Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke

Hong Kong Metropolitan University

Status: Not yet enrolling

Conditions: Stroke

Treatments: Other: target inspiratory muscle training; Other: sham inspiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT06447272

HE-OT2023/13

Details and patient eligibility

About

This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.

Enrollment: 76 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged between 40 and 80 years;
• breathing spontaneously;
• clinically diagnosed with ischemic and/or haemorrhagic stroke;
• stroke duration from onset between 1 and 12 months;
• no history of 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;
• capable of maintaining a resting sitting posture without feet support for at least 30 seconds;
• no cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of ≥ 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, or sputum retention;
• with chronic cardiovascular dysfunction;
• Trunk Impairment Scale (TIS) score ≥ 20;
• presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Sham IMT

Sham Comparator group

Description:

conventional treatment + sham IMT

Treatment:

Other: sham inspiratory muscle training

Target IMT

Experimental group

Description:

conventional treatment + target IMT

Treatment:

Other: target inspiratory muscle training