and reduce respiratory fatigue, leading to improvements in performance and physiological responses to exercise.

Conclusion:

IMT could be an effective strategy to enhance respiratory function and swimming performance. This study provides a novel approach by incorporating ultrasound assessment of the diaphragm in an aquatic exercise context.

详细描述

Diaphragm

The diaphragm is the primary muscle of inspiration. It is a dome-shaped skeletal muscle located between the thoracic and abdominal cavities. Its contraction increases thoracic volume, allowing air to enter the lungs. Beyond respiration, it contributes to core stability and postural control during movement and exercise.

Inspiratory Muscle Training (IMT)

IMT is a training method that involves breathing against a resistive load to strengthen the inspiratory muscles, mainly the diaphragm and accessory muscles. It is used to improve respiratory strength, endurance, and ventilatory efficiency, especially in athletes and clinical populations.

Respiratory function

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants of both sexes, aged over 18 years.
  • Minimum swimming training frequency of at least two sessions per week, with a minimum duration of 30 minutes per session, consistently maintained over the last three months.

排除标准

  • Current or previous diagnosis of respiratory diseases.
  • Musculoskeletal injuries limiting the ability to perform a 100-meter swimming test.
  • Participation in inspiratory muscle training programs within the last six months.

研究组 & 干预措施

Inspiratory training

Active Comparator

The experimental group will perform an eight-week home-based training program using the POWERbreathe EX1-MR device, individually calibrated according to MIP. Participants will complete 30 deep inspirations per session, twice daily, seven days per week, with progressive intensities: 30% of initial MIP during weeks 1-2, 50% of the new MIP during weeks 3-4, 60% during weeks 5-6, and 70% of MIP during weeks 7-8, with the aim of familiarizing participants with the device and progressively adapting the diaphragm to increasing loads.

干预措施: Inspiratory training (Device)

Placebo

Placebo Comparator

The control group will use the same device without resistance, maintaining the same breathing frequency and volume in order to control for the placebo effect.

干预措施: Placebo (Device)

结局指标

主要结局

Sport performance

时间窗: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

Total time and split times for completing 100 m freestyle.

Maximal inspiratory pressure.

时间窗: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

Inspiratory variables: Inspiratory muscle strength was assessed by measuring MIP using the POWERbreathe Smart Adaptor device. The participant was seated and used a mouthpiece with a leak hole to minimize activation of the orofacial musculature. The procedure consisted of a maximal expiration to residual volume, followed by a maximal inspiration sustained against the device for at least 2 seconds. Three attempts were performed with rest periods of at least 1 minute, and the highest value was selected.

Maximal espiratory pressure.

时间窗: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

Expiratory variables: Pulmonary function was assessed using forced spirometry, recording FEV₁, MEP, and FVC with the MIR Spirobank Oxi Portable Spirometer device. For a manoeuvre to be acceptable, the subject had to perform a maximal inspiration followed by a rapid and continuous forced expiration, without coughing during the first second and with a smooth flow-volume curve, without leaks. The expiration had to last at least 6 seconds or until a volume plateau was reached. Manoeuvres with interruptions, false efforts, or closed glottis were discarded. Three acceptable manoeuvres were performed, and results were considered valid when the two best FEV₁ and FVC values differed by less than 150 mL. If this variability criterion was not met, additional attempts were performed until reproducible results were obtained.

次要结局

  • lactate(This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.)
  • Perceived exertion.(This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.)
  • Dysnea(This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.)
  • Heart rate.(This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.)
  • Diaphragmatic excursion(This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.)
  • Diaphragmatic thickening(This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Agustin Velazquez Córdoba

Principal Investigator

Universidad Rey Juan Carlos

研究点 (1)

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