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Clinical Trials/NCT06447272
NCT06447272Not yet recruitingNot Applicable

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

Hong Kong Metropolitan University0 sites76 target enrollmentStarted: April 1, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
76
Primary Endpoint
Diaphragmatic thickness
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Forced Vital Capacity (FVC)(baseline, after 4 weeks of intervention)
  • Forced Expiratory Volume in one second (FEV1)(baseline, after 4 weeks of intervention)
  • Maximum Inspiratory Pressure (MIP)(baseline, after 4 weeks of intervention)
  • Trunk Impairment Scale (TIS)(baseline, after 4 weeks of intervention)
  • Sitting Balance(baseline, after 4 weeks of intervention)
  • Timed Up and Go Test (TUG)(baseline, after 4 weeks of intervention)
  • Falls efficacy scale international(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)
  • 6-Minute Walk Test(baseline, after 4 weeks of intervention)
  • Stroke Impact Scale(baseline, after 4 weeks of intervention, 12-week follow-up after the end of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

LIU FANG

Principal Investigator

Hong Kong Metropolitan University

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