Clinical trial NCT04686019: More Air - Better Performance - Faster Recovery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Independence
Respiratory Insufficiency
Keywords: Stroke,
Functioning
Fatigue
Voice volume
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
Collaborators: name: Sygekassernes Helsefond
First posted: 2020-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* First time brain infarction or brain haemorrhage 0-6 month.
* Able to give written consent and being cognitive and communicative able to understand and participate in the maximal inspiration pressure test (MIP)
* Reduced MIP below gender and age specific normal standard

Exclusion Criteria:

* Diagnosis of myocardial infarction within the last 3 months
* Significant pulmonary disease (severe COPD), saturation below 90 if having COPD for others saturation below 92
* Neurological deficits other than stroke
* Facial palsy that affects proper labial occlusion
* Dizziness or nausea/vomiting during MIP-testing.

Primary outcomes:
measure: Maximal inspiratory pressure (MIP)
timeFrame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Secondary outcomes:
measure: Functional Independence Measure (FIM) - both total score ( range from 18 to 126, with higher scores indicating more independence) and motor sub score (max 91)
timeFrame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
measure: Fatigue Severity Scale (FSS)
timeFrame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
measure: 6-minutes walking test
timeFrame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
measure: Voice volume
timeFrame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
measure: Expiratory function
timeFrame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Regional Hospital Hammel Neurocenter
Study officials:
affiliation: Hammel Neurorehabilitation and Research Centre, University of Aarhus, Hammel, Denmark
name: Jørgen F Nielsen, Professor
role: STUDY_CHAIR
References:
citation: Sorensen SL, Kjeldsen SS, Mortensen SS, Hansen UT, Hansen D, Pedersen AR, Pallesen H. "More air-better performance-faster recovery": study protocol for randomised controlled trial of the effect of post-stroke inspiratory muscle training for adults. Trials. 2021 Aug 28;22(1):575. doi: 10.1186/s13063-021-05551-8.