[ad_1]
Trial design, participants and setting
This clinical trial is a randomized, pre-posttest, single blind, control group design was conducted on patients with heart failure. Participants met the following criteria: 30–70 years old with class II or class III heart failure, less than 40% ejection fraction, having been diagnosed with heart failure for at least three months, without neurological conditions, vision or hearing difficulties, or severe mental illness, and authorized by their physician to exercise. Patients who did not complete the exercises provided by the application for more than three sessions (one week) or answered fewer than one-third of the questionnaire questions were excluded from the study. This study recruited participants from the Cardiac Rehabilitation Center at Shafa Hospital, an affiliate of Kerman University of Medical Sciences. Patients suffering from joint disease, undergoing cardiac surgery, and having a pacemaker, as well as those with renal failure, received healthcare services at the Cardiac Rehabilitation Center.
Outcomes and measurements
In this study, sleep disturbance was the primary outcome. Researchers also, used sports applications to improve the sleep quality of heart failure patients.
This study evaluated the demographic characteristics and sleep quality of patients. The demographic questionnaire and the Pittsburgh Sleep Quality Index (PSQI) were used to collect data. The demographic characteristics included age, gender, marital status, type of illness, level of education, place of residence, underlying illness, addiction, occupation, medication regimen, and sleep disorders. Basic information was obtained through personal interviews with patients, their family members or other caregivers and their motor ability, vision and hearing impairment were assessed through physical examination.
The PSQI was used to measure the sleep quality of patients in the last month. It included 19 items with seven subscales: sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and sleep medication use. PSQI used a 4-point Likert scale ranging from 0 = no difficulty and 3 = severe difficulty and generated scores according to each domain of the scale. Totaling the averages of the seven factors yields a PSQI score ranging from 0 to 21, with 0–4 indicating “good” sleep and 5–21 indicating “poor,” with the higher total score indicating poorer sleep. As per the authors, a score > 5 indicates a significant disturbance in sleep [14]. The validity and reliability of the questionnaire have been confirmed in the Iranian population [15]. This tool has been used in many studies to measure sleep quality [16, 17]. CONSORT checklist was used to report the research.
Sample size and sampling
Based on a previous study examining the effect of walking at home on improving the quality of life of patients with heart failure, the dropout rate and test power was 80%; the present study considered a sample size of 60 (with 30 participants in each group) for comparing sleep quality between two groups [18]. Following coordination with the hospital and cardiac rehabilitation center heads, the researchers selected eligible patients. The samples were selected using convenience sampling method, and they were allocated into 2 groups by block randomization method. Labels A and B (A = intervention, B = control) were assigned to the groups, and the block size was 4. The randomization list was generated by using free online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists). MD generated the randomization list and MA rzoomand enrolled the participants and assigned them to the two groups.
At first, all the patients with heart failure referred to Shafa Hospital in Kerman who had met the inclusion criteria and were willing to participate were regarded as the research sample. Then, the necessary explanations about the research procedure were given to the samples, and written informed consent was obtained. Based on random block allocation, the eligible patients were divided into two groups. As a result of this method, the number of people assigned to each group is usually almost equal. From 60 eligible patients, 48 (24 in each group) completed the study. The two main reasons for dropouts were: the inability to exercise because of chronic fatigue caused by the disease and failure to answer more than one-third of the questionnaire questions (Fig. 1). The present study is a single-blind randomized clinical trial. Participants was blinded after assignment to interventions.
Explanation of sample size and sampling
Interventions
At baseline, a cardiologist examined participants to ensure they had no medical restrictions. Personal interviews and medical records were used to collect demographic data. The researcher collected data on the sleep quality pattern before and eight weeks after the intervention in both group by the Pittsburgh Sleep Quality Index. One week after the patients’ enrollment, the intervention was conducted. The authors coordinated and monitored their exercise adherence by calling them on a predetermined schedule. Immediately after baseline data collection, randomized participants to the intervention group participated in the sports application intervention. For eight consecutive weeks, participants exercised three times per week. Also, participants were prohibited from improving or disturbing their sleep quality or reading materials related to sleep. In order to design and develop the application, the researchers met with a cardiologist and two medical informatics experts. In addition, ten faculty members approved the educational content before the study. Several stages of the review were conducted during the development of the application for a year. A team of experienced IT engineers, programmers and graphic designers worked together to develop the application. The application was finally approved in August 2021. The application was piloted with ten patients before the study, and any potential problems were resolved. The researcher trained patients and their families in the use of the application prior to the study under the supervision of a cardiologist. The authors provided an explanation of how to use the application. This sports application included texts, podcasts, and educational videos regarding sports movements and conditions for starting and stopping sports. There were two parts to this application providing recommendations before engaging in sports and sports exercises, which will be discussed in the following paragraphs. Before each session at home, it is important to observe the following points: conducting sports in a balanced climate (not too cold or too hot) is important, exercise as desired (in the morning after breakfast or in the evening after dinner), When performing sports in public places, it is advisable to wear a mask when exercising, it is advisable to carry sweet food with you, do not continue exercising if you are experiencing severe shortness of breath, an abnormally high heart rate, excessive fatigue, or chest pain. Sports exercises: the warm-up exercise was made as an animation and included five sports movements in a two-minute educational clip. The walking exercise consists of 30 min of aerobic walking based on the patient’s physiological capabilities. After the patients had been able to perform the exercises for 15 min for two consecutive weeks, they were added 5 min to their training every two weeks until a maximum of 30 min was reached at the end. The cool-down exercise included four soft movements presented as educational clips (animation), as summarized in Table 1. To monitor adherence to exercise, the researcher called each participant three times a week on predetermined days. Depending on the patient’s educational needs and questions, the duration of the phone call varied. In total, he made 24 telephone calls to each patient. Control group participants received drug therapy for sleep disorders, which is the usual treatment. This study lasted five months, from August 2021 to January 2022.
Statistical methods
We analyzed the data using descriptive and inferential statistics by SPSS 25. In order to describe participants’ characteristics and other variables, descriptive statistics (frequency, percentage, mean, and standard deviation) were used. Participants’ characteristics in the intervention and control groups were compared using independent t-tests, chi-squared tests, and Fisher’s exact tests. Considering the normal distribution and Levene’s Test of Equality of Error Variances were fulfilled, Analysis of covariance (ANCOVA) was used to compare the sleep quality score between the two groups after the intervention. In addition, paired t-tests were used for within-group comparisons. This research considered a 95% confidence level, p-value = 0.5.
[ad_2]
Source link
