Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Functional Independence
  • Respiratory Insufficiency
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: External assessor unknown to the participants of the intervention group and control groupPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Background: Stroke results in varying disabilities physical, cognitive, emotional and/or social both in short term and long term. Motor impairments are significantly persistent consequences post-stroke among these are decreased respiratory muscle function, decreased ability to expand thorax and post...

Background: Stroke results in varying disabilities physical, cognitive, emotional and/or social both in short term and long term. Motor impairments are significantly persistent consequences post-stroke among these are decreased respiratory muscle function, decreased ability to expand thorax and postural dysfunction. These deficits influence the patient's ability in daily activities, fatigue, endurance and quality of life. Inspiratory muscle training (IMT) is training to improve the strength and endurance of diaphragm and the external intercostal muscles. The objective of this study is to investigate i) the effect of 3 weeks IMT to adults post-stroke to maximal inspiratory pressure (MIP) and ii) the effects of 3 weeks IMT to the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance, and expiratory function. Methods/Design: Randomised controlled trial (RCT) comparing IMT to conventional neurorehabilitation (usual practise). 80 patients, with reduced maximal inspiration pressure (MIP) hospitalized at a specialized neurorehabilitation hospital in Denmark will be included. The intervention group will add-on IMT sessions exercising at 30 % of MIP. Patients in the intervention group perform 2 sessions a day (One session of IMT with IMT threshold flute consists of 2 times 15 inspirations in normal breathing rhythm (5-10 min)), 7 days a week for 3 weeks. Training can be with or without supervision of physiotherapist.

Tracking Information

NCT #
NCT04686019
Collaborators
Sygekassernes Helsefond
Investigators
Study Chair: Jørgen F Nielsen, Professor Hammel Neurorehabilitation and Research Centre, University of Aarhus, Hammel, Denmark