Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sham inspiratory muscle training, target inspiratory muscle training.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other sham inspiratory muscle training
This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity) - Other target inspiratory muscle training
This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).
Primary outcome measures
- Diaphragmatic thickness [Time frame: baseline, after 4 weeks of intervention]
Secondary outcome measures (9)
- Forced Vital Capacity (FVC) [Time frame: baseline, after 4 weeks of intervention]
- Forced Expiratory Volume in one second (FEV1) [Time frame: baseline, after 4 weeks of intervention]
- Maximum Inspiratory Pressure (MIP) [Time frame: baseline, after 4 weeks of intervention]
- Trunk Impairment Scale (TIS) [Time frame: baseline, after 4 weeks of intervention]
- Sitting Balance [Time frame: baseline, after 4 weeks of intervention]
- Timed Up and Go Test (TUG) [Time frame: baseline, after 4 weeks of intervention]
- Falls efficacy scale international [Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention]
- 6-Minute Walk Test [Time frame: baseline, after 4 weeks of intervention]
- Stroke Impact Scale [Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06447272 · HE-OT2023/13