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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: sham inspiratory muscle training; Other: target inspiratory muscle training

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang LIU; Phone Number: +8613603049475; Email: s1350035@live.hkmu.edu.hk
• Study Contact Backup: Name: William Wai Nam Tsang; Email: wntsang@hkmu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham IMT; conventional treatment + sham IMT	Other: sham inspiratory muscle training; This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)
Experimental: Target IMT; conventional treatment + target IMT	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Falls efficacy scale international	The Falls Efficacy Scale-International (FES-I) is a questionnaire measuring fear of falling in older adults. It consists of 16 items, each scored from 1 to 4, with higher scores indicating greater fear. The total score ranges from 16 (lowest fear) to 64 (highest fear). It is 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
Stroke Impact Scale	The Chinese version of the Stroke Impact Scale 3.0 (SIS) will be used to measure the quality of life. Scores range from 0 to 100, 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hong Kong Metropolitan University
• Investigators: Principal Investigator: Fang LIU, Hong Kong Metropolitan University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 1, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Inspiratory muscle training; Balance control; Diaphragm; Exercise capacity
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HE-OT2023/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No