“More air—better performance—faster recovery”: study protocol for randomised controlled trial of the effect of post-stroke inspiratory muscle training for adults

Abstract Background Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among others, decreased respiratory muscle function, decreased ability to expand the thorax and postural dysfunction. These deficits affect the patient’s ability to perform daily activities, produce fatigue and reduce endurance and quality of life. Inspiratory muscle training (IMT) aims to improve the strength and endurance of the diaphragm and the external intercostal muscles. The objectives of this study are to investigate the effect of 3 weeks of IMT on (i) maximal inspiratory pressure (MIP) in adults having suffered a stroke, as well as (ii) functional activities and expiratory measurements. Methods/design This is a randomised controlled trial (RCT) comparing IMT with conventional neurorehabilitation (usual practice). The trial will include 80 patients with reduced MIP hospitalised at a specialised neurorehabilitation hospital in Denmark. The intervention group will receive IMT sessions, exercising at 30% of MIP. Patients in the intervention group will perform two daily sessions (one session of IMT with Threshold IMT consisting of two times 15 inspirations at normal breathing rhythm (5–10 min)), 7 days a week for 3 weeks. Training can be with or without physiotherapist supervision. Study outcomes: MIP assessed by the Power Breath, Functional Independence Measurement, The 6-min walk test, the Fatigue Severity Scale and average voice volume. Expiratory function will be assessed using spirometry. All assessments will be conducted at baseline and 3 weeks (at termination of the intervention) and 3 months after the intervention has concluded. Discussion IMT is a promising and partly self-managed tool for rehabilitation to improve respiratory function. The introduction of IMT in combination with traditional physical therapy may enhance faster recovery after stroke and may at the same time demand little personnel resources to increase training intensity. This trial will provide further evidence of IMT to clinicians, patients and health managers. Hereby, this study accepts the call for further research. Trial registration ClinicalTrials.govNCT04686019. Registered on 28 December 2020.

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"More Air – Better Performance – Faster Recovery": Study Protocol for Randomised Controlled Trial of the Effect of Post-stroke Inspiratory Muscle Training for Adults

10.21203/rs.3.rs-587798/v1 ◽

2021 ◽

Author(s):

Susanne Lillelund Sørensen ◽

Simon Svanborg Kjeldsen ◽

Sine Secher Mortensen ◽

Ulla Torp Hansen ◽

Dorthe Hansen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Activities Of Daily Living ◽

Daily Living ◽

Controlled Trial ◽

Intervention Group ◽

Functional Independence ◽

Inspiratory Muscle ◽

Inspiratory Muscle Training ◽

Muscle Training ◽

Randomised Controlled

Abstract Background: Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among others, decreased respiratory muscle function, decreased ability to expand the thorax and postural dysfunction. These deficits affect the patient's ability to perform daily activities, produce fatigue and reduce endurance and quality of life. Inspiratory muscle training (IMT) aims to improve the strength and endurance of the diaphragm and the external intercostal muscles. The objective of this study was to investigate i) the effect of three weeks of IMT on maximal inspiratory pressure (MIP) in adults having suffered a stroke, and ii) the effects of three weeks of IMT on the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance and expiratory function.Methods/Design: This is a randomised controlled trial (RCT) comparing IMT with conventional neurorehabilitation (usual practise). The trial will include 80 patients with reduced MIP hospitalised at a specialised neurorehabilitation hospital in Denmark. The intervention group will receive IMT sessions, exercising at 30% of MIP. Patients in the intervention group will perform two daily sessions (one session of IMT with Threshold IMT consisting of two times 15 inspirations at normal breathing rhythm (5-10 min)), seven days a week for three weeks. Training can be with or without physiotherapist supervision. Study outcomes: MIP assessed by the Power Breath, Functional Independence Measurement, The 6-minute Walk Test, the Fatigue Severity Scale and average voice volume. Expiratory function will be assessed using spirometry. All assessments will be conducted at baseline and three weeks (at termination of the intervention) and three months after the intervention has concluded.Discussion: The primary purpose of this study is to assess the effect of IMT interventions in patients with reduced MIP following stroke; secondarily, to assess the effect of IMT on the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance and expiratory capacity. Hereby, this study accepts the call for further research.Trial registration: ClinicalTrials.gov NCT04686019. Registered 28.12.2020, https://www.clinicaltrials.gov/ct2/show/NCT04686019

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Inspiratory muscle training does not improve clinical outcomes in 3-week COPD rehabilitation: results from a randomised controlled trial

European Respiratory Journal ◽

10.1183/13993003.02000-2017 ◽

2018 ◽

Vol 51 (1) ◽

pp. 1702000 ◽

Cited By ~ 29

Author(s):

Konrad Schultz ◽

Danijel Jelusic ◽

Michael Wittmann ◽

Benjamin Krämer ◽

Veronika Huber ◽

...

Keyword(s):

Quality Of Life ◽

Pulmonary Rehabilitation ◽

Controlled Trial ◽

Intervention Group ◽

Inspiratory Muscle ◽

Inspiratory Muscle Training ◽

Chronic Obstructive ◽

Muscle Training ◽

Randomised Controlled

The value of inspiratory muscle training (IMT) in pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) is unclear. The RIMTCORE (Routine Inspiratory Muscle Training within COPD Rehabilitation) randomised controlled trial examined the effectiveness of IMT added to pulmonary rehabilitation.In total, 611 COPD patients (Global Initiative for Chronic Obstructive Lung Disease stage II–IV) received a 3-week inpatient pulmonary rehabilitation, of which 602 patients were included in the intention-to-treat analyses. The intervention group (n=300) received highly intensive IMT and the control group (n=302) received sham IMT. The primary outcome was maximal inspiratory pressure (PImax). The secondary outcomes were 6-min walk distance, dyspnoea, quality of life and lung function. Outcomes were assessed pre- and post-pulmonary rehabilitation. ANCOVA was used.The intervention group showed higher effects in PImax (p<0.001) and forced inspiratory volume in 1 s (p=0.013). All other outcomes in both study groups improved significantly, but without further between-group differences. Sex and pulmonary rehabilitation admission shortly after hospitalisation modified quality of life effects.IMT as an add-on to a 3-week pulmonary rehabilitation improves inspiratory muscle strength, but does not provide additional benefits in terms of exercise capacity, quality of life or dyspnoea. A general recommendation for COPD patients to add IMT to a 3-week pulmonary rehabilitation cannot be made.

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