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临床试验/NCT05668975
NCT05668975进行中(未招募)不适用

The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia

Istanbul University2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2022年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Maximal Inspiratory Pressure

研究概览

简要总结

Sarcopenia, according to EWGSOP2(European Working Group on Sarcopenia in Older People-2019), is a progressive and generalised skeletal muscle disorder that is associated with increased likelihood of adverse outcomes including falls, fractures, physical disability, and mortality. Changes in muscle strength and muscle mass that occur with aging are not only limited to the skeletal muscles surrounding the axial and appendicular skeleton, but also occur in the respiratory muscles. With aging, respiratory muscle strength decreases, muscle mass decreases, and respiratory functions decline. In sarcopenic individuals; maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) and diaphragm muscle thickness values were found to be significantly lower.

It is known that exercise is the most effective and valid way to treat sarcopenia. Considering the positive effects of IMT (Inspiratory Muscle Training) on both respiratory and physical parameters in the elderly population, we think that these changes can also be observed in sarcopenic individuals. Therefore, the aim of this study is to investigate the effects of inspiratory muscle training on diaphragm thickness, inspiratory muscle strength, and exercise capacity in sarcopenic individuals.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • People who are diagnosed with confirmed sarcopenia or severe sarcopenia according to EWGSOP2 (European Working Group on Sarcopenia in Older People-2019)
  • Getting a score of 24 or higher on the mini-mental state test

排除标准

  • Presence of chronic lung and/or cardiovascular disease
  • Presence of severe orthopedic diseases which may affect participants' mobility
  • Presence of uncontrollable hypertension and/or diabetes.

结局指标

主要结局

Maximal Inspiratory Pressure

时间窗: Eight weeks

Maximal inspiratory pressure (MIP) will be measured using an electronic mouth pressure device (Micro RPM). At least 3 repetitions will be performed and the measurement will be repeated until there is less than a 5% difference between the best and the second-best measurement.

Diaphragm Thickness Measurement at Total Lung Capacity (TLC)

时间窗: Eight weeks

Diaphragm thickness measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. Diaphragm thickness will be measured as the vertical distance between the pleural and peritoneal layer at Total Lung Capacity (TLC). Measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 3 times and the average value will be calculated. The value will be expressed in millimeters (mm).

Diaphragm Elastography Measurement at Total Lung Capacity (TLC)

时间窗: Eight weeks

Diaphragm elastography measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. The measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 2 times and the average value will be calculated. The value will be expressed in kPa (kilopascal).

Diaphragm Thickness Measurement at Quiet Breathing

时间窗: Eight weeks

Diaphragm thickness measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. Diaphragm thickness will be measured as the vertical distance between the pleural and peritoneal layer at quiet breathing. Measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 3 times and the average value will be calculated. The value will be expressed in millimeters (mm).

Diaphragm Elastography Measurement at Quiet Breathing

时间窗: Eight weeks

Diaphragm elastography measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. The measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 2 times and the average value will be calculated. The value will be expressed in kPa (kilopascal).

Exercise Capacity Measurement

时间窗: Eight weeks

The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT).

Diaphragm Thickness Measurement at Functional Residual Capacity (FRC)

时间窗: Eight weeks

Diaphragm thickness measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. Diaphragm thickness will be measured as the vertical distance between the pleural and peritoneal layer at Functional Residual Capacity \[FRC\]. Measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 3 times and the average value will be calculated. The value will be expressed in millimeters (mm).

Diaphragm Elastography Measurement at Functional Residual Capacity (FRC)

时间窗: Eight weeks

Diaphragm elastography measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. The measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 2 times and the average value will be calculated. The value will be expressed in kPa (kilopascal).

次要结局

  • Pulmonary Function Test [Peak Expiratory Flow Rate (PEFR)](Eight weeks)
  • Pulmonary Function Test [Forced expiratory flow 25-75 (FEF25-75%)](Eight weeks)
  • Assesment of Quality of Life(Eight weeks)
  • Pulmonary Function Test [Forced Vital Capacity (FVC)](Eight weeks)
  • Pulmonary Function Test [Forced Expiratory Volume in the first second (FEV1)](Eight weeks)

研究者

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

Eren Özdoğan

Physiotherapist, MSc Student in Exercise Physiology, Istanbul University

Istanbul University

研究点 (2)

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