Santaularia 2013.

Trial name or title	Randomised clinical trial to evaluate the effect of a supervised exercise training program on readmissions in patients with myocardial ischemia: a study protocol
Methods	Study design: Single centre RCT Country: Spain Dates patients recruited: not stated Maximum follow up: 1 year
Participants	Inclusion criteria: age over 18; diagnosis of MI (myocardial ischemia, pre‐infarct angina, cardiac angina, other specific forms of chronic ischemic heart disease or unspecified ischemic heart disease) in the current admission; residence in the catchment area of our hospital; absence of cognitive deficit (Pfeiffer test: 0–2 mistakes); sufficient autonomy to follow the cardiac rehabilitation programme (Barthel index >60); willingness to participate in the study. Exclusion criteria: Patients will be excluded if: they have symptoms of right heart failure producing pulmonary hypertension or dyspnea caused by severe pulmonary pathology; additional comorbidities affecting the prognosis of cardiac disease; major comorbidities or limitations that could interfere with exercise training programme; cognitive impairment; or if they do not provide informed consent.
Interventions	Intervention: In addition to the usual hospital care, patients randomised to the intervention group will be provided with a supervised outpatient exercise training programme, according to the results of the exercise stress test performed one month after hospital discharge and bearing in mind the physical limitations imposed by co‐morbid conditions. The programme will be performed in the hospital and it will start within the three days after the exercise stress test. It will comprise three hours a week (spread over three alternate days) of supervised exercise training for 10 weeks. The intervention will end after 10 weeks, regardless of whether the patients have completed 30 sessions. Exercise classes will be supervised by a physiotherapist and will consist of 10 minutes of warm‐up and muscle stretching, 30 minutes of aerobic exercises (cycloergometer), 15 minutes of isotonic exercises for the upper and lower extremities and 5 minutes of cool‐down. Moreover, instructions will be given on self‐pulse counting, subjective perception of effort using the Borg scale, relaxation exercises, breathing techniques, postural health and minimising physical effort. Aerobic exercise intensity will be between 75‐90% of the maximum heart rate obtained in the previous exercise stress test and progressing according to the rating of perceived exertion (RPE: Borg scale 11–15). Resistance training will be performed with 10–15 repetitions for three sets, maintaining an RPE of 11–14. The physiotherapist will check that patients are exercising at their prescribed intensity with a pulse oximeter (Quirumed® Health & Care). Components: exercise only. Setting: supervised group sessions at the hospital. Aerobic exercise: Modality: cycloergometer. Length of session: 1 hour. Frequency: 3 sessions per week. Intensity: 75‐90% of the maximum heart rate (RPE: Borg scale 11– 15). Resistance training included? Yes. Total duration: 10 weeks. Co‐interventions: After hospital discharge, patients in both groups will have scheduled follow‐up visits with a cardiac nurse at the first month, and then after 3, 6 and 12 months (visits 1, 2, 3 and 4 respectively) since hospital discharge in order to control the risk factors, reinforce education for disease control and review adherence to cardiac medication and CRP follow‐up. Comparator: The control group will receive the standard care given at the hospital. Co‐interventions: Patients will receive verbal and written information on cardiovascular risk factors from the cardiac nurse or the physiotherapist. Hospitalised patients will be instructed to do exercises to regain mobility in order to maintain and improve muscular tone and peripheral circulation, and will be taught breathing exercises by the physiotherapist to improve their breathing patterns. Before discharge, the physiotherapist will instruct patients on how to return to physical activity. After hospital discharge, patients in both groups will have scheduled follow‐up visits with a cardiac nurse at the first month, and then after 3, 6 and 12 months (visits 1, 2, 3 and 4 respectively) since hospital discharge in order to control the risk factors, reinforce education for disease control and review adherence to cardiac medication and CRP follow‐up.
Outcomes	Mortality, MI, hospitalisations, HRQL.
Starting date	Not stated.
Contact information	Núria Santaularia; nsantaul@althaia.cat
Notes	The author was contacted and replied that the results would be published shortly.