Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes

NCT06640101 | Recruiting

• 1 other identifier: No.:HE-OT2023/13
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to explore the effects of a 4-week protocol of inspiratory muscle training (IMT) at 50% maximum inspiratory pressure (MIP) on respiratory function, diaphragm thickness, balance control, exercise capacity, and quality of life in people after stroke. To ascertain the effect of IMT on the relationship between diaphragm muscle contraction and activation of other trunk muscles, this study also explores whether any effect of the 4-week IMT protocol on balance control is associated with changes in the anticipatory posture adjustments (APAs) time - the onset time of postural muscles during a required task (e.g., the rapid shoulder flexion test).

Conditions

Stroke

Keywords

Stroke; Inspiratory muscle training; Diaphragm; Balance control; Exercise capacity; Quality of life; Anticipatory postural adjustment time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Maximum Inspiratory Pressure (MIP)

  baseline, after 4 weeks of intervention

• Forced Vital Capacity (FVC)

  baseline, after 4 weeks of intervention

• Forced Expiratory Volume in one second (FEV1)

  baseline, after 4 weeks of intervention

• Sitting Balance

  baseline, after 4 weeks of intervention

• Trunk Impairment Scale (TIS)

  baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention

Study Arms (3)

Group A (sham IMT- stable group)

SHAM COMPARATOR

conventional treatment + sham IMT

Other: sham IMT; Other: Conventional treatment

Group B (IMT-stable group)

EXPERIMENTAL

conventional treatment + target IMT while sitting on a stable surface

Other: IMT-stable group (sitting on a stable surface); Other: Conventional treatment

Group C (IMT-unstable group)

EXPERIMENTAL

conventional treatment + target IMT while sitting on an unstable surface

Other: IMT-unstable group (sitting on an unstable surface); Other: Conventional treatment

Interventions

sham IMT OTHER

with 10% maximum inspiratory pressure (MIP) as the training intensity, IMT will be conducted on a stable surface

Group A (sham IMT- stable group)

IMT-stable group (sitting on a stable surface) OTHER

50% MIP as the training intensity, IMT will be conducted while sitting on a stable surface

Group B (IMT-stable group)

IMT-unstable group (sitting on an unstable surface) OTHER

50% MIP as the training intensity, IMT will be conducted while sitting on an unstable surface

Group C (IMT-unstable group)

Conventional treatment OTHER

Participants in all groups will receive a standardised conventional rehabilitation protocol. It includes limb range of motion, muscle tone reduction, strengthening and endurance of limb muscles, transfer skills, task-directed movements, general gait training, and activities of daily living training.

Group A (sham IMT- stable group); Group B (IMT-stable group); Group C (IMT-unstable group)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years and \< 80 years;
• breathing spontaneously;
• clinically diagnosed with ischemic and/or haemorrhagic 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 instructions;
• no facial palsy, or mild facial palsy without limitation of labial occlusion;
• able to maintain a resting sitting posture without feet support for at least 30 seconds;
• no cognitive impairment (Montreal Cognitive Assessment (MoCA) score ≥ 26);
• able to independently walk at least 10 meters with or without an assistive device.

You may not qualify if:

• 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 and sputum retention);
• with chronic cardiovascular dysfunction;
• Trunk Impairment Scale (TIS) score ≥ 20.
• patient with a nasal feeding tube, tracheal tube and/or any condition that prevents the measurement or the implementation of the study procedure.

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, None Selected, China

RECRUITING

Related Publications (1)

• Liu F, Jones AY, Tsang RC, Yam TT, Tsang WW. Inspiratory muscle training with balance challenge improves diaphragmatic thickness, respiratory function, balance, exercise capacity and quality of life in people after stroke: a randomised trial. J Physiother. 2026 Jan;72(1):42-52. doi: 10.1016/j.jphys.2025.12.004. Epub 2025 Dec 20.

  PMID: 41423385 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Fang LIU

CONTACT

+86 13603049475; s1350035@live.hkmu.edu.hk

William Wai-nam Tsang

CONTACT

085239708703; wntsang@hkmu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: February 21, 2025
• Primary Completion: October 15, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

CN (1)