Effects of Home-based Respiratory Muscle Training Progamme in Individuals With Ischemic Heart Disease

NCT ID: NCT06856915

Last Updated: 2025-06-11

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-05-01

Brief Summary

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The main objective of the present study is to verify whether respiratory muscle training programme (IMT+EMT; included both inspriratory and expiratory muscles), applied by telerehabilitation, is an effective intervention (versus placebo and versus inspiratory muscle training in isolation (IMT)) in improving quality of life, cardiopulmonary function and physical and psychological state in people with ischemic heart disease. In addition, the aim is to determine whether respiratory muscle training (IMT or IMT+EMT) is effective in enhancing the results obtained by a conventional cardiac rehabilitation programme on the aforementioned variables.

Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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)

Group Type ACTIVE_COMPARATOR

Inspiratory muscle training

Intervention Type OTHER

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

Intervention Type OTHER

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)

Group Type SHAM_COMPARATOR

Sham inspiratory muscle training

Intervention Type OTHER

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

Intervention Type OTHER

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)

Group Type EXPERIMENTAL

Combined inspiratory and expiratory muscle training

Intervention Type OTHER

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

Intervention Type OTHER

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)

Group Type SHAM_COMPARATOR

Sham combined inspiratory and expiratory muscle training

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Presence of ischemic heart disease
* Age 18 years or older
* Cardiovascular clinical stability

Exclusion Criteria

* Any condition that contraindicate exercise training
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

Instituto de Investigación Sanitaria Hospital Clínico San Carlos

UNKNOWN

Sponsor Role collaborator

European Regional Development Fund

OTHER

Sponsor Role collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departamento de Radiología, Rehabilitación y Fisioterapia, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ibai López de Uralde Villanueva, PhD

Role: CONTACT

+34 91 394 1517

Facility Contacts

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Ibai López de Uralde Villanueva, PhD

Role: primary

0034 91 394 1517

Other Identifiers

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PI23/00816

Identifier Type: -

Identifier Source: org_study_id

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