Ischemic Heart Disease
Conditions
Keywords
Respiratory muscle training, Cardiac rehabilitation, Quality of Life, cardiopulmonary function, physical state, psychological state, Telerehabilitation
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.
Interventions
OTHERInspiratory muscle training
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.
OTHERSham combined inspiratory and expiratory muscle training
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.
OTHERConventional cardiac rehabilitation programme
Following the respiratory muscle training programme, participants will transition to a center-based cardiovascular exercise programme conducted twice weekly for eight weeks.
Sponsors
Universidad Complutense de Madrid
Instituto de Salud Carlos III
Instituto de Investigación Sanitaria Hospital Clínico San Carlos
European Regional Development Fund
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Spain
Outcome results
None listed