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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Inspiratory Muscle Training, Postoperative Pulmonary Complications, Respiratory Muscle Function, Abdominal Surgery

Intervention / Treatment
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* Behavioral: Inspiratory muscle training
* Behavioral: Regulated care and education


Participation Criteria
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Eligibility Criteria
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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 4) unable to follow exercise protocol 5) severe organ failure

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study population will be randomized and separated in two groups, Intervention and Usual care group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>We conducted a fully engaged inspiratory muscle training (IMT) program. The exercise group received the intervention threshold IMT from preoperative to postoperative undergoing upper abdominal surgery. The IMT was started before 3 weeks of operation and surveyed in the followed 4 weeks. | Behavioral: Inspiratory muscle training<br>* 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<br>|
| Active Comparator: Usual care group<br>The Usual care group will receive regulated education. | Behavioral: Regulated care and education<br>* Regulated care and education will be applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pulmonary complications rate | According to the definition of PPCs on European Perioperative Clinical Outcome 2015 | Change from baseline (0 week) to follow up (4 weeks) | 
| Respiratory muscles strength | MIP and MEP are done by measuring the upper airway pressure | Change from baseline (0 week) to follow up (4 weeks) | 
| Diaphragm mobilit | Diaphragm ultrasonography | Change from baseline (0 week) to follow up (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | The World Health Organization Quality of Life Briefing | Change from baseline (0 week) to follow up (4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inspiratory muscle training, postoperative pulmonary complications, respiratory muscle function, abdominal surgery