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

NCT ID: NCT06447272

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-06-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham IMT

conventional treatment + sham IMT

Group Type: SHAM_COMPARATOR

sham inspiratory muscle training

Intervention Type: OTHER

This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)

Target IMT

conventional treatment + target IMT

Group Type: EXPERIMENTAL

target inspiratory muscle training

Intervention Type: OTHER

This group will receive conventional treatment + target IMT (the IMT identified as optimal intensity based on the results of our undergoing study).

Interventions

sham inspiratory muscle training

This group will receive conventional treatment + sham IMT (with 10% MIP as the training intensity)

Intervention Type: 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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

LIU FANG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang LIU

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Metropolitan University

Central Contacts

Fang LIU

Role: CONTACT

s1350035@live.hkmu.edu.hk

+8613603049475

William Wai Nam Tsang

Role: CONTACT

wntsang@hkmu.edu.hk

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HE-OT2023/13

Identifier Type: -

Identifier Source: org_study_id