More Air - Better Performance - Faster Recovery (IMT)

Central Jutland Regional Hospital

Status: Unknown

Conditions: Respiratory Insufficiency; Functional Independence

Treatments: Other: Inspiratory muscle training (IMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04686019

1-16-02-279-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

* 2 x IMT (5-10 min) 2 times a day 7 days a week for 3 weeks with or without supervision * Log-book * Conventional neurorehabilitation

Treatment:

Other: Inspiratory muscle training (IMT)

Control group

Active Comparator group

Description:

Conventional neurorehabilitation

Treatment:

Other: Inspiratory muscle training (IMT)