Effects of Inspiratory Muscle Training on Respiratory and Diaphragmatic Functions, Balance Control, Exercise Capacity and Quality of Life in People After Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447272
• Other study ID #: HE-OT2023/13
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: February 2024
• Source: Hong Kong Metropolitan University
• Contact: Fang LIU
• Phone: +8613603049475
• Email: s1350035[@]live.hkmu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and the activation of other trunk muscles, this study also explores whether a 4-week IMT protocol would alter the participants' balance control by measuring the activation pattern of postural muscles, namely erector spinae, rectus abdominis, external oblique muscle, internal oblique muscle, and transversus abdominis, as reflected by muscle activity and anticipatory posture adjustments (APAs) time.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: June 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age = 18 years

• breathing spontaneously

• clinically diagnosed with ischemic and/or hemorrhagic stroke

• duration of stroke from onset falls within 1 month to 12 months after diagnosis

• no thoracic or abdominal surgery within the last 6 months

• able to understand and follow verbal instruction

• with stable cardiovascular function

• no history of chronic respiratory illness

• no facial palsy, or mild facial palsy without limitation of labial occlusion

• Modified Rankin Scale of 2, 3, or 4

• able to maintain a quiet setting sitting without feet support for at least 30 seconds

Exclusion criteria:

• acute myocardial infarction or acute heart failure

• acute pain in any part of the body

• positive clinical signs of impaired respiratory function (such as shortness of breath, hypoxemia, chronic cough and sputum retention)

• patient with a nasal feeding tube, tracheal tube and/or any condition that prevents the measurement or the implementation of the study procedure

Related Conditions & MeSH terms

• Respiratory Aspiration
• Stroke

Intervention

Other:
• sham inspiratory muscle training
This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Metropolitan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Berg Balance Scale (BBS)	The BBS measures balance and fall risk through 14 tasks scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating better balance.	baseline, after 4 weeks of intervention
Other	Timed Up and Go Test (TUG)	TUG is a test to measure the time that a participant needs to stand up from a standard armchair, walk a short distance of about 3 meters, turn around, walk back to the chair, and sit down again.	baseline, after 4 weeks of intervention
Other	10-meter Walk Test	The 10-Meter Walk Test (10MWT) measures how quickly someone can walk a 10-meter distance. It's used to assess walking speed and mobility.	baseline, after 4 weeks of intervention
Other	Falls efficacy scale international	The Falls Efficacy Scale-International (FES-I) is a questionnaire measuring fear of falling in older adults. It has 16 items, scored from 1 to 4, with higher scores indicating greater fear. It's used in clinical settings to assess fall risk and tailor interventions.	baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Other	6-Minute Walk Test	The 6-Minute Walk Test (6MWT) measures how far someone can walk in six minutes. It assesses exercise capacity and mobility.	baseline, after 4 weeks of intervention
Other	Stroke Impact Scale	The Chinese version of the Stroke Impact Scale 3.0 (SIS) will be used to measure the quality of life. A higher overall score suggests better physical, emotional, and social functioning, while a lower score may indicate more significant impairment or limitations.	baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Other	Trunk muscle activity	Surface electromyography (sEMG) (Noraxon USA, Inc., Scottsdale, AZ, USA) will be used to measure the bilateral muscle activity of the erector spinae, rectus abdominis, external oblique muscle, internal oblique muscle, and transversus abdominis during sitting and standing balance tests.	baseline, after 4 weeks of intervention
Other	Anticipatory posture adjustments (APAs) time of trunk muscles	Participants will be requested to perform a rapid shoulder flexion test on the force plate. Surface electromyography (sEMG) (Noraxon USA, Inc., Scottsdale, AZ, USA) will be used to measure Anticipatory posture adjustments (APAs) time of trunk muscles.	baseline, after 4 weeks of intervention
Other	15-point rating scale	A 15-point rating scale will be used to rate the excise tolerance changes of the patients since the beginning of IMT intervention. The scale scores range from -7 ("a very great deal worse") to 0 ("about the same") to +7 ("a very great deal better"). Therapists and patients will be blinded to each other and rate the exercise tolerance change of the patient. The averaged rates of therapist and patient will be the final rate. Patients with an average rating of +3 ("somewhat better") or higher will be considered to have improvement. Patients with an average rating of +2 (a little bit better) to -2 (a little bit worse) will be considered to have remained stable. Patients with an average rating of -3 ("somewhat worse") or lower will be considered to have worsened.	baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
Primary	Diaphragmatic thickness	The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).	baseline, after 4 weeks of intervention
Primary	Trunk Impairment Scale (TIS)	The TIS is a rating scale used to measure static sitting balance, dynamic sitting balance, and trunk coordination. The total TIS score ranges from 0 to 23 points, with a higher score indicating better trunk function.	baseline, after 4 weeks of intervention
Primary	Sitting Balance	A force plate will be used to measure changes in the center of pressure during the performance of various tasks in sitting positions.	baseline, after 4 weeks of intervention
Secondary	Forced Vital Capacity (FVC)	Forced Vital Capacity (FVC) is a measurement used in pulmonary function tests to assess lung function. It refers to the total volume of air that a person can forcibly exhale from their lungs after taking the deepest breath possible. It will be measured using the spirometer.	baseline, after 4 weeks of intervention
Secondary	Forced Expiratory Volume in one second (FEV1)	Forced Expiratory Volume in one second (FEV1) measures the volume of air a person can forcibly exhale in the first second of a forced breath. It will be measured using the spirometer.	baseline, after 4 weeks of intervention
Secondary	Maximum Inspiratory Pressure (MIP)	Maximum Inspiratory Pressure (MIP) is a measure used in pulmonary function testing to assess the strength of the respiratory muscles, particularly the muscles used for inhalation. It will be measured using the spirometer.	baseline, after 4 weeks of intervention
Secondary	Standing balance control	A force plate will be used to measure changes in the center of pressure during the performance of various tasks in standing positions.	baseline, after 4 weeks of intervention