This study was a clinical trial that was performed during the year 2012. In this study, 38 patients, with myocardial infarction that were admitted to the Coronary Care Unit (CCU) of a hospital in Babol city, were selected. The inclusion criteria were as follows; age of less than 75 years old, absence of hemodynamic compromise, absence of atrioventricular block grade II and III, no cardiac complications after AMI, absence of acute psychiatric disorders and movement disorders. The sample size was estimated on the basis of the formula of sample size estimation, with a confidence coefficient of 95% and a test power of 80%; a sample size of at least 24 was estimated, but for more accuracy, sampling was continued until 38 subjects were selected (19 patients in the experimental group and 19 patients in the control group).
In this study, amongst the available patients, individuals with the inclusion criteria were selected by the purposive sampling method, and were randomly allocated to two groups: experimental and control groups. In addition, to control age and sex variables, the randomized block design was used. Thus for age, two states (≤ 60 years and > 60 years) and for sex, two states (male and female) were considered.
In this study, data were collected using two questionnaires. One questionnaire collected the patient’s demographic data (including age, sex, education level, weight, disease background, type of stroke, and patient MI area), and other questionnaire registered the blood pressure and heart rate of the patients. Blood pressure and heart rate of all patients were recorded from the time of admission by a monitoring device (Nihon Kohden device, BSM- 2351K models, made in Japan) connected to the patients; these parameters were recorded every six hours and their means were compared on the first and third day.
Ethical considerations were regarded in this study, so that sampling began after obtaining permission from the ethics committee of Semnan University of Medical Sciences and the hospital and CCU ward authorities. The researcher referred to the relevant ward and selected patients who were suitable for inclusion in the sample. After introducing himself to the samples, the researcher gave them adequate explanation about the research objectives, methods, voluntary participation in the study, and confidentiality of their information. The questions were answered and a written consent was obtained for participation in the study.
In the experimental group, the patient's early mobilization, which was designed by the researchers and based on reliable sources (
5,
15), was performed as follows:
First phase: during this phase the patient, after 12 - 18 hours of admission to the hospital, was moved from lying to sitting position. Following a control of heart rate and blood pressure, in the absence of hemodynamic abnormalities (systolic blood pressure < 100 mmHg and heart rate < 55 beat per minute) and arrhythmias with direct supervision of a researcher, the patient could hang his leg for five minutes, and then got back to the sleeping position.
Second phase: at least three hours after the first phase and resting in bed, following control of heart rate and blood pressure, in the absence of hemodynamic and arrhythmias abnormalities, with direct supervision of a researcher, after hanging his legs, if there was no problem, the patient was allowed out of bed and sat for five minutes on the chair next to the bed and then went back to bed and rested.
Third phase: 24 hours after admission, following control of heart rate and blood pressure, in the absence of problems, under the direct supervision of a researcher, the patient was allowed to sit for 10 minutes on the chair next to the bed.
Fourth phase: at least three hours after the third phase under the direct control and supervision of the researcher, and in the absence of problems, the patient stood for 10 minutes besides his bed, walked and got back to his bed again.
Fifth phase: at least three hours after the fourth stage, after controlling vital signs and absence of problems, under the direct supervision of the researcher, the patient walked beside his bed for five minutes and then under the direct control of the researcher the patient walked in the CCU ward for ten minutes (ten steps out and ten steps back) and got back to his bed again.
Sixth phase: 48 hours after admission, the patient in the absence of problems and under the direct supervision of the researcher, first walked besides his bed for five minutes and then walked around the cardiac intensive care unit for ten minutes (ten steps out and ten steps back) and got back to his bed again.
Seventh phase: at least three hours after the sixth stage, under the direct supervision of the researcher and in the absence of problems, the patient walked for 15 minutes as far as he could bear, around the CCU ward (20 steps out and 20 steps back) and got back to his bed again.
Eighth phase: at least three hours after the previous step, this step was repeated as the seventh step, and if there were no problems in terms of movement, the patient was left in a rest position.
In the control group, patients' mobilization as the ward routine schedule was done 48 hours after admission with the help and supervision of the researcher as follows: on the third day, in the absence of problems, patients were initially transferred from their bed to a chair next to the bed and sat on the chair for a period of five to ten minutes. If there were no problems, they walked besides their bed for five to ten minutes and then went back to their bed. This was repeated twice a day, and the patients were resting during the day on their bed. On the fourth day after admission, in the absence of problems, patients initially walked beside their bed for 15 minutes, and if there were no problems, they walked around the CCU ward for 15 minutes and were then left to rest.
Data analysis was performed with the SPSS software V.16. Descriptive and inferential statistical methods were used. Kolmogorov-Smirnov test (to check data normalization) and independent t-test (to evaluate the difference between means) were used. Data analysis was performed at a significance level of P < 0.05.