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NCT Number: NCT06640101

Effects of Inspiratory Muscle Training on Stroke Rehabilitation Outcomes

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).

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Second People's Hospital

Shenzhen, None Selected, China

Location status: Recruiting

Location contact

Fang LIU

CONTACT

[email protected]

+8613603049475

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

sham IMT

Other

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

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

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

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Trunk Impairment Scale (TIS)

    Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end 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.

  6. Timed Up and Go Test (TUG)

    Time frame: baseline, after 4 weeks of intervention, 12-week follow-up after the end 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.

  7. 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.

  8. 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.

  9. 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.

  10. Trunk muscle activity

    Time frame: baseline, after 4 weeks of intervention

    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 balance tests on the force plate.

  11. Anticipatory posture adjustments (APAs) time of trunk muscles

    Time frame: baseline, after 4 weeks of intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang LIU

CONTACT

[email protected]

+86 13603049475

William Wai-nam Tsang

CONTACT

[email protected]

085239708703

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Official study title

Effect of Inspiratory Muscle Training on Respiratory Function, Diaphragm Thickness, Balance Control, Exercise Capacity and Quality of Life in People After Stroke: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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