search
Back to results

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

Primary Purpose

Inspiratory Muscle Training, Postoperative Pulmonary Complications, Respiratory Muscle Function

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Inspiratory muscle training
Regulated care and education
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inspiratory Muscle Training focused on measuring inspiratory muscle training, postoperative pulmonary complications, respiratory muscle function, abdominal surgery

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng Kung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Usual care group

Arm Description

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.

The Usual care group will receive regulated education.

Outcomes

Primary Outcome Measures

Postoperative Pulmonary complications rate
According to the definition of PPCs on European Perioperative Clinical Outcome 2015
Respiratory muscles strength
MIP and MEP are done by measuring the upper airway pressure
Diaphragm mobilit
Diaphragm ultrasonography

Secondary Outcome Measures

Quality of life score
The World Health Organization Quality of Life Briefing

Full Information

First Posted
February 4, 2022
Last Updated
February 4, 2022
Sponsor
National Cheng Kung University
search

1. Study Identification

Unique Protocol Identification Number
NCT05239819
Brief Title
The Cardiopulmonary Effects and Diaphragm Function of Complete Inspiratory Muscle Training in Patients With Upper Abdominal Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inspiratory Muscle Training, Postoperative Pulmonary Complications, Respiratory Muscle Function, Abdominal Surgery
Keywords
inspiratory muscle training, postoperative pulmonary complications, respiratory muscle function, abdominal surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study population will be randomized and separated in two groups, Intervention and Usual care group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
The Usual care group will receive regulated education.
Intervention Type
Behavioral
Intervention Name(s)
Inspiratory muscle training
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Regulated care and education
Intervention Description
Regulated care and education will be applied
Primary Outcome Measure Information:
Title
Postoperative Pulmonary complications rate
Description
According to the definition of PPCs on European Perioperative Clinical Outcome 2015
Time Frame
Change from baseline (0 week) to follow up (4 weeks)
Title
Respiratory muscles strength
Description
MIP and MEP are done by measuring the upper airway pressure
Time Frame
Change from baseline (0 week) to follow up (4 weeks)
Title
Diaphragm mobilit
Description
Diaphragm ultrasonography
Time Frame
Change from baseline (0 week) to follow up (4 weeks)
Secondary Outcome Measure Information:
Title
Quality of life score
Description
The World Health Organization Quality of Life Briefing
Time Frame
Change from baseline (0 week) to follow up (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD sharing plan will be decided after summarized data being published
Citations:
PubMed Identifier
35942800
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs