Effects of Home-based Respiratory Muscle Training Progamme in Individuals With Ischemic Heart Disease
NCT ID: NCT06856915
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2025-05-01
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inspiratory muscle training group + Exercise training
Participants in this group will perform a home-based inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
Inspiratory muscle training
Participants will engage in inspiratory muscle training programme at home using an inspiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Conventional cardiac rehabilitation programme
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
Inspiratory muscle training sham group + Exercise training
Participants in this group will perform a home-based sham inspiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
Sham inspiratory muscle training
Participants will engage in sham inspiratory muscle training programme at home using a sham inspiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Conventional cardiac rehabilitation programme
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
Inspiratory and expiratory muscle training group + Exercise training
Participants in this group will perform a home-based inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
Combined inspiratory and expiratory muscle training
Participants will engage in inspiratory+expiratory muscle training programme at home using an inspiratory+expiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Conventional cardiac rehabilitation programme
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
Inspiratory and expiratory muscle training Sham group + Exercise training
Participants in this group will perform a home-based sham inspiratory and expiratory muscle training programme (8 weeks) by telerehabilitation and after a center-based conventional cardiovascular exercise programme (8 weeks)
Sham combined inspiratory and expiratory muscle training
Participants will engage in sham inspiratory+expiratory muscle training programme at home using a sham inspiratory+expiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Conventional cardiac rehabilitation programme
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
Interventions
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Inspiratory muscle training
Participants will engage in inspiratory muscle training programme at home using an inspiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Combined inspiratory and expiratory muscle training
Participants will engage in inspiratory+expiratory muscle training programme at home using an inspiratory+expiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Sham inspiratory muscle training
Participants will engage in sham inspiratory muscle training programme at home using a sham inspiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Sham combined inspiratory and expiratory muscle training
Participants will engage in sham inspiratory+expiratory muscle training programme at home using a sham inspiratory+expiratory muscle training threshold device . This training will be conducted twice daily, five days a week, for eight weeks, with physiotherapist supervision provided three times per week by telerehabilitation.
Conventional cardiac rehabilitation programme
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Cardiovascular clinical stability
Exclusion Criteria
* Inability to close the lips to hold the training device's mouthpiece (e.g., facial paralysis)
* Previous participation in a rehabilitation programme within the last 3 months
* Pregnancy
* Inability to adhere to remote monitoring
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Instituto de Investigación Sanitaria Hospital Clínico San Carlos
UNKNOWN
European Regional Development Fund
OTHER
Hospital Universitario 12 de Octubre
OTHER
Universidad Complutense de Madrid
OTHER
Responsible Party
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Ibai López de Uralde Villanueva
Tenure-track professor with a PhD in the Department of Radiology, Physiotherapy and Rehabilitation
Locations
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Departamento de Radiología, Rehabilitación y Fisioterapia, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PI23/00816
Identifier Type: -
Identifier Source: org_study_id
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