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Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

Primary Purpose

Peritoneal Metastases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training
Mini-PEP
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peritoneal Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Inspiratory muscle training

    Mini-PEP

    Arm Description

    Participants in the intervention group were using a handheld device, Powerbreathe K3, aiming at increasing inspiratory muscle strength by applying an inspiratory resistance. They were instructed to use it twice a day for at least 14 days. Starting load was based on the baseline assessment of the participant's inspiratory muscle strength and increased during the intervention period.

    Participants in the control arm were instructed to use a handheld PEP-device traditionally used to facilitate deep breathing. The PEP-device does not provide any inspiratory resistance and therefore, it was considered a sham treatment. The control group were also instructed to use the device twice a day for at least two weeks.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2022
    Last Updated
    December 16, 2022
    Sponsor
    Uppsala University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05665257
    Brief Title
    Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases
    Official Title
    Preoperative Inspiratory Muscle Training for Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    September 2020 (Actual)
    Study Completion Date
    September 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uppsala University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peritoneal Metastases

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inspiratory muscle training
    Arm Type
    Experimental
    Arm Description
    Participants in the intervention group were using a handheld device, Powerbreathe K3, aiming at increasing inspiratory muscle strength by applying an inspiratory resistance. They were instructed to use it twice a day for at least 14 days. Starting load was based on the baseline assessment of the participant's inspiratory muscle strength and increased during the intervention period.
    Arm Title
    Mini-PEP
    Arm Type
    Sham Comparator
    Arm Description
    Participants in the control arm were instructed to use a handheld PEP-device traditionally used to facilitate deep breathing. The PEP-device does not provide any inspiratory resistance and therefore, it was considered a sham treatment. The control group were also instructed to use the device twice a day for at least two weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Inspiratory muscle training
    Intervention Type
    Device
    Intervention Name(s)
    Mini-PEP
    Primary Outcome Measure Information:
    Title
    Feasibility of preoperative inspiratory muscle training
    Description
    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.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mikael Andersson, PhD
    Organizational Affiliation
    Department of Medical Sciences, Respiratory, Allergy and Sleep Research, Uppsala University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified data will be shared upon reasonable request.

    Learn more about this trial

    Feasibility of Preoperative Inspiratory Muscle Training for Patients With Peritoneal Metastases

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