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

March 10, 2025 updated by: LIU FANG, Hong Kong Metropolitan University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
baseline, after 4 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trunk Impairment Scale (TIS)
Time Frame: baseline, after 4 weeks of intervention
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
Time Frame: baseline, after 4 weeks of intervention
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)
Time Frame: baseline, after 4 weeks of intervention
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)
Time Frame: baseline, after 4 weeks of intervention
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)
Time Frame: baseline, after 4 weeks of intervention
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)
Time Frame: baseline, after 4 weeks of intervention
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
Time Frame: baseline, after 4 weeks of intervention
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
Time Frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
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
Time Frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: baseline, after 4 weeks of intervention
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)
Time Frame: baseline, after 4 weeks of intervention
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
Time Frame: baseline, after 4 weeks of intervention
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
Time Frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
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
Time Frame: baseline, after 4 weeks of intervention
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
Time Frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hong Kong Metropolitan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fang LIU, Hong Kong Metropolitan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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