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临床试验/NCT07394127
NCT07394127已完成不适用

A Community-Based Swimming and Inspiratory Muscle Training Intervention to Promote Physical Activity and Asthma Control in Children With Mild Asthma

Gümüşhane Universıty1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Maximal Inspiratory Pressure (MIP)

研究概览

简要总结

This randomized controlled trial investigated the effects of adding inspiratory muscle training (IMT) to a structured swimming program on pulmonary function, respiratory muscle strength, ventilatory capacity, perceived exertion, and asthma control in children with mild persistent asthma. Thirty children aged 8-11 years were randomly assigned to either a swimming plus IMT group or a swimming-only group. Both groups participated in a supervised 4-week swimming program, while the experimental group additionally performed IMT twice daily. Pulmonary function tests, respiratory muscle strength, and Childhood Asthma Control Test (C-ACT) scores were assessed before and after the intervention.

详细描述

Asthma-related airway obstruction and respiratory muscle dysfunction may limit exercise tolerance and disease control in children. Swimming is considered a safe and beneficial exercise modality for pediatric asthma due to its humid environment and controlled breathing patterns. Inspiratory muscle training specifically targets respiratory muscle weakness and may further enhance pulmonary adaptations. This parallel-group randomized controlled trial examined whether combining IMT with swimming training yields superior improvements in lung function, respiratory muscle strength, ventilatory capacity, perceived exertion, and asthma control compared with swimming training alone. The intervention lasted four weeks, with objective pulmonary and respiratory muscle assessments conducted pre- and post-intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 8-11 years
  • •Clinically diagnosed mild persistent asthma according to GINA guidelines
  • •Baseline FEV₁ ≥ 80% predicted
  • •Stable asthma treatment for at least 4 weeks
  • •Written informed consent from parents or guardians

排除标准

  • •Mild intermittent, moderate, or severe persistent asthma
  • •Acute asthma exacerbation during the study
  • •Other chronic respiratory, cardiovascular, or neuromuscular diseases
  • •Recent upper respiratory tract infection
  • •Use of medications affecting pulmonary function other than standard asthma therapy

研究组 & 干预措施

Swimming Training Only (Control Group)

Other

Participants completed a supervised swimming training program for 4 weeks, consisting of three 60-minute sessions per week. Sessions included warm-up, main swimming exercises, and cool-down breathing exercises. Exercise intensity was maintained at approximately 65% of maximal heart rate.

干预措施: Swimming Training Only (Control Group) (Other)

Swimming + Inspiratory Muscle Training (Experimental Group)

Experimental

Participants completed the same swimming training program as the control group. In addition, inspiratory muscle training was performed using a threshold pressure-loading device. IMT was conducted twice daily, starting at 30% of maximal inspiratory pressure and progressively increased by 5% weekly, over a 4-week period.

干预措施: Swimming + Inspiratory Muscle Training (Experimental Group) (Other)

Swimming Training Only (Control Group)

Other

Participants completed a supervised swimming training program for 4 weeks, consisting of three 60-minute sessions per week. Sessions included warm-up, main swimming exercises, and cool-down breathing exercises. Exercise intensity was maintained at approximately 65% of maximal heart rate.

干预措施: Swimming + Inspiratory Muscle Training (Experimental Group) (Other)

Swimming + Inspiratory Muscle Training (Experimental Group)

Experimental

Participants completed the same swimming training program as the control group. In addition, inspiratory muscle training was performed using a threshold pressure-loading device. IMT was conducted twice daily, starting at 30% of maximal inspiratory pressure and progressively increased by 5% weekly, over a 4-week period.

干预措施: Swimming Training Only (Control Group) (Other)

结局指标

主要结局

Maximal Inspiratory Pressure (MIP)

时间窗: 4 weeks

Measured using a handheld respiratory pressure device to assess inspiratory muscle strength.

Forced Expiratory Volume in 1 Second (FEV₁)

时间窗: 4 weeks

Assessed via spirometry to evaluate pulmonary function. Forced expiratory volume in one second (FEV₁) was measured using the spirometry method to assess lung function. FEV₁ values were reported as a percentage of the predicted value (% predicted) based on reference values. While there is no theoretical minimum or maximum limit for the measurement, higher FEV₁ values indicate better pulmonary function.

Childhood Asthma Control Test (C-ACT) Score

时间窗: 4 weeks

Validated questionnaire assessing asthma symptom control in children. The Childhood Asthma Control Test (C-ACT) is a self-report questionnaire used to assess the level of asthma symptom control in children over the past 4 weeks, with proven validity and reliability. The total scale score ranges from 0 to 27, with higher scores indicating better asthma control.

次要结局

  • Rating of Perceived Exertion (Borg Scale)(4 week)
  • Maximum Voluntary Ventilation (MVV)(4 week)
  • Peak Expiratory Flow (PEF)(4 week)
  • Forced Vital Capacity (FVC)(4 week)

研究者

发起方
Gümüşhane Universıty
申办方类型
Other
责任方
Principal Investigator
主要研究者

Coşkun YILMAZ

Director

Gümüşhane Universıty

研究点 (1)

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