National heart institute
Cairo, AI Qahirah, 11847, Egypt
NCT Number: NCT04905433
As an extension of previous work, in this study, a breathing retraining component is added using breathing calisthenics and inspiratory muscle trainer for the classical cardiac rehabilitation (CR), as an appealing option, to implement a comprehensive rehabilitation protocol addressing the different patient-centered outcomes including different cardiovascular, and respiratory complaints; increasing the benefits of classical CR; detecting the impact of adding this on the cardiovascular (CV) outcomes, and discovering the correlation between the CV and respiratory data.
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Notify Me45 year–65 year
All sexes
Interventional
Not applicable
Cairo, AI Qahirah, 11847, Egypt
A very large number of studies have demonstrated the positive effect of cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) on morbidity and mortality. Globally, each year millions of patients with different cardiovascular diseases (CVD) and chest diseases are enrolled in these programs. The exact effects may be slightly variable, but generally, both CR and PR aim to improve the patient's condition and improve the overall quality of life utilizing almost the same methods (exercise, and education).
Despite these positive effects, utilization rates of either CR or PR are around 30% in Europe, with much less percentages in the Middle East. The reasons for the low engagement rates are many; with most probably the main reasons are about individuality and reach. Optimized CR programs have to be individually tailored; meeting the individual needs of every single patient in the program. Worse knowing that the chest pain and breathlessness are highly prevalent in general in CVD, and considered -in many cases as the chief complaint, and the classical CR programs are neglecting these complaints; negatively affecting adherence rates and patient-centered outcomes (PCO) which mostly extend much beyond the cardiovascular complaints, to extend to the respiratory, and sleep complaints; questioning the reason why breathing retraining methods are not yet considered as an integral part of the CR programs.
The reason that standard CR programs usually neglect these complaints, and only look for the CV outcomes; is considering the other mentioned complaints as "out-of-context". However, solid evidence is suggesting a strong correlation between respiratory, sleep, and CV outcomes.
It has been previously investigated the impact of the CR on sleep, and there is a prior estimate suggesting that 25% of the participants in the CR programs have already sleep disorders, there is a strong correlation between the sleep and CV outcomes, and almost all of the patients in the CR have respiratory symptoms including dyspnea and functional capacity decline.
Therefore, it was suggested adding a breathing retraining component using breathing calisthenics and inspiratory muscle trainer for the classical CR, as an appealing option, to implement a comprehensive rehabilitation protocol addressing the different PCO including different cardiovascular, and respiratory complaints; increasing the benefits of classical CR; detecting the impact of adding this on the CV outcomes, and discovering the correlation between the CV and respiratory data.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling), with a breathing retraining (using breathing calisthenics, and inspiratory muscle training)
A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling) only
Time frame: 12 weeks
represent autonomic response of the heart (measured through a holter ECG)
Time frame: 12 weeks
represents aerobic fitness (VO2 max) (ml/kg/min) measured through cardiopulmonary exercise testing
Time frame: 12 weeks
represents lactate threshold (% of VO2 max) measured through cardiopulmonary exercise testing
Time frame: 12 weeks
represents resting condition of the heart (beat/min)
Time frame: 12 weeks
represents resting condition of the systolic blood pressure (mmhg) measured by sphygmomanometer
Time frame: 12 weeks
represents resting condition of the diastolic blood pressure (mmhg) measured by sphygmomanometer
Time frame: 12 weeks
represents volume of air in a forced expiration after full inspiration (%) measured by pulmonary function testing
Time frame: 12 weeks
represents level of patient exertion on exercise measured by modified Borg scale (1-10), where lower scores means lower levels of exertion, and higher scores means higher levels of exertion.
Cairo University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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