Functional IndependenceIMTNCT04686019
More Air - Better Performance - Faster Recovery
A study testing Inspiratory muscle training (IMT) in people with Functional Independence and Respiratory Insufficiency, run by Central Jutland Regional Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Independence, Respiratory Insufficiency
- What is being tested?
- Inspiratory muscle training (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Apr 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Simon S Kjeldsen, PhD student contact
Denmark1 site, 1 recruiting
- Recruiting
Regional Hospital Hammel Neurocenter
Hammel, 8450
Hanne Pallesen, post doc, +4523821365, hannpall@rm.dk
Simon S Kjeldsen, post doc, simokjel@rm.dk
About this study
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
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.
Read the 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.
- Conditions
- Functional Independence, Respiratory Insufficiency
- Being tested
- Inspiratory muscle training (IMT)
- Keywords
- Stroke,, Functioning, Fatigue, Voice volume
- Medical subject headings
- Respiratory Insufficiency, Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (IMT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | * 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 Receives: Other: Inspiratory muscle training (IMT) |
| Control group | Active comparator | Conventional neurorehabilitation Receives: Other: Inspiratory muscle training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure (MIP)
Change of MIP assess with the Power Breath. This is an objective measurement to describe the inspiratory capacity. Age specific
Measured: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Secondary outcomes (5)
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
Measured: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Fatigue Severity Scale (FSS)
to measure change of fatigue (1-63) higher scores indicating more fatigue affected.
Measured: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
6-minutes walking test
to measure change of endurance
Measured: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
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)
Measured: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
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)
Measured: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start15 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional IndependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sygekassernes Helsefond
- Responsible party
- Sponsor
- Investigators
- Jørgen F Nielsen, Professor, Study chair, Hammel Neurorehabilitation and Research Centre, University of Aarhus, Hammel, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686019
- Sponsor's protocol ID
- 1-16-02-279-20
- Acronym
- IMT
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Publications
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.
PubMed 34454573
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04686019
- Acronym / sponsor ID
- IMT / 1-16-02-279-20
- Conditions
- Functional Independence, Respiratory Insufficiency
- Keywords
- Stroke,, Functioning, Fatigue, Voice volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Sygekassernes Helsefond
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Inspiratory muscle training (IMT)* 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 |
| Control group | Active comparator | Other: Inspiratory muscle training (IMT)Conventional neurorehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control group, Intervention group |
Primary outcome
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
5 secondary outcomes
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
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
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
Voice volume
Time frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Expiratory function
Time frame: Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 34454573Sorensen 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.
- Individual participant dataSharing planned: No. no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon S Kjeldsen, PhD student contact
Jørgen F Nielsen, Professor study chair
Hammel Neurorehabilitation and Research Centre, University of Aarhus, Hammel, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training (IMT) in people with Functional Independence and Respiratory Insufficiency, run by Central Jutland Regional Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanne Pallesen, Post Doc (004523821365, hannpall@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04686019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.