このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Respiratory Muscle Training in the ICU: IMT vs Diaphragmatic NMES

2026年5月2日 更新者:Ali Yalman

Comparing the Effects of Inspiratory Muscle Training and Diaphragmatic Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients: A Randomized Controlled Trial

This study aimed to compare the effects of Inspiratory Muscle Training (IMT) and Diaphragmatic Neuromuscular Electrical Stimulation (NMES) on inspiratory muscle strength, mechanical ventilator parameters, and functional levels in intubated intensive care unit (ICU) patients. Thirty-two intubated patients were divided into two groups: the IMT group and the NMES group. In the IMT group, IMT was administered twice a day in addition to routine physiotherapy. In the NMES group, electrical stimulation was applied to the diaphragm muscle for 40 minutes in addition to routine physiotherapy. The primary outcomes of the study are inspiratory muscle strength and physical function level. The secondary outcomes are mechanical ventilator parameters, extubation time, and length of hospital stay.

調査の概要

詳細な説明

This randomized study aimed to compare the effects of Inspiratory Muscle Training (IMT) and Neuromuscular Electrical Stimulation (NMES) on inspiratory muscle strength, mechanical ventilator parameters, and functional levels in intensive care unit (ICU) patients.

A total of 32 mechanically ventilated patients were randomly assigned to either an IMT group (n=16) or an NMES group (n=16). In addition to routine ICU physiotherapy, the IMT group received inspiratory muscle training using Philips Respironics Threshold IMT devices, while the NMES group received stimulation on the diaphragm with Aussie current using surface electrodes.

研究の種類

介入

入学 (実際)

32

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria

  • Being intubated
  • Conscious state
  • Ability to trigger mechanical ventilation
  • Capability to execute at least one motor command

Exclusion Criteria

  • Any neurological or orthopedic diagnosis or deficits
  • Inability to cooperate with the physiotherapist
  • Hemodynamic instability despite medical treatment
  • Excessive secretions requiring aspiration more than once per hour.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:Inspiratory Muscle Training (IMT)
As a result of randomization, the IMT group consisted of 16 participants with a mean age of 70 ± 9.57 years. IMT was administered to the participants twice a day following routine physiotherapy, which included breathing exercises and mobilization.
Routine ICU physiotherapy includes: conventional chest physiotherapy, consisting of diaphragmatic breathing, thoracic expansion exercises, postural drainage, cough training, and in-bed ROM exercises and mobilization. In addition to routine ICU physiotherapy, patients received IMT twice daily with Threshold IMT devices (Respironics, New Jersey, Inc., NJ, USA). The IMT program started at 30% of pretreatment Pimax and was increased by 2H2O daily according to patients' tolerance. A total of 3 sets of 8 repetitions were applied.
実験的:Neuromuscular electric stimulation (NMES)
As a result of randomization, the NMES group consisted of 16 participants with a mean age of 65.31 ± 8.38 years. Following routine intensive care physiotherapy, which included breathing exercises and mobilization, NMES was applied to the diaphragm muscle for 40 minutes.
Routine ICU physiotherapy includes: conventional chest physiotherapy, consisting of diaphragmatic breathing, thoracic expansion exercises, postural drainage, cough training, and in-bed ROM exercises and mobilization. In addition to routine ICU physiotherapy, patients received NMES on the diaphragm with surface electrodes. Electrodes were placed at four channels with two electrodes on both sides of the xiphoid at the level of the intercostal space of the 7th and 8th ribs, superiorly and inferiorly. In addition, two electrodes with two channels were placed superiorly and inferiorly at the midaxillary level of the intercostal space of the 7th and 8th ribs. A total of 4 channels and 8 electrodes were used with modified burst series biphasic current 30 Hz (Aussie current).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Inspiratory muscle strength
時間枠:Baseline, 1 hour before extubation, 1 hour before discharge
Inspiratory muscle strength (Pimax) was assessed by a desktop spirometer with Pimax module (Pony Fx, COSMED, Rome, Italy). A catheter mount piece was placed in front of the pressure measurement part of spirometer to perform the measurement in intubated participants. Participants were encouraged throughout the measurements to achieve maximum strength and coordination. The measurements were repeated three times, and the average of these values was recorded. To prevent respiratory muscle fatigue, at least a one-minute break was provided between trials. Results were reported in cmH2O units.
Baseline, 1 hour before extubation, 1 hour before discharge
Physical Functions
時間枠:Baseline, 1 hour before discharge
Physical function levels of patients were evaluated by Physical Function Intensive Care Unit Test-scored (PFIT-s). Physical Function Intensive Care Unit Test-scored has 4 test components; shoulder flexion strength, knee extension strength, sit to stand assistance, step cadence. Before the test, the participant was expected to correctly answer 2 of 5 questions to assessing the cooperation. Participants' vital signs were noted before and after the test. Participants are scored on a total scale ranging from 0 to 10. A score of 0 signifies total dependence and poor muscle strength, whereas a score of 10 represents functional independence and optimal muscle strength.
Baseline, 1 hour before discharge

二次結果の測定

結果測定
メジャーの説明
時間枠
Mechanical Ventilatory Parameters - Tidal Volumes
時間枠:Baseline, 1 hour before extubation
Respitatory parameters were assessed by mechanic ventilator (The Engstrom Carestation, GE Health Care 2016). The test procedure; device was switched to CPAP mode, Psupport was set to 10 cmH2O and PEEP was set to 5 cmH2O to overcome the physiological resistance of the ventilator circuit. The patient was instructed to take deep breaths for one minute. As the measurements required patient motivation and coordination, the tests were conducted by providing appropriate verbal commands. Inspiratory tidal volume (TVi) and expiratory tidal volume (TVe) were recorded in milliliters (ml).
Baseline, 1 hour before extubation
Mechanical Ventilatory Parameter - Minute Ventilation
時間枠:Baseline, 1 hour before extubation
Respitatory parameters were assessed by mechanic ventilator (The Engstrom Carestation, GE Health Care 2016). The test procedure; device was switched to CPAP mode, Psupport was set to 10 cmH2O and PEEP was set to 5 cmH2O to overcome the physiological resistance of the ventilator circuit.The patient was instructed to perform deep breathing for a period of one minute. Since the measurement required patient motivation and coordination, the tests were conducted by providing appropriate verbal commands. Minute ventilation was recorded in liters per minute (L/min)
Baseline, 1 hour before extubation
Length of time intubated
時間枠:12 hours after extubation
The duration of intubation for the participants was reported in days.
12 hours after extubation
Hospital stay length
時間枠:2 hours after discharge
The duration of hospital stay was reported in days
2 hours after discharge

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年3月5日

一次修了 (実際)

2021年10月20日

研究の完了 (実際)

2021年11月23日

試験登録日

最初に提出

2026年4月11日

QC基準を満たした最初の提出物

2026年5月2日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月6日

QC基準を満たした最後の更新が送信されました

2026年5月2日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 60116787-020/46004

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する