Clinical trial NCT06447272: Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke
Official title: Effects of Inspiratory Muscle Training on Respiratory and Diaphragmatic Functions, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Inspiratory muscle training
Diaphragm
Balance control
Exercise capacity
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragmatic thickness
timeFrame: baseline, after 4 weeks of intervention
Secondary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: baseline, after 4 weeks of intervention
measure: Forced Expiratory Volume in one second (FEV1)
timeFrame: baseline, after 4 weeks of intervention
measure: Maximum Inspiratory Pressure (MIP)
timeFrame: baseline, after 4 weeks of intervention
measure: Trunk Impairment Scale (TIS)
timeFrame: baseline, after 4 weeks of intervention
measure: Sitting Balance
timeFrame: baseline, after 4 weeks of intervention
measure: Timed Up and Go Test (TUG)
timeFrame: baseline, after 4 weeks of intervention
measure: Falls efficacy scale international
timeFrame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
measure: 6-Minute Walk Test
timeFrame: baseline, after 4 weeks of intervention
measure: Stroke Impact Scale
timeFrame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Metropolitan University
name: Fang LIU
role: PRINCIPAL_INVESTIGATOR
References: