Viewing Study NCT04686019



Ignite Creation Date: 2024-05-06 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 1:52 PM
Study NCT ID: NCT04686019
Status: UNKNOWN
Last Update Posted: 2021-08-30
First Post: 2020-10-28

Brief Title: More Air - Better Performance - Faster Recovery
Sponsor: Central Jutland Regional Hospital
Organization: Central Jutland Regional Hospital

Study Overview

Official Title: More Air - Better Performance - Faster Recovery Study Protocol for a Randomised Controlled Trial of the Effect of Inspiratory Muscle Training for Adults Post-stroke
Status: UNKNOWN
Status Verified Date: 2020-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IMT
Brief Summary: 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

MethodsDesign 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
Detailed Description: Background Stroke results in varying disabilities physical cognitive emotional andor 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 patients 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

MethodsDesign 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None