Study design
This was a single-center, parallel (Intervention Group (IG) and Control Group (CG)) randomized controlled clinical trial, with an allocation ratio of 1:1, and single-blind (evaluators). The project was conducted in the University of São Carlos (UFSCar) of the Brazil, located in the city of São Carlos, in 2021 and 2022. The project complied with CONSORT (2010).
Ethical approval and Consent to Participate
The Ethics Committee of UFSCar approved the experiment (34350620.7.0000.5504). The informed consent was obtained from all subjects. Also, the work was included in the Brazilian Registry of Clinical Trials (REBEC) in 25/09/2020 and updated in 2023 with the number RBR − 3t85fd.
Participants
The inclusion criteria were as follows: older people who had a history of at least 2 falls in the past 12 months, who were able to walk alone with or without walking aids, were available to participate in evaluations and interventions, who scored on the Mini Mental State Examination (MMSE) below the cutoff point for education level6 and/or scored in Addenbrooke's Cognitive Examination– Revised (ACE-R) below 78 points7. Participants were also required to have access to virtual communication with audio and camera or have a family member with access and familiarity with virtual communications to enable the proposed evaluations and intervention.
The exclusion criteria were as follows: older people with severe and uncorrected auditory or visual disturbance that hindered communication during evaluation and interventions, with motor sequelae of stroke, active inflammatory diseases (acute, uncontrolled), Parkinson's disease in the advanced stages, multiple sclerosis, Huntington’s disease, dementia, uncontrolled vestibulopathy, epilepsy and traumatic brain injury or who were taking medications that indicate the presence of these diseases.
The study included an initial evaluation, a final evaluation after 16 weeks of interventions and a follow-up evaluation after 6 weeks. The evaluations and interventions were performed remotely through video calls on WhatsApp or Google Meet, according to the access and preference of each participant. The participants were divided into two groups (CG, IG), and their randomization was performed by a researcher who was not involved in the recruitment, evaluations or interventions.
The participants allocated to the CG were encouraged to maintain their routine and were monitored monthly regarding their general health, in addition to completing a falls calendar.
Intervention
The IG was subjected to case management through weekly calls. In the 1st week, a multidimensional evaluation was performed, which included screening of the main risk factors for falls. In the 2nd week, the case managers explained the risks identified for each participant and his or her caregivers and the proposed interventions, in addition to encouraging participants to adhere to the physical and cognitive exercise program. In the 3rd week, an individualized fall intervention plan was developed with the help of the elderly person, taking into account the priority fall risk treatments and the individual’s personal preferences. From the 4th to the 16th weeks, the plan for the participant was put into practice, with the necessary guidelines and recommendations. Detailed information about the protocols are available8,9.
The physical exercise program consisted of a warm-up, muscle strengthening, balance exercises and stretching. The determination of the muscle strengthening load was assessed using the Borg CR-10 Scale9. In the 1st week, familiarization of the exercises was performed, and in the following weeks, videos were sent so that the volunteers could perform at the times they preferred. They also received calls every 15 days to answer possible doubts, make corrections and progressions8,9. The cognitive stimulation program consisted of memorization strategies, interactive games, attention and concentration strategies, conversation circles about memory loss, health education actions and blood pressure measurement and monitoring. The intervention occurred over the course of 16 weeks in 2 weekly meetings for monitoring and elimination of doubts regarding the performance of activities8,9.
Assessment
Muscle strength, mobility and balance were assessed using the Brazilian version of the Short Physical Performance Battery (SPPB), which consists of three tests: balance tests, gait speed test and stand-up test10. Mobility was also assessed by TUG and dual-task TUG, which aimed to evaluate postural control systems and mobility11. The Manchester index of disability associated with foot pain in the elderly population was used12. Safety at home was assessed using the Home Falls and Accidents Screening Tool (HOME FAST) to identify the risk factors for falls and domestic accidents13. The evaluation of footwear was performed according to the environmental assessment and risk of falls14, which describes the use of footwear most used during the night and day by elderly individuals. In addition, the participant showed the model of footwear most used by them daily15.
All the assessments were recorded and the volunteer could request a copy of the videos at any time during the study. The storage files with the recordings of the evaluations were stored in Google Drive (virtual file storage service) at the Magic Program, where this research took place. Only the researchers who carried out the assessments and the teachers coordinating the research have access to check the information, if necessary. The security of the videos is guaranteed by Google and access to them is only granted through two-step authentication, which makes it difficult for hackers to gain access.
Data Analysis
A significance level of α = 0.05 was adopted, and SPSS software (22.0) was used to perform the statistical tests. The analysis was performed by intention-to-treat. The Kolmogorov‒Smirnov normality test was applied to all continuous variables to verify data distribution. The chi-square test of association was used for categorical variables to compare groups regarding clinical and sociodemographic characteristics. The independent t test was used for continuous variables with a normal distribution. Two-way ANOVA was used to test the interaction between groups and moments. In case there was interaction, analyses of simple main effects were performed, with adjustment for multiple comparisons (Bonferroni). In the sample size calculation, an effect size of moderate magnitude (0.2) was delimited16.