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

NCT ID: NCT05239819

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-12-01

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.

Detailed Description

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Conditions

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Inspiratory Muscle Training Postoperative Pulmonary Complications Respiratory Muscle Function Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study population will be randomized and separated in two groups, Intervention and Usual care group.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type 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

Usual care group

The Usual care group will receive regulated education.

Group Type ACTIVE_COMPARATOR

Regulated care and education

Intervention Type BEHAVIORAL

Regulated care and education will be applied

Interventions

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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

Intervention Type BEHAVIORAL

Regulated care and education

Regulated care and education will be applied

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Kun-Ling Tsai

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Cheng Kung University

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 35942800 (View on PubMed)

Other Identifiers

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B-BR-108-012

Identifier Type: -

Identifier Source: org_study_id

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