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Completed

NCT Number: NCT05665257

Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

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.

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Key information

Conditions

Peritoneal Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training

Device

Mini-PEP

Device

Primary outcomes

  1. Feasibility of preoperative inspiratory muscle training

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2022
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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