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

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Ischemic Heart Disease

Treatments: Other: Sham inspiratory muscle training; Other: Inspiratory muscle training; Other: Conventional cardiac rehabilitation programme; Other: Combined inspiratory and expiratory muscle training; Other: Sham combined inspiratory and expiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT06856915

PI23/00816

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups

Inspiratory muscle training group + Exercise training

Active Comparator group

Description:

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)

Treatment:

Other: Conventional cardiac rehabilitation programme

Other: Inspiratory muscle training

Inspiratory muscle training sham group + Exercise training

Sham Comparator group

Description:

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)

Treatment:

Other: Conventional cardiac rehabilitation programme

Other: Sham inspiratory muscle training

Inspiratory and expiratory muscle training group + Exercise training

Experimental group

Description:

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)

Treatment:

Other: Conventional cardiac rehabilitation programme

Other: Combined inspiratory and expiratory muscle training

Inspiratory and expiratory muscle training Sham group + Exercise training

Sham Comparator group

Description:

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)

Treatment:

Other: Sham combined inspiratory and expiratory muscle training

Other: Conventional cardiac rehabilitation programme