Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes

ConditionStroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-80

SponsorHong Kong Metropolitan University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

sham IMT
Other intervention
with 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface
IMT-stable group (sitting on a stable surface)
Other intervention
50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface
IMT-unstable group (sitting on an unstable surface)
Other intervention
50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface
Conventional treatment
Other intervention
Participants in all groups will receive a standardised conventional rehabilitation protocol. It includes limb range of motion, muscle tone reduction, strengthening and endurance of limb muscles, transfer skills, task-directed movements, general gait training, and activities of daily living training.

Treatment groups

84 Participants

are divided into 3 treatment groups

Group A: Group A (sham IMT- stable group)Sham comparator 2 interventions

Group B: Group B (IMT-stable group)Experimental treatment 2 interventions

Group C: Group C (IMT-unstable group)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Diaphragmatic thickness

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

Time frame