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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Hong Kong Metropolitan University
- Enrollment
- 76
- Primary Endpoint
- Diaphragmatic thickness
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
LIU FANG
Principal Investigator
Hong Kong Metropolitan University
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
- Not provided
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
- Forced Vital Capacity (FVC)(baseline, after 4 weeks of intervention)
- Forced Expiratory Volume in one second (FEV1)(baseline, after 4 weeks of intervention)
- Maximum Inspiratory Pressure (MIP)(baseline, after 4 weeks of intervention)
- Trunk Impairment Scale (TIS)(baseline, after 4 weeks of intervention)
- Sitting Balance(baseline, after 4 weeks of intervention)
- Timed Up and Go Test (TUG)(baseline, after 4 weeks 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)