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

NCT05300074 | Terminated DMC

• 1 other identifier: 1-10-72-378-21
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Inspiratory Muscle Training

Keywords

IMT; Maximal inspiratory pressure; MIP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rating of Perceived Exertion

  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

  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

  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

  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

  Change from baseline assessment (0-4 days before treatment start) to longterm follow up (12 months after intervention start)

Study Arms (2)

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.

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.

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training 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 two times per week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spinal Cord Injury Centre of Western Denmark: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Spinal cord injury center Western Denmark

Viborg, 8800, Denmark

Location

Study Officials

• Erhard T. Næss-Schmidt, PhD

  Spinal Cord Injury Centre of Western Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 29, 2022
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 17, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)