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

NCT05239819 | Completed

• 1 other identifier: B-BR-108-012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inspiratory Muscle Training; Postoperative Pulmonary Complications; Respiratory Muscle Function; Abdominal Surgery

Keywords

inspiratory muscle training; postoperative pulmonary complications; respiratory muscle function; abdominal surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Quality of life score

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Usual care group

ACTIVE COMPARATOR

The Usual care group will receive regulated education.

Behavioral: Regulated care and education

Interventions

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

Intervention group

Regulated care and education BEHAVIORAL

Regulated care and education will be applied

Usual care group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≧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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35942800 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study population will be randomized and separated in two groups, Intervention and Usual care group.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)