An interventional study of Inspiratory muscle training and Combined inspiratory and expiratory muscle training in Ischemic Heart Disease, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's enrollment of 104 is below the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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.
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.
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.
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.
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
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).
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Modified Medical Research Council Dyspnoea Scale
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.
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Fatigue
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.
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Cardiopulmonary function: level of exercise capacity
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.
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Strength and endurance of the lower limbs
1 minute sit to stand
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Upper limb strenght
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.
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Respiratory muscle strength
Maximal inspiratory preassure and Maximal expiratory preassure
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Inspiratory muscle endurance
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.
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Anxiety and depression levels
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.
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Universidad Complutense de Madrid