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More Air - Better Performance - Faster Recovery (IMT)

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ClinicalTrials.gov Identifier: NCT04686019
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Sygekassernes Helsefond
Information provided by (Responsible Party):
Central Jutland Regional Hospital

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.


Condition or disease Intervention/treatment Phase
Functional Independence Respiratory Insufficiency Other: Inspiratory muscle training (IMT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: External assessor unknown to the participants of the intervention group and control group
Primary Purpose: Treatment
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
Actual Study Start Date : April 15, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : September 30, 2023

Arm Intervention/treatment
Experimental: Intervention group
  • 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
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.


Active Comparator: Control group
Conventional neurorehabilitation
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.





Primary Outcome Measures :
  1. Maximal inspiratory pressure (MIP) [ Time Frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention ]
    Change of MIP assess with the Power Breath. This is an objective measurement to describe the inspiratory capacity. Age specific


Secondary Outcome Measures :
  1. Functional Independence Measure (FIM) - both total score ( range from 18 to 126, with higher scores indicating more independence) and motor sub score (max 91) [ Time Frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention ]
    to assess the degree of changed dependency in daily activities

  2. Fatigue Severity Scale (FSS) [ Time Frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention ]
    to measure change of fatigue (1-63) higher scores indicating more fatigue affected.

  3. 6-minutes walking test [ Time Frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention ]
    to measure change of endurance

  4. Voice volume [ Time Frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention ]
    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)

  5. Expiratory function [ Time Frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686019


Contacts
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Contact: Hanne Pallesen, Post Doc 004523821365 hannpall@rm.dk
Contact: Simon S Kjeldsen, PhD student simokjel@rm.dk

Locations
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Denmark
Regional Hospital Hammel Neurocenter Recruiting
Hammel, Denmark, 8450
Contact: Hanne Pallesen, post doc    +4523821365    hannpall@rm.dk   
Contact: Simon S Kjeldsen, post doc       simokjel@rm.dk   
Sponsors and Collaborators
Central Jutland Regional Hospital
Sygekassernes Helsefond
Investigators
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Study Chair: Jørgen F Nielsen, Professor Hammel Neurorehabilitation and Research Centre, University of Aarhus, Hammel, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT04686019    
Other Study ID Numbers: 1-16-02-279-20
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Jutland Regional Hospital:
Stroke,
Functioning
Fatigue
Voice volume
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases