Inspiratory Muscle TrainingNCT05300074
Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial
A study testing Inspiratory Muscle Training in people with Inspiratory Muscle Training, run by Spinal Cord Injury Centre of Western Denmark at 1 site in Denmark.
Trial summary
The objective of this study is to investigate if six weeks of high intensity Inspiratory Muscle Training (IMT) performed two times a week has the same effect as five times a week in hospitalized patients with first time Spinal Cord Injury (SCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inspiratory Muscle Training
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 1 Dec 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 SCI within 0-6 months
- Age ≥ 18 years
- Neurological level: C4 -TH12 and C1-C4 (AIS D only)
- Severity/ AIS: A, B, C or D
- Able to give informed concent and understand and read Danish
- Mental able to understand and participate in a lung function assessment
- Decreased MIP according to normal gender and age adjusted MIP values
Who cannot join
- Lung disease or lung infection at the time of inclusion
- Co-morbidity or other contra indications
- Injury that hinder mouth shutting
- Respirator or tracheal tube use
- Experience of severe dizziness or vomiting during training
- Not expected to be hospitalised for at least 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to investigate if six weeks of high intensity Inspiratory Muscle Training (IMT) performed two times a week has the same effect as five times a week in hospitalized patients with first time Spinal Cord Injury (SCI).
Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced Maximal Inspiration Pressure (MIP) will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on Rating Perceived Exertion (RPE), voice performance, Quality Of Life (QOL)and sleep quality. Furthermore, long term follow-up at 12 months after start of intervention will also be performed.
Read the detailed description
Background: SCI may result in various disabilities including both physical, cognitive, emotional and social domains. Motor function and function of the respiratory muscles are often decreased and may influence the patient's activities of daily activities and QOL. IMT is training to improve the strength and endurance of diaphragm and the external intercostal muscles. Various training protocols of IMT have shown efficient to increase lung function. Although, a recent meta-analysis suggest that high intensity training may be more efficient it is less clear at what weekly frequency IMT should be performed.
Thus, the objective of this study is to investigate if six weeks of high intensity IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time SCI.
Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced MIP will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on end of treatment and long term follow-up (12 months after start of intervention) in RPE, voice performance, QOL and sleep quality. The two intervention arms will consist of one arm training two times a week and the other arm training five times a week. The training protocol in both arms will include five rounds of IMT with 12 repetitions at 60 % of MIP. MIP will be increased 10 % every week if tolerated by the patient until 80 % of MIP is reached. After six weeks patients are motivated to continue training by themself up to 12 months after start of intervention.
- Conditions
- Inspiratory Muscle Training
- Being tested
- Inspiratory Muscle Training
- Keywords
- IMT, Maximal inspiratory pressure, MIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
IMT is performed with an IMT Threshold flute that can be adjusted according to the MIP. The training resistance start at 60% MIP and is calculated weekly and end (if tolerated) at 80 % MIP.
| Study group | Role | What they receive |
|---|---|---|
| Training two times per week | Experimental | Training two times per week. IMT with 5 rounds and 12 repetitions in each round at 60-80% MIP. The primary protocol will end at 6 weeks and the self-administered long-term protocol will end at 12 months after intervention start. Receives: Other: Inspiratory Muscle Training |
| Training five times per week | Experimental | Training five times per week. IMT with 5 rounds and 12 repetitions in each round at 60-80% MIP. The primary protocol will end at 6 weeks and the self-administered long-term protocol will end at 12 months after intervention start. Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
MIP is an objective measurement that indirectly describe the inspiratory muscle strength
Measured: Change from baseline assessment (0-4 days before treatment start) to End of treatment assessment (6 weeks after intervention start)
Secondary outcomes (6)
Rating of Perceived Exertion
RPE is a way of measuring physical activity intensity level. RPE will be reported in regard to the IMT training and will express the experience of how hard the IMT was feelt.
Measured: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Voice performance
The voice performance is measured with voice volume recording of an a-sound with the App Voice Analyst along with phonation endurance.
Measured: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Experienced quality of life measured with the The basic Spinal cord injury (SCI) Data Set for Qualify of Life
The basic SCI Data Set for Qualify of Life consists of QOL measured by three domains; overall, physical and mental QOL. Each domain is subjectively rated on a 0-10 scale, with 0 = completely dissatisfied and 10 = completely satisfied.
Measured: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Experienced sleep Quality measured with Pittsburgh Sleep Quality Index (PSQI) tool
Sleep quality is measured by sleep quality experience and report of circumstances that may influence sleep. The global PSQI score is calculated by totaling the seven component scores (Each weighted on a 0-3 interval scale), providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Maximal inspiratory pressure
MIP is an objective measurement that indirectly describe the inspiratory muscle strength
Measured: Change from baseline assessment (0-4 days before treatment start) to longterm follow up (12 months after intervention start)
Patients' Global Impression of Change (PGIC) scale
Patient reported outcome at follow up. Scores from 0 to 6, with 0 reporting no change and 6 aa significant change.
Measured: collected at 6 week and 12 months after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Dec 2023
Why it stopped: adjustments needed after pilot period and delay because of reduced staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inspiratory Muscle TrainingStudies 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Cord Injury Centre of Western Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Erhard T. Næss-Schmidt, PhD, Principal investigator, Spinal Cord Injury Centre of Western Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300074
- Sponsor's protocol ID
- 1-10-72-378-21
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05300074
- Acronym / sponsor ID
- 1-10-72-378-21
- Conditions
- Inspiratory Muscle Training
- Keywords
- IMT, Maximal inspiratory pressure, MIP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: adjustments needed after pilot period and delay because of reduced staff
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Spinal Cord Injury Centre of Western DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 29 Mar 2022 (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 if six weeks of high intensity Inspiratory Muscle Training (IMT) performed two times a week has the same effect as five times a week in hospitalized patients with first time Spinal Cord Injury (SCI).
Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced Maximal Inspiration Pressure (MIP) will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on Rating Perceived Exertion (RPE), voice performance, Quality Of Life (QOL)and sleep quality. Furthermore, long term follow-up at 12 months after start of intervention will also be performed.
Detailed description
Background: SCI may result in various disabilities including both physical, cognitive, emotional and social domains. Motor function and function of the respiratory muscles are often decreased and may influence the patient's activities of daily activities and QOL. IMT is training to improve the strength and endurance of diaphragm and the external intercostal muscles. Various training protocols of IMT have shown efficient to increase lung function. Although, a recent meta-analysis suggest that high intensity training may be more efficient it is less clear at what weekly frequency IMT should be performed.
Thus, the objective of this study is to investigate if six weeks of high intensity IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time SCI.
Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced MIP will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on end of treatment and long term follow-up (12 months after start of intervention) in RPE, voice performance, QOL and sleep quality. The two intervention arms will consist of one arm training two times a week and the other arm training five times a week. The training protocol in both arms will include five rounds of IMT with 12 repetitions at 60 % of MIP. MIP will be increased 10 % every week if tolerated by the patient until 80 % of MIP is reached. After six weeks patients are motivated to continue training by themself up to 12 months after start of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Training two times per week | Experimental | Other: Inspiratory Muscle TrainingTraining two times per week. IMT with 5 rounds and 12 repetitions in each round at 60-80% MIP. The primary protocol will end at 6 weeks and the self-administered long-term protocol will end at 12 months after intervention start. |
| Training five times per week | Experimental | Other: Inspiratory Muscle TrainingTraining five times per week. IMT with 5 rounds and 12 repetitions in each round at 60-80% MIP. The primary protocol will end at 6 weeks and the self-administered long-term protocol will end at 12 months after intervention start. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First time SCI within 0-6 months
- Age ≥ 18 years
- Neurological level: C4 -TH12 and C1-C4 (AIS D only)
- Severity/ AIS: A, B, C or D
- Able to give informed concent and understand and read Danish
Key exclusion criteria (6 listed)
- Lung disease or lung infection at the time of inclusion
- Co-morbidity or other contra indications
- Injury that hinder mouth shutting
- Respirator or tracheal tube use
- Experience of severe dizziness or vomiting during training
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 TrainingIMT is performed with an IMT Threshold flute that can be adjusted according to the MIP. The training resistance start at 60% MIP and is calculated weekly and end (if tolerated) at 80 % MIP. | Other | Training five times per week, Training two times per week |
Primary outcome
Maximal inspiratory pressure
Time frame: Change from baseline assessment (0-4 days before treatment start) to End of treatment assessment (6 weeks after intervention start)
MIP is an objective measurement that indirectly describe the inspiratory muscle strength
6 secondary outcomes
Rating of Perceived Exertion
Time frame: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Voice performance
Time frame: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Experienced quality of life measured with the The basic Spinal cord injury (SCI) Data Set for Qualify of Life
Time frame: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Experienced sleep Quality measured with Pittsburgh Sleep Quality Index (PSQI) tool
Time frame: Baseline assessment (0-4 days before treatment start), End of treatment assessment (6 weeks after intervention start) Longterm follow up (12 months after intervention start)
Maximal inspiratory pressure
Time frame: Change from baseline assessment (0-4 days before treatment start) to longterm follow up (12 months after intervention start)
Patients' Global Impression of Change (PGIC) scale
Time frame: collected at 6 week and 12 months after start of the intervention
Results and safety
The study was stopped early (reason given: adjustments needed after pilot period and delay because of reduced staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No. no plan
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Home-based Inspiratory Muscle Training in Pulmonary Hypertension
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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.
Erhard T. Næss-Schmidt, PhD principal investigator
Spinal Cord Injury Centre of Western 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 in people with Inspiratory Muscle Training, run by Spinal Cord Injury Centre of Western Denmark 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 Apr 2024. 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?
The study was stopped early (reason given: adjustments needed after pilot period and delay because of reduced staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (time frame: Change from baseline assessment (0-4 days before treatment start) to End of treatment assessment (6 weeks after intervention start)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.