Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

Peritoneal Metastases Clinical Trial

Official title:

Preoperative Inspiratory Muscle Training for Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05665257
• Other study ID #: Ethical approval no 2016/338
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 2020

Study information

• Verified date: December 2022
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized controlled feasibility study was to evaluate the feasibility of preoperative inspiratory muscle training in patients undergoing surgery because of peritoneal metastases. The main questions it aimed to answer was how feasible the intervention is regarding process and scientific feasibility as defined by Thabane et al 2010. Participants in the intervention group were using a handheld device to increase their inspiratory muscle strength prior to surgery and researchers compared this group to a control group who were offered a sham treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

• Surgery scheduled less than two weeks from the date of inclusion
• Inability to speak and understand Swedish

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Peritoneal Metastases

Intervention

Device:
• Inspiratory muscle training

• Mini-PEP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of preoperative inspiratory muscle training	Feasibility will be assessed using two domains: process and scientific feasibility. These domains include several parts such as recruitment rates, time available for training, intervention adherence, patient acceptability, pre-and postoperative respiratory muscle and lung function assessments, reproducibility of assessments, preliminary treatment effect, incidence of PPCs, and adverse events.	The different outcome measures are assessed continuously during a period from inclusion until discharge from the hospital. This period varied in length (3 weeks-3 months) depending on when participants were scheduled for surgery.