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

NCT06856915 | Completed

• 1 other identifier: PI23/00816
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Heart Disease

Keywords

Respiratory muscle training; Cardiac rehabilitation; Quality of Life; cardiopulmonary function; physical state; psychological state; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  EuroQol-five-dimensional Questionnaire A numerical value represented Health state as EQ-5D 'index values' or 'index scores' reflecting how good or bad a health state is. The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

  Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

Secondary Outcomes (8)

• Modified Medical Research Council Dyspnoea Scale

  Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

• Fatigue

  Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

• Cardiopulmonary function: level of exercise capacity

  Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

• Strength and endurance of the lower limbs

  Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

• Upper limb strenght

  Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)

Study Arms (4)

Inspiratory muscle training group + Exercise training

ACTIVE COMPARATOR

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)

Other: Inspiratory muscle training; Other: Conventional cardiac rehabilitation programme

Inspiratory muscle training sham group + Exercise training

SHAM COMPARATOR

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)

Other: Sham inspiratory muscle training; Other: Conventional cardiac rehabilitation programme

Inspiratory and expiratory muscle training group + Exercise training

EXPERIMENTAL

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)

Other: Combined inspiratory and expiratory muscle training; Other: Conventional cardiac rehabilitation programme

Inspiratory and expiratory muscle training Sham group + Exercise training

SHAM COMPARATOR

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)

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

Interventions

Sham inspiratory muscle training 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.

Inspiratory muscle training sham group + Exercise training

Inspiratory muscle training 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.

Inspiratory muscle training group + Exercise training

Combined inspiratory and expiratory muscle training 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.

Inspiratory and expiratory muscle training group + Exercise training

Sham combined inspiratory and expiratory muscle training 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.

Inspiratory and expiratory muscle training Sham group + Exercise training

Conventional cardiac rehabilitation programme 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; Inspiratory and expiratory muscle training group + Exercise training; Inspiratory muscle training group + Exercise training; Inspiratory muscle training sham group + Exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Instituto de Salud Carlos III: collaborator
• Instituto de Investigación Sanitaria Hospital Clínico San Carlos: collaborator
• European Regional Development Fund: collaborator
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (1)

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

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenure-track professor with a PhD in the Department of Radiology, Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: March 4, 2025
• Study Start: May 1, 2025
• Primary Completion: February 6, 2026
• Study Completion: February 6, 2026
• Last Updated: March 23, 2026

Record last verified: 2025-06

Locations

ES (1)