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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05239819
Other study ID # B-BR-108-012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date December 1, 2020

Study information

Verified date February 2022
Source National Cheng Kung University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
Regulated care and education
Regulated care and education will be applied

Locations

Country Name City State
Taiwan National Cheng Kung University Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary Respiratory muscles strength MIP and MEP are done by measuring the upper airway pressure Change from baseline (0 week) to follow up (4 weeks)
Primary Diaphragm mobilit Diaphragm ultrasonography Change from baseline (0 week) to follow up (4 weeks)
Secondary Quality of life score The World Health Organization Quality of Life Briefing Change from baseline (0 week) to follow up (4 weeks)
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