Effect of Inspiratory Muscle Training on Respiratory Function, Diaphragm Thickness, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial

Hong Kong Metropolitan University1 site in 1 country84 target enrollmentFebruary 21, 2025

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Hong Kong Metropolitan University
Enrollment: 84
Locations: 1
Primary Endpoint: Diaphragmatic thickness
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and activation of other trunk muscles, this study also explores whether any effect of the 4-week IMT protocol on balance control is associated with changes in the anticipatory posture adjustments (APAs) time - the onset time of postural muscles during a required task (e.g., the rapid shoulder flexion test).

Registry

clinicaltrials.gov

Start Date

February 21, 2025

End Date

June 15, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hong Kong Metropolitan University

Responsible Party

Principal Investigator

LIU FANG

Principal Investigator

Hong Kong Metropolitan University

Eligibility Criteria

Inclusion Criteria

•Age ≥ 40 years and \< 80 years;
•breathing spontaneously;
•clinically diagnosed with ischemic and/or haemorrhagic stroke;
•duration of stroke from onset falls within 1 month to 12 months after diagnosis;
•no thoracic or abdominal surgery within the last 6 months;
•able to understand and follow verbal instructions;
•no facial palsy, or mild facial palsy without limitation of labial occlusion;
•able to maintain a resting sitting posture without feet support for at least 30 seconds;
•no cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 26);
•able to independently walk at least 10 meters with or without an assistive device.

Exclusion Criteria

•acute myocardial infarction or acute heart failure;
•acute pain in any part of the body;
•with respiratory illness or positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough and sputum retention);
•with chronic cardiovascular dysfunction;
•Trunk Impairment Scale (TIS) score ≥
•patient with a nasal feeding tube, tracheal tube and/or any condition that prevents the measurement or the implementation of the study procedure.

Outcomes

Primary Outcomes

Diaphragmatic thickness

Time Frame: baseline, after 4 weeks of intervention

The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).

Secondary Outcomes

Maximum Inspiratory Pressure (MIP)(baseline, after 4 weeks of intervention)
Forced Vital Capacity (FVC)(baseline, after 4 weeks of intervention)
Forced Expiratory Volume in one second (FEV1)(baseline, after 4 weeks of intervention)
Sitting Balance(baseline, after 4 weeks of intervention)
Trunk Impairment Scale (TIS)(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
Timed Up and Go Test (TUG)(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
Falls efficacy scale international(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
6-Minute Walk Test(baseline, after 4 weeks of intervention)
Stroke Impact Scale(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
Trunk muscle activity(baseline, after 4 weeks of intervention)
Anticipatory posture adjustments (APAs) time of trunk muscles(baseline, after 4 weeks of intervention)