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

Not Applicable

Completed

• Conditions: Inspiratory Muscle Training; Postoperative Pulmonary Complications; Respiratory Muscle Function; Abdominal Surgery
• Interventions: Behavioral: Regulated care and education; Behavioral: Inspiratory muscle training

• Registration Number: NCT05239819
• Lead Sponsor: National Cheng Kung University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-04
• Study First Submitted QC: 2022-02-04
• Last Update Submitted: 2022-02-04
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care group	Regulated care and education	The Usual care group will receive regulated education.
Intervention group	Inspiratory muscle training	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.

Primary Outcome Measures

Name	Time	Method
Diaphragm mobilit	Change from baseline (0 week) to follow up (4 weeks)	Diaphragm ultrasonography
Postoperative Pulmonary complications rate	Change from baseline (0 week) to follow up (4 weeks)	According to the definition of PPCs on European Perioperative Clinical Outcome 2015
Respiratory muscles strength	Change from baseline (0 week) to follow up (4 weeks)	MIP and MEP are done by measuring the upper airway pressure

Secondary Outcome Measures

Name	Time	Method
Quality of life score	Change from baseline (0 week) to follow up (4 weeks)	The World Health Organization Quality of Life Briefing

Trial Locations

Locations (1)

National Cheng Kung University; 🇨🇳 Tainan, Taiwan