Ischemic Heart DiseaseNCT06856915
Effects of Home-based Respiratory Muscle Training Progamme in Individuals With Ischemic Heart Disease
A study testing Inspiratory muscle training, Combined inspiratory and expiratory muscle training and Conventional cardiac rehabilitation programme in people with Ischemic Heart Disease, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Inspiratory muscle training, Combined inspiratory and expiratory muscle training and Conventional cardiac rehabilitation programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2025to 6 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of ischemic heart disease
- Age 18 years or older
- Cardiovascular clinical stability
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Departamento de Radiología, Rehabilitación y Fisioterapia, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid
Madrid, Madrid, 28040
About this study
Official 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
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
- Being tested
- Inspiratory muscle training, Combined inspiratory and expiratory muscle training, Sham inspiratory muscle training, Sham combined inspiratory and expiratory muscle training, Conventional cardiac rehabilitation programme
- Keywords
- Respiratory muscle training, Cardiac rehabilitation, Quality of Life, cardiopulmonary function, physical state, psychological state, Telerehabilitation
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
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 trainingOther
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 trainingOther
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 trainingOther
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 programmeOther
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: Sham combined inspiratory and expiratory muscle training; Other: Conventional cardiac rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 May 2025
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Instituto de Investigación Sanitaria Hospital Clínico San Carlos, European Regional Development Fund, Hospital Universitario 12 de Octubre
- Responsible party
- Principal investigator, Ibai López de Uralde Villanueva, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856915
- Sponsor's protocol ID
- PI23/00816
- Status last verified
- Jun 2025
- First submitted
- 20 Jan 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06856915
- Acronym / sponsor ID
- PI23/00816
- Conditions
- Ischemic Heart Disease
- Keywords
- Respiratory muscle training, Cardiac rehabilitation, Quality of Life, cardiopulmonary function, physical state, psychological state, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Instituto de Investigación Sanitaria Hospital Clínico San Carlos, European Regional Development Fund, Hospital Universitario 12 de Octubre
- Study start
- 1 May 2025 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group + Exercise training | Active comparator | Other: Inspiratory muscle training, Other: Conventional cardiac rehabilitation programmeParticipants 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) |
| Inspiratory muscle training sham group + Exercise training | Sham comparator | Other: Sham inspiratory muscle training, Other: Conventional cardiac rehabilitation programmeParticipants 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) |
| Inspiratory and expiratory muscle training group + Exercise training | Experimental | Other: Combined inspiratory and expiratory muscle training, Other: Conventional cardiac rehabilitation programmeParticipants 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) |
| Inspiratory and expiratory muscle training Sham group + Exercise training | Sham comparator | Other: Sham combined inspiratory and expiratory muscle training, Other: Conventional cardiac rehabilitation programmeParticipants 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of ischemic heart disease
- Age 18 years or older
- Cardiovascular clinical stability
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingParticipants 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. | Other | Inspiratory muscle training group + Exercise training |
| Combined inspiratory and expiratory muscle trainingParticipants 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. | Other | Inspiratory and expiratory muscle training group + Exercise training |
| Sham inspiratory muscle trainingParticipants 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. | Other | Inspiratory muscle training sham group + Exercise training |
| Sham combined inspiratory and expiratory muscle trainingParticipants 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. | Other | Inspiratory and expiratory muscle training Sham group + Exercise training |
| Conventional cardiac rehabilitation programmeFollowing the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks. | Other | 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 |
Primary outcome
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).
8 secondary outcomes
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)
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
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
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Upper limb strenght
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Respiratory muscle strength
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Inspiratory muscle endurance
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Anxiety and depression levels
Time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training, Combined inspiratory and expiratory muscle training and Conventional cardiac rehabilitation programme in people with Ischemic Heart Disease, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.