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OpenTrials
Completed

NCT Number: NCT05239819

The Cardiopulmonary Effects and Diaphragm Function of Complete Inspiratory Muscle Training in Patients With Upper Abdominal Surgery

Upper abdominal surgical treatment may have reduced respiratory muscle function and mucociliary clearance, which might be a consequence of postoperative pulmonary complications (PPCs). The threshold inspiratory muscle training (IMT) may serve as an effective modality to improve respiratory muscle strength and endurance in patients. However, whether this training could help patients with upper abdominal surgery remain to be determined.

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Key information

Conditions

Inspiratory Muscle Training Abdominal Surgery Postoperative Pulmonary Complications Respiratory Muscle Function

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 701, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≧20 years old with upper abdominal surgery,
  • American Society of Anesthesiologists; ASA) I-IV
  • body Mass Index; BMI≥ 18
  • able to follow exercise protocol. T

Exclusion criteria

  • history of prior abdominal surgery
  • high risk of exercise contraindications (e.g. severe cardiac or cardiovascular disease), 3) American Society of Anesthesiologists; ASA) V-IV
  • unable to follow exercise protocol 5) severe organ failure

Treatment and study plan

Inspiratory Muscle Training

Behavioral

The initial training intensity of the preoperative threshold IMT trainer (DofinTM, Breathing Strength Builder, Taiwan) was moderate to high intensity (≥50% of MIP), which was according to the patient's baseline level and increased by 5-10% per week. The frequency is 25-30 minutes each time, twice a day and five days per week for at least two weeks. The participants would receive at least 10 times training sessions before surgery

Regulated care and education

Behavioral

Regulated care and education will be applied

Primary outcomes

  1. Postoperative Pulmonary complications rate

    Time frame: Change from baseline (0 week) to follow up (4 weeks)

    According to the definition of PPCs on European Perioperative Clinical Outcome 2015

  2. Respiratory muscles strength

    Time frame: Change from baseline (0 week) to follow up (4 weeks)

    MIP and MEP are done by measuring the upper airway pressure

  3. Diaphragm mobilit

    Time frame: Change from baseline (0 week) to follow up (4 weeks)

    Diaphragm ultrasonography

Secondary outcomes

  1. Quality of life score

    Time frame: Change from baseline (0 week) to follow up (4 weeks)

    The World Health Organization Quality of Life Briefing

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study title

The Fully Engaged Inspiratory Muscle Training Reduces Postoperative Pulmonary Complications Rate and Increased Respiratory Muscle Function in Patients With Upper Abdominal Surgery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2022
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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