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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05665257
Other study ID # Ethical approval no 2016/338
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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