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

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHong Kong Metropolitan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • sham inspiratory muscle training

    Other intervention

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

  • target inspiratory muscle training

    Other intervention

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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Sham IMTSham comparator 1 intervention
Group B: Target IMTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diaphragmatic thickness

The diaphragmatic thickness of both the left and right diaphragms will be measured by ultrasound. (Mindray M9, Shenzhen, China).

Time frame
baseline, after 4 weeks of intervention

Secondary outcomes

1

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.

Time frame
baseline, after 4 weeks of intervention
2

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.

Time frame
baseline, after 4 weeks of intervention
3

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.

Time frame
baseline, after 4 weeks of intervention
4

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.

Time frame
baseline, after 4 weeks of intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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