More Air - Better Performance - Faster Recovery

NCT04686019 | Unknown DMC

• 1 other identifier: 1-16-02-279-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate i) the effect of 3 weeks IMT to adults post-stroke to maximal inspiratory pressure (MIP) and ii) the effects of 3 weeks IMT to the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance, and expiratory function. Methods/Design: Randomised controlled trial (RCT) comparing IMT to conventional neurorehabilitation (usual practise). 80 patients, with reduced maximal inspiration pressure (MIP) hospitalized at a specialized neurorehabilitation hospital in Denmark will be included.

Conditions

Functional Independence; Respiratory Insufficiency

Keywords

Stroke,; Functioning; Fatigue; Voice volume

Outcome Measures

Primary Outcomes (1)

• Maximal inspiratory pressure (MIP)

  Change of MIP assess with the Power Breath. This is an objective measurement to describe the inspiratory capacity. Age specific

  Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention

Secondary Outcomes (5)

• Functional Independence Measure (FIM) - both total score ( range from 18 to 126, with higher scores indicating more independence) and motor sub score (max 91)

  Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention

• Fatigue Severity Scale (FSS)

  Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention

• 6-minutes walking test

  Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention

• Voice volume

  Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention

• Expiratory function

  Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

* 2 x IMT (5-10 min) 2 times a day 7 days a week for 3 weeks with or without supervision * Log-book * Conventional neurorehabilitation

Other: Inspiratory muscle training (IMT)

Control group

ACTIVE COMPARATOR

Conventional neurorehabilitation

Other: Inspiratory muscle training (IMT)

Interventions

Inspiratory muscle training (IMT) OTHER

IMT and conventional neurorehabilitation - treatment as usual. The intervention group will add-on IMT sessions exercising at 30 % of MIP. MIP is measured by instructing the patient to perform five forceful inspirations against an occluded mouthpiece (Power Breath). The best score is multiplied by 0.3 to determine the resistance. IMT is performed with IMT Threshold flute with the calculated resistance. During the measurement with Power Breath the patient sits straight up and uses nose clip. The patient can receive help to hold the Power Breath if necessary. One session of IMT with IMT threshold flute consists of 2 times 15 inspirations in normal breathing rhythm (5-10 min). Patients in the intervention group perform 2 sessions a day (morning and evening), training is performed prior to a meal, 7 days a week for 3 weeks.

Control group; Intervention group

Eligibility Criteria

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

You may qualify if:

• First time brain infarction or brain haemorrhage 0-6 month.
• Able to give written consent and being cognitive and communicative able to understand and participate in the maximal inspiration pressure test (MIP)
• Reduced MIP below gender and age specific normal standard

You may not qualify if:

• Diagnosis of myocardial infarction within the last 3 months
• Significant pulmonary disease (severe COPD), saturation below 90 if having COPD for others saturation below 92
• Neurological deficits other than stroke
• Facial palsy that affects proper labial occlusion
• Dizziness or nausea/vomiting during MIP-testing.

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• Sygekassernes Helsefond: collaborator

Study Sites (1)

Regional Hospital Hammel Neurocenter

Hammel, 8450, Denmark

RECRUITING

Related Publications (1)

• Sorensen SL, Kjeldsen SS, Mortensen SS, Hansen UT, Hansen D, Pedersen AR, Pallesen H. "More air-better performance-faster recovery": study protocol for randomised controlled trial of the effect of post-stroke inspiratory muscle training for adults. Trials. 2021 Aug 28;22(1):575. doi: 10.1186/s13063-021-05551-8.

  PMID: 34454573 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Stroke; Fatigue

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jørgen F Nielsen, Professor

  Hammel Neurorehabilitation and Research Centre, University of Aarhus, Hammel, Denmark

  STUDY CHAIR

Central Study Contacts

Hanne Pallesen, Post Doc

CONTACT

004523821365; hannpall@rm.dk

Simon S Kjeldsen, PhD student

CONTACT

simokjel@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: External assessor unknown to the participants of the intervention group and control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: December 28, 2020
• Study Start: April 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: September 30, 2023
• Last Updated: August 30, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)