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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Surgery; Inspiratory Muscle Training; Postoperative Pulmonary Complications; Respiratory Muscle Function
• Intervention / Treatment: Behavioral: Inspiratory muscle training; Behavioral: Regulated care and education

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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
Active Comparator: Usual care group; The Usual care group will receive regulated education.	Behavioral: Regulated care and education; Regulated care and education will be applied

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: National Cheng Kung University

Publications and helpful links

General Publications

• Huang YT, Lin YJ, Hung CH, Cheng HC, Yang HL, Kuo YL, Chu PM, Tsai YF, Tsai KL. 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. Ann Med. 2022 Dec;54(1):2222-2232. doi: 10.1080/07853890.2022.2106511.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: inspiratory muscle training; abdominal surgery; postoperative pulmonary complications; respiratory muscle function
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: B-BR-108-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing plan will be decided after summarized data being published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No