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Completed

NCT Number: NCT06856915

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

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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

  1. Health related quality of life

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

    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).

Secondary outcomes

  1. Modified Medical Research Council Dyspnoea Scale

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

    The modified Medical Research Council (mMRC) assess the degree of functional disability due to dyspnoea. The mMRC breathlessness scale ranges from grade 0 to 4. Higher scores mean a worse dyspnoea.

  2. Fatigue

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

    Multidimensional Fatigue Inventory (MFI-17) The MFI is a valid and reliable instrument for assessing fatigue severity. It consists in 17 items ranked from 1 to 5, the maximun value is 85 points and the minimum 17 points. Higher scores mean a worse fatigue.

  3. Cardiopulmonary function: level of exercise capacity

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

    Exercise capacity will be measured using a Cardiopulmonary exercise testing (CPET) that precisely defines maximum exercise capacity through measurement of peak oxygen uptake. The following parameters will be acquired by breath-by-breath analysis using an automated gas analyzer: minute ventilation rate; oxygen consumption (VO2); carbon dioxide production (VCO2); and the other variables of to assess aerobic capacity and to identify potential limiting factors.

    An electrocardiogram and blood pressures will be recorded at rest, throughout exercise and during recovery.

  4. Strength and endurance of the lower limbs

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

    1 minute sit to stand

  5. Upper limb strenght

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

    Upper limb muscle strength (handgrip force) will be assessed using a hand-held dynamometer. Three measurements will be performed for each hand, alternating sides, with the elbow at 90° flexion. The best value will be recorded in kilogrames.

  6. Respiratory muscle strength

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

    Maximal inspiratory preassure and Maximal expiratory preassure

  7. Inspiratory muscle endurance

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

    Inspiratory muscle endurance will be assed by an incremental load test that required subjects to breathe against inspiratory threshold loads that were increased each minute by 10% of baseline PI,max until voluntary task failure muscle endurance test. Inspiratory muscle endurance was defined as the PI,max sustained for a minimum of 1 min.

  8. Anxiety and depression levels

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

    The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire for detecting states of anxiety and depression. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • European Regional Development Fund
  • Hospital Universitario 12 de Octubre
  • Instituto de Investigación Sanitaria Hospital Clínico San Carlos
  • Instituto de Salud Carlos III

Registry information

Official study title

Effects of Home-based Respiratory Muscle Training by Telerehabilitation on Quality of Life, Cardiopulmonary Function, Physical Status and Psychological Status in Individuals With Ischemic Heart Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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