Data collection
Data will be collected from the baseline and follow-up physical assessments, monthly falls diaries, telephone contacts and medical and expert reports. The assessments will be conducted by independent, trained health care professionals who will not be providing the interventions and that will be unaware of the participants study group allocation. Participants will be instructed not to inform the assessors of their intervention status. Assessors will complete a questionnaire to assess their perception of the participants’ group allocation, in order to test the success of assessor blinding. The assessments will include questionnaires, physical examination and physical performance tests. All participants will undergo three assessments: the first at baseline prior to randomisation, the second and third at 6 and 12 months after commencement of the intervention respectively.
Primary outcome measures
The primary outcome will be the rate of falls and the proportion of fallers in 12 months after randomisation. Participants will receive instructions to fill in a monthly fall diary. They will receive telephone calls each month to ask for information regarding falls and their consequences, such as the mechanisms, environmental conditions, location (indoors or outdoors), activity during the fall and injuries sustained.
Secondary outcome measures
Secondary outcome measures will be the risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, health services use and difficulty with daily tasks. These outcome measures are described below.
Fall-related self-efficacy will be assessed with the
Falls Efficacy Scale International[
28], translated and adapted in its Brazilian version [
29], which consists of a questionnaire with16 activities in which the participant rates, on a 4-point scale their degree of concern about the possibility of falling while carrying out the activities. It measures their degree of self-efficacy to avoid falling.
Balance mobility and strength will be measured by the:
Berg Balance Scale[
30‐
32],
Alternate Step test[
31],
Sit to stand Test[
33,
34]
and Hand grip strength[
35,
36]. The Berg Balance Scale consists of 14 common tasks involving static and dynamic balance, such as reaching, turning, moving, standing and getting up. Ability to perform the tasks is graded from 0 to 4, with an overall maximum score possible of 56 points, and higher scores indicating better balance. The
Alternate Step test[
31] requires the participant to stand in front of an 18-cm high step or stool and at a verbal command the participant taps the whole foot (shoes removed) onto the step, and alternates with the right and left feet, for a total of eight repetitions as quickly as possible. The time taken to complete the task is the score. The
Sit-to-stand test will be used to primarily assess lower limb strength. There will be a pre-test which involves the patient moving from sitting in a chair to a standing position without the assistance of their hands. If the subject can perform this movement, they will be instructed to repeat the test, as quickly as possible, five times consecutively with their upper arms crossed over their chest. The time taken to perform this task will be recorded.
Hand Grip strength will be assessed using a portable hand dynamometer (SAEHAN® model SH5001). The participant will be seated with their shoulder in a neutral position and their elbow flexed at 90°.Three attempts will be performed alternately in each hand; the mean of the three measures will be recorded.
Fall risk will be assessed using the
QuickScreen Clinical Falls Risk Assessment[
37], a validated instrument consisting of five physical performance items, two questions about medications and one about previous falls. An individual’s estimated fall risk will be considered to have decreased if, upon retest, they have moved down to the next level in the risk categories proposed by Tiedemann et al. [
37]. The risk categories and their associated probabilities of future falls are as follows: for 0–1 QuickScreen items, the probability of falling is 7%, for 2–3 items the probability of falling is 13%, for 4–5 items the probability of falling is 27% and for 6 or more items the probability of falling is 49%.
The level of difficulty with daily tasks will be assessed using the Brazilian OARS Multidimensional Functional Assessment Questionnaire (BOMFAQ) adapted from the Older Americans Resources and Services (OARS) [
38] instrument that measures self-reported difficulty while performing 15 daily activity tasks: eight activities of daily living : lying down and getting up from bed, eating, combing hair, dressing, bathing, walking on a uneven surface, getting to the toilet in time, cutting toenails and seven instrumental activities of daily living: taking medications, climbing stairs, walking near home, preparing meals, taking public transport, shopping and cleaning the house, hierarchically organized. The number of activities performed with difficulty will be summed and categorized as follows: 0, 1 to 3, 4–6 or 7 or more activities.
Services use will be measured by the number of fall-related visits to emergency departments and hospitalisations (frequency and duration) per participant.
Compliance with the home exercise program (frequency and duration) will be recorded in a home exercise diary. Adverse side effects will be measured with an adverse events form, including stiffness, pain, fatigue, etc. At the end of the follow-up period participants will be asked to identify reasons for non-adherence on the home-based exercise program.