More Air - Better Performance - Faster Recovery

Respiratory Insufficiency Clinical Trial

— IMT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686019
• Other study ID #: 1-16-02-279-20
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2020
• Source: Central Jutland Regional Hospital
• Contact: Hanne Pallesen, Post Doc
• Phone: 004523821365
• Email: hannpall[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Functional Independence
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• Inspiratory muscle training (IMT)
IMT and conventional neurorehabilitation - treatment as usual. The intervention group will add-on IMT sessions exercising at 30 % of MIP. MIP is measured by instructing the patient to perform five forceful inspirations against an occluded mouthpiece (Power Breath). The best score is multiplied by 0.3 to determine the resistance. IMT is performed with IMT Threshold flute with the calculated resistance. During the measurement with Power Breath the patient sits straight up and uses nose clip. The patient can receive help to hold the Power Breath if necessary. One session of IMT with IMT threshold flute consists of 2 times 15 inspirations in normal breathing rhythm (5-10 min). Patients in the intervention group perform 2 sessions a day (morning and evening), training is performed prior to a meal, 7 days a week for 3 weeks.

Locations

Country	Name	City	State
Denmark	Regional Hospital Hammel Neurocenter	Hammel

Sponsors (2)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital	Sygekassernes Helsefond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal inspiratory pressure (MIP)	Change of MIP assess with the Power Breath. This is an objective measurement to describe the inspiratory capacity. Age specific	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Secondary	Functional Independence Measure (FIM) - both total score ( range from 18 to 126, with higher scores indicating more independence) and motor sub score (max 91)	to assess the degree of changed dependency in daily activities	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Secondary	Fatigue Severity Scale (FSS)	to measure change of fatigue (1-63) higher scores indicating more fatigue affected.	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Secondary	6-minutes walking test	to measure change of endurance	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Secondary	Voice volume	to measure change of voice volume by recording of an a-sound with the App Voice Analyst and to measure Phonation endurance (how long the a-sound last)	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Secondary	Expiratory function	To measure change of Peak expiratory flow (PEF), Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC) and FEV1/FVC ratio will be assessed with a peak flow meter (Spirometry device Micro 6300)	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention