More Air - Better Performance - Faster Recovery (IMT)

"More Air - Better Performance - Faster Recovery": Study Protocol for a Randomised Controlled Trial of the Effect of Inspiratory Muscle Training for Adults Post-stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency; Functional Independence
• Intervention / Treatment: Other: Inspiratory muscle training (IMT)

Detailed Description

Background: Stroke results in varying disabilities physical, cognitive, emotional and/or social both in short term and long term. Motor impairments are significantly persistent consequences post-stroke among these are decreased respiratory muscle function, decreased ability to expand thorax and postural dysfunction. These deficits influence the patient's ability in daily activities, fatigue, endurance and quality of life. Inspiratory muscle training (IMT) is training to improve the strength and endurance of diaphragm and the external intercostal muscles. 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. The intervention group will add-on IMT sessions exercising at 30 % of MIP. Patients in the intervention group perform 2 sessions a day (One session of IMT with IMT threshold flute consists of 2 times 15 inspirations in normal breathing rhythm (5-10 min)), 7 days a week for 3 weeks. Training can be with or without supervision of physiotherapist.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanne Pallesen, Post Doc; Phone Number: 004523821365; Email: hannpall@rm.dk
• Study Contact Backup: Name: Simon S Kjeldsen, PhD student; Email: simokjel@rm.dk

Study Locations

• Denmark
  • Hammel, Denmark, 8450
    • Recruiting
    • Regional Hospital Hammel Neurocenter
    • Contact: Hanne Pallesen, post doc; Phone Number: +4523821365; Email: hannpall@rm.dk
    • Contact: Simon S Kjeldsen, post doc; Email: simokjel@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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); 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.
ACTIVE_COMPARATOR: Control group; Conventional neurorehabilitation	Other: Inspiratory muscle training (IMT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Independence Measure (FIM) - both total score ( range from 18 to 126, with higher scores indicating more independence) and motor sub score (max 91)	to assess the degree of changed dependency in daily activities	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Fatigue Severity Scale (FSS)	to measure change of fatigue (1-63) higher scores indicating more fatigue affected.	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
6-minutes walking test	to measure change of endurance	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Voice volume	to measure change of voice volume by recording of an a-sound with the App Voice Analyst and to measure Phonation endurance (how long the a-sound last)	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention
Expiratory function	To measure change of Peak expiratory flow (PEF), Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC) and FEV1/FVC ratio will be assessed with a peak flow meter (Spirometry device Micro 6300)	Assessed 0-4 days before intervention, 0-4 days after ended intervention assessment and 3 months after ended intervention

Collaborators and Investigators

• Sponsor: Central Jutland Regional Hospital
• Collaborators: Sygekassernes Helsefond
• Investigators: Study Chair: Jørgen F Nielsen, Professor, Hammel Neurorehabilitation and Research Centre, University of Aarhus, Hammel, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (ACTUAL): December 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Fatigue; Functioning; Stroke,; Voice volume
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 1-16-02-279-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No