Inspire: INSpiratory muscle training for Patients admitted to ICU and outcomes on Recovery: a pilot randomized controlled trial

Inspire: INSpiratory muscle training for Patients admitted to ICU and outcomes on Recovery: a pilot randomized controlled trial - INSPIRE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57767

Enrollment

Registered

2024-12-17

Start date

2025-11-03

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory muscle weakness weakness of the breathing muscles

Interventions

A potential subject who meets any of the following criteria will be excluded from participation in this study: - (Partial) paralyse of the diafragm - Incapable of performing assignments (RASS -3, -4

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients with ventilation duration = 48 hours, who have been successfully  detubated or in patients who have a tracheostoma, when they can breathe  independently for at least 48 hours.

Exclusion criteria

Exclusion criteria: Patient with (partial) diaphragmatic paralysis. Patients unable to follow instructions (RASS -3, -4, -5, +2, +3, +4). Patients with severe neurological disorders and/or brain injury. Patients with contraindications for IMT (including pneumothorax, air leakage via thoracic drain). Patients with insufficient command of the Dutch language.

Design outcomes

Primary

Measure	Time frame
Feasibility of intervention: - Adherence: % training sessions followed (including homework exercises). - Fidelity: degree to which prescribed intensity of intervention was carried out. - Acceptance and satisfaction of patients and physical therapists (with questionnaires and interviews). - Recording adverse or unwanted effects. Feasibility study procedures: - Eligibility (criteria) and recruitment rate (number of patients approached and/or assessed for eligibility/ analyzed for pilot objectives). - % lost to follow-up, including reason for dropout. - Feasibility and time required of data collection and outcomes: % of complete data collection. - Exploration spread of effect outcomes for purposes of power calculation final RCT.	—

Measure

Time frame

Feasibility of intervention: - Adherence: % training sessions followed (including homework exercises). - Fidelity: degree to which prescribed intensity of intervention was carried out. - Acceptance and satisfaction of patients and physical therapists (with questionnaires and interviews). - Recording adverse or unwanted effects. Feasibility study procedures: - Eligibility (criteria) and recruitment rate (number of patients approached and/or assessed for eligibility/ analyzed for pilot objectives). - % lost to follow-up, including reason for dropout. - Feasibility and time required of data collection and outcomes: % of complete data collection. - Exploration spread of effect outcomes for purposes of power calculation final RCT.

—

Secondary

Measure	Time frame
- Exercise capacity (2 minute step-test and 6-minute walk test) - Maximum inspiratory muscle strength (MIP) - Promis- Physical Activity (daily activity questionnaire) - Fatigue (Modified Fatique Inventory (MFI-20) - Dyspnea scale (MRC-dyspnea) - Hand grip strength (Jamar)	—

Countries

Netherlands

Contacts

Public ContactB.L Tempert- de Haan

Medisch Spectrum Twente (MST)

B.Tempert-deHaan@mst.nl0621876433

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026