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

Not Applicable

Not yet recruiting

• Conditions: Ischemic Heart Disease

• Registration Number: NCT06856915
• Lead Sponsor: Universidad Complutense de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Study Start: 2025-03-31
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health related quality of life	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 Outcome Measures

Name	Time	Method
Upper limb strenght	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.
Respiratory muscle strength	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)	Maximal inspiratory preassure and Maximal expiratory preassure
Inspiratory muscle endurance	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.
Anxiety and depression levels	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.
Modified Medical Research Council Dyspnoea Scale	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.
Fatigue	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.
Cardiopulmonary function: level of exercise capacity	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.
Strength and endurance of the lower limbs	Pre -intervention, at the end of the respiratory muscle training (8 weeks) and post intervention(16 weeks)	1 minute sit to stand

Trial Locations

Locations (1)

Departamento de Radiología, Rehabilitación y Fisioterapia, Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain