The current 2-group randomized, crossover trial was conducted on elderly people referred to healthcare centers in Rafsanjan, Iran. Based on the results of an earlier study (
26) and the formula to calculate sample sizes to compare 2 means, 18 cases were needed for each study group. Yet, the sample size was increased to 25 for each group to enhance the rigor of the study and prevent the effects of probable dropouts on the study results.
Inclusion criteria were the age of 60 or above, adequate physical strength and fitness to walk, no affliction by cardiopulmonary or mental disorders; no history of drug addiction, cigarette smoking, hypertension, and arthralgia; no history of regular physical exercise during the past 2 months; no use of sleeping medications; and a score of 5 or more for the Pittsburg sleep quality index (PSQI). Participants were excluded if they developed physical problems during the study, were unable to go walking, or had 2 consecutive or 4 intermittent absentees from the walking sessions.
A demographic questionnaire and PSQI were used to gather data. As a valid and reliable self-report tool, PSQI was developed by Buysse et al. to assess sleep quality and diagnose sleep disorders during the past 4 weeks (
10). PSQI contains 9 items in 7 components as follows: subjective sleep quality: item 9; sleep latency: item 2 and part “a” of item 5; sleep duration: item 4; habitual sleep efficiency: the score of this item is calculated through dividing the hours spent asleep by the time spent in bed and multiplying the result by 100; sleep disturbances: the mean score of all parts of item 5; sleeping medication: item 6; and daytime dysfunction: items 7 and 8. Each item is scored by a 4-option Likert scale for normal, mild, moderate, and severe sleep problems. The total score of PSQI is calculated through summing up the item scores and can range from 0 to 21 (
6). According to PSQI developers, PSQI scores greater than 5 are interpreted as poor sleep quality, while scores 5 and lower show good sleep quality. The Cronbach’s alpha of PSQI is 0.83 (
10).
In total, there were 276 eligible elderly people in the study setting; 50 were selected and randomly allocated into morning-evening (ME) and evening-morning (EM) groups. In the first phase of the study, participants in the ME and the EM groups, respectively, went on morning and evening walks for 4 consecutive weeks. Thereafter, they were asked to avoid any sort of regular walking for 4 consecutive weeks. This 4-week rest was considered as the washout period. In the second phase, i e, after the washout period, the intervention was reversed and participants in the ME and the EM groups, respectively, went on evening and morning walks for 4 weeks. This crossover design helped to minimize the effects of confounders and do the study with smaller sample size. Walking sessions were held 3 times a week. Each session consisted of warm up exercise (3 to 5 minutes), walking (30 minutes), and cool-down exercise (3 to 5 minutes). Morning and evening walk sessions were held at 08:00 - 09:00 AM and 04:00 - 05:00 PM, respectively. All sessions were held in a city park and were managed and coached by the first author and a fitness coach. PSQI was completed for participants by a research assistant at 4 assessment time points, namely before the intervention, immediately after the first intervention, immediately after the washout period (i e, before the second intervention), and immediately after the second intervention.
Before the intervention, informed consent was obtained from all participants based on the requirements of the ethics committee and the institutional review board of Rafsanjan University of Medical Sciences, Rafsanjan, Iran. Moreover, participants were adequately informed about the objectives of the study and the confidential management of the study data. The current study was registered in the Iranian registry of clinical trials (No. IRCT2016030826965N1) and approved by the ethics committee of Rafsanjan University of Medical Sciences, Rafsanjan, Iran (No. IR.RUMS.REC.1394.185).
In total, 6 participants from the ME group and 7 from the EM group were excluded due to their irregular attendance at walking sessions. Therefore, final data analysis was carried out on the collected data from 37 participants (19 in the ME and 18 in the EM groups) (
Figure 1). Participants were 23 females and 14 males. Collected data were transferred into the SPSS software version 18.0 and described using the measures of descriptive statistics (such as mean and standard deviation (SD). The Chi-square and the independent-samples t tests were used for intergroup comparisons while the paired-samples t test and the repeated-measures analysis of variance (ANOVA) were performed for intergroup comparisons. Moreover, crossover analysis was performed to compare sleep quality scores in the 2 groups (
27), and carry-over effect was calculated to evaluate the residual effects of the first intervention on the results of the second intervention. Significance level for all statistical tests was 0.05.
The Flow Diagram of the Study