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

NCT ID: NCT05300074

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training two times per week

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.

Group Type: EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type: OTHER

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.

Training five times per week

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.

Group Type: EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Spinal Cord Injury Centre of Western Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erhard T. Næss-Schmidt, PhD

Role: PRINCIPAL_INVESTIGATOR

Spinal Cord Injury Centre of Western Denmark

Locations

Spinal cord injury center Western Denmark

Viborg, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-378-21

Identifier Type: -

Identifier Source: org_study_id