Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial

Inspiratory Muscle Training Clinical Trial

Official title:

Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05300074
• Other study ID #: 1-10-72-378-21
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2023
• Source: Spinal Cord Injury Centre of Western Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Inspiratory Muscle Training
• Respiratory Aspiration

Intervention

Other:
• Inspiratory Muscle Training
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.

Locations

Country	Name	City	State
Denmark	Spinal cord injury center Western Denmark	Viborg

Sponsors (2)

Lead Sponsor	Collaborator
Spinal Cord Injury Centre of Western Denmark	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal inspiratory pressure	MIP is an objective measurement that indirectly describe the inspiratory muscle strength	Change from baseline assessment (0-4 days before treatment start) to End of treatment assessment (6 weeks after intervention start)
Secondary	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.	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)
Secondary	Voice performance	The voice performance is measured with voice volume recording of an a-sound with the App Voice Analyst along with phonation endurance.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	Maximal inspiratory pressure	MIP is an objective measurement that indirectly describe the inspiratory muscle strength	Change from baseline assessment (0-4 days before treatment start) to longterm follow up (12 months after intervention start)
Secondary	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.	collected at 6 week and 12 months after start of the intervention