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临床试验/NCT07168733
NCT07168733已完成不适用

Effect of Inspiratory Muscle Training on Diaphragm and Ab-dominal Wall Muscle Thickness With Fatty Liver Density in Elderly Women: A Randomized Controlled Trial

Gümüşhane Universıty1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年6月5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
26
试验地点
1
主要终点
pre-training

研究概览

简要总结

Background: Post-menopausal estrogen decline is considered a contributing factor to sarcopenia, and inspiratory muscle training (IMT) may provide benefits in this demo-graphic. This study examined the impact of a four-week IMT program on diaphragm thickness, abdominal wall muscle thickness (AWMT; transversus abdominis, internal oblique, and external oblique), and liver fat percentage in healthy elderly women. Methods: Twenty-six women aged 60-80 years were randomly assigned to an IMT group (n = 13) or a control group (n = 13). The IMT group used the PowerBreathe® Classic device at 40% of maximal inspiratory pressure (MIP), with weekly increments of 10%. Training was performed twice daily, five days per week, with 30 breathing cycles per session (60 per day). The control group maintained their usual routines. AWMT, diaphragm thickness (DT), and fatty liver density (FLD) were measured by a radiologist before and after the intervention.

详细描述

  1. Introduction The aging process leads to various impairments in multiple physiological systems, including the musculoskeletal and respiratory systems. One of the primary consequences of this process is the decline in overall muscle strength, which directly affects an individual's functional capacity and ability to perform daily living activities. Although this reduction in muscle mass and strength is not directly associated with any specific disease, it becomes more pronounced in elderly adults with health conditions that limit mobility. Respiratory muscle weakness alone is considered a significant limiting factor for physical fitness and may lead to clinical outcomes, including impaired lung function, reduced muscle strength, and dyspnea.

Previous studies have reported that physical exercise provides a wide range of benefits for elderly adults, including improvements in functional capacity, reductions in infection rates, enhanced cardiovascular fitness, improved muscle fiber quality, and overall enhancements in quality of life. Aerobic exercise has been shown to exert systemic benefits, including improvements in respiratory muscle strength. Moreover, regular physical activity induces both local and systemic anti-inflammatory responses, offering protective effects against age-related chronic inflammatory pathologies (Silva et al., 2011, Can et al., 2019).

In this context, improving respiratory function through targeted interventions is vital for maintaining independence and decreasing healthcare burdens in aging populations. In recent years, IMT has gained increasing attention due to its dual role in enhancing athletic performance and improving functional capacity in elderly adults. IMT is a resistance training approach involving moderate-intensity respiratory loading, typically at 40-60% of maximal inspiratory pressure. It is performed over short durations while yielding significant improvements in muscle strength and endurance. Home-based protocols generally consist of breathing sessions conducted twice daily, five to seven days per week.

The practicality and safety of these home-based programs make IMT particularly suitable for elderly populations, including those with mobility restrictions. IMT has been reported to lower blood pressure in elderly adults with systolic hypertension , improve cardiac autonomic function, reduce sympathetic overactivity, and enhance vagal tone at rest in individuals with obstructive sleep apnea. Furthermore, IMT has been identified as a non-pharmacological intervention that enhances diaphragm function, supports postural balance, increases trunk stability, facilitates venous return, and ultimately reduces the risk of falls.

With advancing age, several age-related changes occur in the respiratory system, including reduced chest wall compliance, decreased elastic recoil of the lung parenchyma, diminished respiratory muscle strength, and a blunted response to gas exchange abnormalities. These alterations are associated with decreased exercise capacity, impaired walking performance, and reduced quality of life in elderly adults. The decline in respiratory muscle function renders elderly individuals more vulnerable to disease and disability; therefore, strengthening these muscle groups is crucial for reducing the risks of morbidity and mortality. Despite this, respiratory-specific exercise strategies, such as IMT, remain underutilized in geriatric health promotion efforts.

研究设计

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

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •were defined as women aged 60-80 years (post-menopausal), who were independent in activities of daily living,
  • •demonstrated adequate cognitive function to follow instructions,
  • •had no musculoskeletal injury within the previous six months,
  • •were non-smokers,
  • •had routine thoracic or abdominal CT images obtained for clinical indications and used in this study.

排除标准

  • •included having uncontrolled cardiovascular or pulmonary disease such as heart failure or COPD/asthma exacerbation,
  • •uncontrolled hypertension, diagnosed chronic liver disease,
  • •acute respiratory infection within the last four weeks,
  • •participation in structured respiratory or resistance training within the last six months,
  • •recent thoracoabdominal surgery or hernia, use of medications known to affect muscle or liver metabolism such as systemic corticosteroids, anabolic agents, or hepatotoxic drugs,
  • •severe orthopedic or neurological conditions limiting mobility, or refusal to participate.

研究组 & 干预措施

Inspiratory muscle training

Experimental

Inspiratory muscle training group (IMT n:13) IMT was performed using the POWERbreathe® device (POWER® Breathe Classic, IMT Technologies Ltd., Birmingham, UK). The POWERbreathe® device is a pressure-threshold IMT device that provides resistance during inhalation. The user breathes in through a mouthpiece against an adjustable spring-loaded valve, which opens only when the inspiratory pressure exceeds the set threshold, thereby strengthening the inspiratory muscles over time (Kowalski & Klusiewicz, 2023). Following a one-week familiarization period, the IMT protocol was performed twice daily (morning and evening), five days per week, for four weeks. Each session consisted of 30 breathing cycles, resulting in a total of 60 cycles per day. Prior to training, the device resistance was calibrated to 40% of each participant's maximal inspiratory pressure (MIP), as reported by Çelikel et al. (2025) to promote increases in muscle size and thickness. MIP was reassessed weekly and resistance was

干预措施: Inspiratory muscle training (Device)

Inspiratory muscle training

Experimental

Inspiratory muscle training group (IMT n:13) IMT was performed using the POWERbreathe® device (POWER® Breathe Classic, IMT Technologies Ltd., Birmingham, UK). The POWERbreathe® device is a pressure-threshold IMT device that provides resistance during inhalation. The user breathes in through a mouthpiece against an adjustable spring-loaded valve, which opens only when the inspiratory pressure exceeds the set threshold, thereby strengthening the inspiratory muscles over time (Kowalski & Klusiewicz, 2023). Following a one-week familiarization period, the IMT protocol was performed twice daily (morning and evening), five days per week, for four weeks. Each session consisted of 30 breathing cycles, resulting in a total of 60 cycles per day. Prior to training, the device resistance was calibrated to 40% of each participant's maximal inspiratory pressure (MIP), as reported by Çelikel et al. (2025) to promote increases in muscle size and thickness. MIP was reassessed weekly and resistance was

干预措施: Control (Other)

CONTROL

No Intervention

The research group (Control Group (CG) (n:13)

结局指标

主要结局

pre-training

时间窗: 4 week

Assessments were performed for all participants in both groups 4 weeks before and after treatment. These parameters were assessed using pre- and post-test measurements and compared between the IMT group and the control group Diaphragm Thickness (DT) * Mid-diaphragm thickness (MDT) * Posterior diaphragm thickness (PDT)

pre-training

时间窗: 4 Week

Assessments were performed for all participants in both groups 4 weeks before and after treatment. These parameters were assessed using pre- and post-test measurements and compared between the IMT group and the control group -Fatty Liver Density (FLD)

次要结局

未报告次要终点

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

ASSOC. PROF.

Gümüşhane Universıty

研究点 (1)

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