Clinical trial NCT06856915: Effects of Home-based Respiratory Muscle Training Progamme in Individuals With Ischemic Heart Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Respiratory muscle training
Cardiac rehabilitation
Quality of Life
cardiopulmonary function
physical state
psychological state
Telerehabilitation
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Instituto de Investigación Sanitaria Hospital Clínico San Carlos
name: European Regional Development Fund
name: Hospital Universitario 12 de Octubre
First posted: 2025-03-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Secondary outcomes:
measure: Modified Medical Research Council Dyspnoea Scale
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
measure: Fatigue
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
measure: Cardiopulmonary function: level of exercise capacity
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
measure: Strength and endurance of the lower limbs
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
measure: Upper limb strenght
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
measure: Respiratory muscle strength
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
measure: Inspiratory muscle endurance
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
measure: Anxiety and depression levels
timeFrame: Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Departamento de Radiología, Rehabilitación y Fisioterapia, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid
Study officials:
References: