Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial

Rehabilitation
General health
Online since 12 May 2022, updated 496 days ago

About this trial

The objective of this study is to investigate if six weeks of high intensity Inspiratory Muscle Training (IMT) performed two times a week has the same effect as five times a week in hospitalized patie...

Included participants

Gender
All
Age
≥ 18 years
Injury level
C4 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 6 months
    Healthy volunteers
    No
    C4-T12

    What’s involved

    Type

    Rehabilitation

    Details

    Background: SCI may result in various disabilities including both physical, cognitive, emotional and social domains. Motor function and function of the respiratory muscles are often decreased and may influence the patient's activities of daily activities and QOL. IMT is training to improve the strength and endurance of diaphragm and the external intercostal muscles. Various training protocols of IMT have shown efficient to increase lung function. Although, a recent meta-analysis suggest that high intensity training may be more efficient it is less clear at what weekly frequency IMT should be performed. Thus, the objective of this study is to investigate if six weeks of high intensity IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time SCI. Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced MIP will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on end of treatment and long term follow-up (6-8 months end of treatment) in RPE, voice performance, QOL and sleep quality. The two intervention arms will consist of one arm training two times a week and the other arm training five times a week. The training protocol in both arms will include five rounds of IMT with 12 repetitions at 60 % of MIP. MIP will be increased 10 % every week if tolerated by the patient until 80 % of MIP is reached. After six weeks patients are motivated to continue training by themself up to 6-8 months after end of treatment.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Mental health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Sep 2023
    • Organisation
    • Spinal Cord Injury Centre of Western Denmark
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Sep 2023
    • Organisation
    • Spinal Cord Injury Centre of Western Denmark

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more