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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05239819
Enrollment
30
Registered
2022-02-15
Start date
2019-04-01
Completion date
2020-12-01
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALInspiratory 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

BEHAVIORALRegulated care and education

Regulated care and education will be applied

Sponsors

National Cheng Kung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pulmonary complications rateChange from baseline (0 week) to follow up (4 weeks)According to the definition of PPCs on European Perioperative Clinical Outcome 2015
Respiratory muscles strengthChange from baseline (0 week) to follow up (4 weeks)MIP and MEP are done by measuring the upper airway pressure
Diaphragm mobilitChange from baseline (0 week) to follow up (4 weeks)Diaphragm ultrasonography

Secondary

MeasureTime frameDescription
Quality of life scoreChange from baseline (0 week) to follow up (4 weeks)The World Health Organization Quality of Life Briefing

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026