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

Abdominal Surgery Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05239819
• Other study ID #: B-BR-108-012
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2022
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. ?20 years old with upper abdominal surgery,

2. American Society of Anesthesiologists; ASA) I-IV

3. body Mass Index; BMI= 18

4. able to follow exercise protocol. T

Exclusion Criteria:

1. history of prior abdominal surgery

2. 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

Related Conditions & MeSH terms

• Abdominal Surgery
• Inspiratory Muscle Training
• Postoperative Pulmonary Complications
• Respiratory Aspiration
• Respiratory Muscle Function

Intervention

Behavioral:
• Inspiratory muscle training
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
Regulated care and education will be applied

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Respiratory muscles strength	MIP and MEP are done by measuring the upper airway pressure	Change from baseline (0 week) to follow up (4 weeks)
Primary	Diaphragm mobilit	Diaphragm ultrasonography	Change from baseline (0 week) to follow up (4 weeks)
Secondary	Quality of life score	The World Health Organization Quality of Life Briefing	Change from baseline (0 week) to follow up (4 weeks)