Aquatic exercise protocol on falls

Journal Pre-proof

Aquatic exercise training for falls and potentially modifiable risk

factors of falls in older people: a blinded randomized controlled trial
protocol

Daniela Lemes Ferreira , Dayane Melo Campos ,

Verena Vassimon-Barroso , Jessica Cerutti , Ianne Sousa Souza ,
Gustavo Christofoletti , Juliana Hotta Ansai

PII: S1876-3820(20)31395-0
DOI: https://doi.org/10.1016/j.eujim.2020.101214
Reference: EUJIM 101214

To appear in: European Journal of Integrative Medicine

Received date: 15 May 2020

Revised date: 25 September 2020
Accepted date: 26 September 2020

Please cite this article as: Daniela Lemes Ferreira , Dayane Melo Campos ,
Verena Vassimon-Barroso , Jessica Cerutti , Ianne Sousa Souza , Gustavo Christofoletti ,
Juliana Hotta Ansai , Aquatic exercise training for falls and potentially modifiable risk factors of
falls in older people: a blinded randomized controlled trial protocol, European Journal of Integrative
Medicine (2020), doi: https://doi.org/10.1016/j.eujim.2020.101214

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Aquatic exercise training for falls and potentially modifiable risk factors of falls in
older people: a blinded randomized controlled trial protocol

Aquatic exercise protocol on falls

Daniela Lemes Ferreiraa; daniela_lemes@hotmail.com; +55 16 3306-6666; ORCID ID

0000-0001-6593-8567
Dayane Melo Camposa; dayanecampos2824@gmail.com; +55 16 3306-6666; ORCID ID
0000-0003-2220-0292
Verena Vassimon-Barrosob; verena.vassimon@gmail.com; +55 16 3306-6666; ORCID ID
0000-0001-8322-4023
Jessica Ceruttic; jessie.cerutti200598@gmail.com; +55 16 3306-6666; ORCID ID 0000-
0001-7528-0551
Ianne Sousa Souzac; iannesousasouza@gmail.com; +55 16 3306-6666; ORCID ID 0000-
0001-9415-3195
Gustavo Christofolettia,c, g.christofoletti@ufms.br; +55 16 3306-6666; ORCID ID 0000-
0002-7879-239X
Juliana Hotta Ansaia,b; jhansai@ufscar.br; +55 16 3306-6666; ORCID ID 0000-0001-9873-
3509

a
Movement Science Graduate Program, Integrated Institute of Health, Federal University of
Mato Grosso do Sul, Costa e Silva Avenue, postal code 79070-900, Campo Grande, Mato
Grosso do Sul, Brazil.
b
Department of Gerontology, Federal University of São Carlos, Rodovia Washington Luiz,
km 235, postal code 13565-905, São Carlos, São Paulo, Brazil.
c
Department of Physical Therapy, Integrated Institute of Health, Federal University of Mato
Grosso do Sul, Costa e Silva Avenue, postal code 79070-900, Campo Grande, Mato Grosso
do Sul, Brazil.

Correspondence:
Juliana Hotta Ansai
Department of Gerontology, Federal University of São Carlos, Rodovia Washington Luiz,
km 235, postal code 13565-905, São Carlos, São Paulo, Brazil.
+55 16 3306-6666;
Email address: jhansai@ufscar.br
Wordcount: 4021
Abstract

Introduction: There is a lack of randomized clinical trials involving hydrotherapy to prevent

falls in people aged 65 years and over. This trial aims to verify the effects of hydrotherapy

on falls and potentially modifiable risk factors of falls in community-dwelling people aged

65 years and over. Methods: A single-blind randomized controlled trial will be conducted

with 60 people aged 65 years and over, without cognitive impairment. The participants will

be randomly allocated to one of two groups (Hydrotherapy Group and Control Group). The

Hydrotherapy Group will perform a multicomponent protocol consisting of a warm-up,

muscular resistance and activation, balance, aerobic capacity, and cool-down exercises. The

Control Group will not perform any intervention. The Hydrotherapy training will have

progressive intensity, lasting 16 weeks, and will include two 1-hour sessions per week on

non-consecutive days. All participants will be assessed at baseline, after 16 weeks of

training, and after 6 weeks of detraining. The assessment will consist of medical history,

neuropsychological measures (cognitive functions, depressive symptoms, fear of falling,

behavior), and motor measurements (muscle strength, balance, mobility). In addition, the

occurrences of falls will be collected over 22 weeks through a falls calendar and monthly

phone calls to verify the effects of training and short- term detraining. Results: We expect

that the aquatic multicomponent exercise protocol associated with dual tasks will reduce

fall rates and improve some motor and neuropsychological risk factors compared to the
Control Group after training and short-term detraining. Conclusions: Hydrotherapy

warrants investigation as a falls prevention strategy in older people.

Clinical trial registration: REBEC (RBR-48z4vp).

Keywords: aged; falls; neuropsychological tests; physical exercise; postural balance.

Introduction

The increase in life expectancy implies a greater likelihood of chronic diseases and

adverse events, such as falls [1]. Approximately 30 to 40% of community-dwelling people

aged 65 years and over fall at least one time per year [1]. As this event is considered a

public health problem with great social impact, its prevention is essential among this

population [2].

According to the most recent Cochrane update on exercise for preventing falls in

community-dwelling people aged 65 years and over, group exercise programs can reduce

both the rate and risk of falls [2]. Sherrington et al. [2,3] recommend that physical exercise

protocols should be challenging for balance and have progression of intensity and

continuous participation to prevent falls in people aged 65 years and over. Among the

different types of physical exercise, hydrotherapy may represent an option to reduce the

risk of falls, although there is a lack of studies involving this type of intervention [2,3,4,5].

In a systematic review, Waller et al. [4] found an overall positive effect of water-based

exercise with moderate to high intensity on physical functioning in people aged 50 years

and over. However, few studies included in the systematic review worked with important

risk factors for falls, such as postural stability and neuropsychological measures. There is a

need for more clinical trials involving aquatic exercise protocols of good methodological
quality to verify the effects of these protocols on risk factors for falls and falls in people

aged 65 years and over, taking into account that a fall is a multifactorial event [4].

The aquatic environment provides situations of instability and challenges to the center

of gravity through turbulence and other water properties, thus promoting improvements in

body balance reactions [4]. In addition, hydrotherapy in the pool is safe for people aged 65

years and over, with no adverse effects of physical exercise reported such as falls, injuries,

and fear of falling [4,5]. In contrast, adverse events of physical exercise to prevent falls

have been little reported in the literature. When reported, adverse events of physical

exercise on the ground involve mainly non-serious musculoskeletal events [2].

Moderate to high intensity hydrotherapy has positive effects on motor abilities, such

as muscle strength and gait, in healthy adults [4]. Positive effects of hydrotherapy were also

found on overall cognitive function, attention, memory, and learning in community-

dwelling people aged 65 years and over, when cognitive stimuli were included in the

intervention [5]. Moreover, despite the lack of studies on the theme these types of

intervention can be at least as effective as physical exercise protocols on the ground [4,5].

Although there is evidence of the benefits of physical activity for falls prevention in

community-dwelling people aged 65 years and over [2], there is a limitation in the literature

regarding randomized controlled trials with good methodological quality and adequate

sample sizes on the effects of hydrotherapy on fall rates and their potentially modifiable

risk factors. Furthermore, the effects of detraining in people aged 65 years and over have

not yet been defined.

The present water-based physical exercise protocol is innovative in the literature, and

was based on previous protocols and recommendations, such as the recommendations of

physical exercise for older adults of the American College of Sports Medicine [6], clinical
trials included in systematic reviews involving risk factors for falls and aquatic exercise

[4,5,7], and pilot interventions of this research group.

This clinical trial aims to verify the effects of a hydrotherapy protocol on falls and

potentially modifiable risk factors in community-dwelling people aged 65 years and over

after 16 weeks of training and 6 weeks of detraining. It is hypothesized that hydrotherapy

will decrease fall rates and improve some risk factors, especially motor measures,

compared with the Control Group. After the short-term detraining, it is expected that

neuropsychological and motor measures related to risk of falls will be maintained.

Materials and Methods

Trial design

A unicenter, randomized block design (allocation ratio 1:1), single-blind, parallel-

group controlled trial will be conducted in Brazil at three assessment times (baseline, after

16 weeks of training, and after 6 weeks of detraining) (Figure 1). The participants will be

allocated to a hydrotherapy group (n = 26) and a control group (n = 26). The study will be

conducted at the Federal University of Mato Grosso do Sul (UFMS). This trial follows the

2010 CONSORT [8] and 2013 SPIRIT [9] recommendations.

The study was approved by the UFMS Research Ethics Committee (3.177.309/2018)

and registered in the Brazilian Registry of Clinical Trials (REBEC) (RBR-48z4vp). The

participants will sign the Informed Consent Form.

[Insert Figure 1 here]

Participants
 Eligibility criteria will be people aged 65 years and over, resident in the city of

Campo Grande (MS-Brazil), non-institutionalized, and with the possibility of contact via

telephone. The participants will be recruited from health units and via advertising on

communication networks, local leaflets, posters, and radio channels.

For inclusion criteria, the people aged 65 years and over will be required to be able to

walk alone with or without walking aids, report availability to attend the training site twice

a week, and willingness to participate in a random survey. Exclusion criteria will be: any

absolute contraindication described by the Physical Activity Readiness Medical

Examination[10]; participation in regular and standardized physical activity (walking,

running, cycling, swimming, aerobic exercise, dancing, gardening, or weightlifting) two or

more times a week [11]; a Mini-Mental State Examination (MMSE) score below the cut-off

point according to level of education (28 points for people with over 7 years of schooling,

24 points for 4-7 years of schooling, 23 points for 1-3 years of schooling, and 19 points for

illiterate people) minus one standard deviation [12]; motor sequelae of stroke and

neurological diseases that could interfere with cognition or mobility (Parkinson's disease,

Multiple Sclerosis, Huntington's disease, dementia, vestibulopathy, epilepsy, and traumatic

brain injury); and a severe and uncorrected audiovisual disorder that hinders

communication during assessments. The presence of contraindications will be collected

through report by the participants and their relatives. Finally, the participant will be

required to present a medical certificate of fitness for hydrotherapy.

Intervention

The Control Group will not perform any intervention. The Hydrotherapy Group

training will last 16 weeks, with two 1-hour sessions per week, on non-consecutive days.

The researcher who conducts the intervention will be properly trained. The trial will follow
safety considerations for participants before and after the intervention, according to the

World Health Organization [13]. The physical environments for assessment and

intervention will be safe, with non-slip flooring and side bars. The pool used will have a

ladder with bar support and bars along the entire edge of the pool. Participants will not be

alone at any time during the procedures and will always be supervised regarding their

physical and emotional health. Before and after each session, blood pressure and heart rate

will be measured for the participants' safety. A week of familiarization will be provided for

better adaptation to the training and aquatic environment.

The Hydrotherapy Group will perform multicomponent training (Table 1), involving:

5 minutes of warm-up (walking in different directions with increased speed, flexion and

trunk rotation exercises); 20 minutes of resistance and muscle activation exercises focusing

on the main muscle groups of the trunk and lower limbs and associated cognitive tasks

(three sets of 12 repetitions, 1 minute of rest between sets, intensity checked every week

and maintained between 5-7 points on the Modified Borg Effort Perception Scale-BORG-

CR10) [14]; 15 minutes of balance exercises (semi-static exercises, walking on a line,

overcoming and avoiding obstacles, with increased difficulty through reduction in sensory

inputs and support base, increased complexity of movements, and addition of motor and

cognitive tasks) [7]; 10 minutes of aerobic exercises (stationary running and swimming

with progression of intensity checked every week and maintained between 5-7 points on the

BORG-CR10) [14]; and 5 minutes of cool-down (stretching of trunk and lower limbs,

lasting 30 seconds each, and deep breathing). During the intervention, if there is any

adverse event, such as cramps, malaise and hypotension, it will be recommended the stop

of activity immediately. If necessary, the progression of the exercise will be reversed, the

participant will be removed from the pool and he/she will receive necessary care. The
intervention will be returned only after total improvement. After 16 weeks of training,

participants will undergo 6 weeks of detraining. During this period, all participants will be

instructed to perform their routine as usual.

[Insert Table 1 here]

Outcomes

Participants will be instructed to wear comfortable clothing and appropriate shoes, eat

at least one hour before, and not perform vigorous exercise the day before the assessment,

and bring hearing and visual aids, if necessary.

Assessments will be performed at baseline, after 16 weeks of training, and after 6

weeks of detraining, consisting of medical history with clinical and sociodemographic data

(age, sex, years of schooling, medication use, morbidities, history of falls, presence of

orthostatic hypotension, and level of physical activity [15]), falls data, and

neuropsychological and motor measures. The tests will be applied in a closed environment

with minimal visual and auditory stimuli. The evaluators will be properly trained. All tests

will be explained clearly to the participants and before starting data collection pilot

evaluation and intervention tests will be performed.

Primary outcome measures

Global cognition and dual task measures related to falls are the primary outcomes of

this trial, which will be collected at baseline, after 16 weeks of training, and after 6 weeks

of detraining. Global cognition will be assessed by the Addenbrooke's Cognitive

Examination-Revised (ACE-R). The ACE-R consists of a brief cognitive assessment

battery ranging from 0 to 100 points. The score is divided into six cognitive domains:

orientation and attention, memory, verbal fluency, language, and visuospatial skills [16].
 Dual task performance will be assessed by the time spent on TUG associated with a

cognitive-motor task (TUG-DT). The secondary task was chosen because it involves

executive functions and is functional and challenging. Initially, the isolated cognitive-motor

task will be performed. A drawn raffle card containing eight numbers will be fixed on a

cordless telephone placed on a table (68.5-cm high). While seated on a chair 45-cm high

with trunk support and arm rests in front of the table, the participant will be instructed to

pick up the telephone, dial the numbers, and place the phone on the table [17]. After the

isolated cognitive-motor task, the TUG will be performed. After completing both tasks, the

TUG-DT will be performed. With a new drawn card, containing eight numbers and fixed

on the phone, the participant will be instructed to get up from the chair, walk to the table

placed 50-cm away from the chair, pick up the cordless phone, continue walking while

dialing the numbers, return the phone to the table, walk to the chair and sit down. Total

time spent on TUG-DT will be collected [17]. Prior to all tests, the evaluator will perform

one demonstration and the participant will perform one familiarization attempt.

Secondary outcome measures

Other neuropsychological and motor measures related to falls, presence of falls and

body mass index are the secondary outcomes of this trial, which will be collected at

baseline, after 16 weeks of training, and after 6 weeks of detraining. Regarding

neuropsychological measures, cognition will be assessed by the MMSE score, Verbal

Fluency Test, Clock Drawing Test and Battery Assessment Frontal (BAF). The MMSE

score, Verbal Fluency test (number of words beginning with the letter “P” and number of

animals recalled in one minute) and the Clock Drawing test [18] will be extracted from the

ACE-R. The BAF was developed to detect changes in executive functions associated with
functioning of the frontal cortex. It has a maximum total score of 18 points and is an easy

and fast instrument to apply in people aged 65 years and over [19].

Behavioral symptoms will be assessed using the abbreviated Geriatric Depression

Scale (GDS), the Falls Efficacy Scale-International (FES-I), and the Cardioemotion device.

The abbreviated GDS has a sensitivity of 86.8% and a specificity of 82.4% for depressive

symptoms [20]. Fear of falling will be assessed by the FES-I. A score greater than or equal

to 23 points is associated with sporadic falls, while a score greater than 31 points is

associated with recurrent falls [21]. The Cardioemotion device provides cardiovascular

biofeedback that can be used for mental health assessment and training. This is a

resonance-mediated physiological self-modulation technique between two cardiovascular

regulation mechanisms (baroreceptor reflex sinus respiratory arrhythmia). For data capture,

a non-invasive sensor is placed on the fifth finger. Heart beats are captured and transmitted

to a computer program that evaluates heart cycles and RR intervals and calculates heart rate

variability [22].

Regarding motor measures, muscle strength will be assessed by the Five-times Sit-to-

Stand test. Initially, the participant will be asked to cross their arms on their chest and stand

up from the chair once. If the participant is able to perform the pretest, they will be

instructed to stand up and sit down as quickly as possible five times. The time taken to

perform the test will be recorded (seconds) [23]. Balance will be evaluated by stabilometry,

which analyzes balance by quantifying body oscillations, through center of pressure (COP)

displacements, using a Force Platform (EMG System of Brazil, SP, Ltda) [24]. The

participant will be asked to remain in an upright position with the feet parallel and the

distance between the feet similar to the individual pelvic width [25]. Four conditions will
be studied: (1) standing posture looking at a target 51-cm away, arms beside the body and

feet together; (2) standing posture with eyes closed, arms beside the body and feet together;

(3) standing posture looking at the target, arms beside the body and feet in tandem position;

(4) standing posture with eyes closed, arms beside the body and feet in tandem position.

There will be one 60-second trial in each condition, with a 1-minute interval between them.

The stabilometric parameters analyzed will be the average range of COP displacement in

the anteroposterior and lateral axis, the average velocity and the elliptic area of COP

displacement in the platform plane. The data collected on COP will be analyzed using

BIOMEC 400 (EMG System Brazil, SP, Ltda).

Mobility will be assessed by the Timed up and Go (TUG) test and by other

parameters of the TUG associated with a cognitive-motor task (TUG-DT). Correct answers

and errors and time spent on the isolated cognitive-motor task will be marked, with an error

being considered if the participant dials an incorrect number or forgets a number [26]. Also,

total time spent on TUG, number of steps, stops (defined when the individual has no

intention of progressing the locomotion), correct answers and errors in the TUG-DT will be

collected [26].

Regarding falls, the participant will be asked about the presence of falls in the

previous six months. Falls will be defined as “an event that results in a person coming

inadvertently to rest on the ground or other lower level and not the result of a violent blow,

unconsciousness, sudden onset of paralysis or epileptic seizure”[27]. The participant will

also be asked to explain how the event occurred, the place, and its consequences. After the

initial assessment, each participant will receive a falls calendar to fill out over 22 weeks to

verify the effects of training (16 weeks) and short-term detraining (6 weeks). Once a month,

the participants will be reminded to fill out the calendar and asked about falls via telephone
contact or in person during training. Body mass index will be collected by dividing weight

(kg) by height squared.

Sample size

The sample size was calculated using the G*Power 3.1 statistical program based on

the primary outcome measures (global cognition and dual task performance). Assuming: 1)

the type of study design; 2) a type I error of 5%; 3) a statistical power of 80% (1-β = 0.80);

and 4) assuming a moderate to large magnitude effect size (0.4) [26], a minimum of 52

people is required to constitute the total sample.

Randomization

A randomization sequence will be created with Random Allocation software, with a

1:1 allocation using random block sizes, by an independent researcher with no involvement

in the trial. The allocation sequence will be concealed from the same independent

researcher enrolling participants in sequentially numbered, opaque, sealed, and stapled

envelopes. Envelopes with dark color will be used to render the envelope impermeable to

intense light. Corresponding envelopes will be opened by another independent researcher

only after the enrolled participants have complete all baseline assessments, for assessment

of primary outcomes and intervention, who will be responsible for advising participants of

their allocation by telephone.

Blinding

Participants and interventionists will be aware of the allocation because of the

characteristic of the protocol, but assessors will be blinded to group allocation.

Statistical methods

For statistical analysis, a significance level of 5% will be adopted and SPSS software

(18.0) will be used. The analysis will be performed by intention to treat. Therefore,
regardless of the frequency in the intervention program, all participants will remain in the

sample and program analysis.

The Kolmogorov-Smirnov normality test will be applied for all continuous variables

to verify data distribution. To compare groups regarding clinical and sociodemographic

characteristics, the Chi-square association test for categorical variables, the Independent t-

test for continuous variables with normal distribution, and the Mann-Whitney test for

continuous variables with non-normal distribution will be used.

To test the interaction between groups and assessments, Two-way ANOVA will be

used. If an interaction is identified, simple main effect analyses will be performed with

adjustment for multiple comparisons (Bonferroni). The Chi-square association test will be

used to verify differences in fall rates between groups at different times. To verify which

sociodemographic and clinical factors influence satisfactory adherence to hydrotherapy

(equal to or above 70% frequency), bivariate logistic regression analysis will be used. In

addition, power measures and sizes of the differences between groups in the pre and post

intervention moments (odds ratio, mean difference, confidence interval for the estimated

effect) will be calculated. The trial design is illustrated in Figure 2.

[Insert Figure 2 here]

Monitoring, ethics and dissemination

Regarding monitoring of the research, the same researchers will be responsible for

decision making in different cases, such as the need for changes in the evaluation and

intervention and the presence of adverse effects during the trial.

 Data collected in the assessments will be used only for scientific purposes with the

utmost confidentiality and these data will not be transferred to any person or entity outside

the protocol. Participants’ names will not be released. There will not be any personal

expenses or benefits to the participant, such as health or life insurance and financial

compensation. If there is any damage resulting from the research, compensation will be

guaranteed. The participant will have the right to leave the study at any time, if necessary,

without any prejudice to them. In addition, at all stages of the study, the participants will

have access to the researchers to clarify any doubts.

Results

We expect that the aquatic multicomponent exercise protocol associated with dual

tasks will reduce fall rates and improve some motor and neuropsychological risk factors

compared to the Control Group after training and short-term detraining.

This physical exercise alternative for geriatric populations has been reported to be

beneficial for improving balance, and motor and cognitive tasks, as well as providing high

motivation, adherence, and positive attitudes in community-dwelling adults [4,5,7,33]. This

type of exercise can serve as an effective training and rehabilitation protocol for reducing

falls in people aged 65 years and over.

Discussion

The main purpose of this trial is to verify the effects of hydrotherapy on falls

prevention and modifiable risk factors in community-dwelling people over 65 years.

According to the American College of Sports Medicine [6], physical exercise

protocols for people aged 65 years and over should include multicomponent training.

Furthermore, dual task exercises with cognitive tasks are important to improve motor and

cognitive function and prevent falls in this population [5,29]. As a form of falls prevention,
multicomponent training has been applied to reduce potentially modifiable risk factors for

falls [28]. Hydrotherapy has been used as a safer physical exercise alternative, which

causes less fear of falling while performing tasks, especially when participants present

balance deficits and postural changes [31].

A previous study verified greater effectiveness with aquatic physical exercise

compared to physical exercise on the ground to minimize risk factors and the occurrence of

falls [32]. Although previous protocols worked with modifiable risk factors for falls

[32,33], the sample of the present study will be people over 65 years without neurological

conditions related to a risk of falls, such as Parkinson’s.

A systematic review indicated that water exercises at moderate to high intensities

have positive effects on physical function in healthy people aged 65 years and over. No

differences between training sessions two and three times per week were found. However,

the authors reported the need for more high quality methodological research with aquatic

exercise protocols in different populations aged 65 years and over [4]. Furthermore, aquatic

protocols should have a minimum duration of 12 weeks to improve balance, strength, and

flexibility and prevent falls in people aged 65 years and over. The session duration should

be around 60 min and be performed two to three times per week [4].

The training protocol of this trial includes a short period of adaptation, which can

increase participants' confidence in the water and contribute to reduce the fear of falling.

Beyond benefits of physical exercise, the principles of water will be used. Progressions of

intensity will be individual and based on the Modified Borg Scale [6,14]. Despite being a

multicomponent protocol, the proposed exercises have easy applicability in small groups

and require few materials, such as balls, acquatubes, boards, shin guards, and cones.
 Aveiro et al. [32] verified higher adherence to an aquatic intervention (94.5%)

compared to an intervention on the ground (83.4%) in women aged 65 years and over with

osteoporosis. In the present trial, better adherence in the Hydrotherapy Group could lead to

lower risk factors and fall rates. In addition, the training will last 16 weeks and the effects

of detraining will be evaluated. Hydrotherapy warrants investigation as a falls prevention

strategy in people aged 65 years and over, based on the positive effects on some risk factors

for falls, and the interest and adherence of the population.

There are several modifiable risk factors for falls, such as reduced muscle strength,

mobility, balance, gait, cognitive function, fear of falling, and behavioral symptoms [33].

Impaired cognitive and behavioral factors can increase the risk of falls by reducing the

ability to make decisions, solve problems, and perform tasks simultaneously. Dual tasks

such as walking and answering a telephone require integration of sensorimotor and

cognitive systems. Slow cognitive processing speeds compromise motor planning and

balance in challenging environments [29]. The assessments chosen in this trial can be easily

applied and are useful to identify modifiable risk factors for falls and to plan future

interventions. As falls are multifactorial, this quantitative and evidence-based assessment of

potentially modifiable risk factors for falls will be valuable in explaining and supporting

recommendations for assessments and interventions in people aged 65 years and over.

Furthermore, the occurrence of falls will be collected over 22 weeks through a falls

calendar and monthly phone calls. The falls calendar is more accurate in detecting falls than

phone calls in developed countries [34]. In the present trial, the calendar is also expected to

show a higher fall rate compared to monthly phone calls. The participants will be instructed

to place the calendar in a visible place at home and will be reminded monthly to fill it in,

which could contribute to increased adherence to the tool.

 As this study is a clinical trial, it is important that the research group is prepared for

some limitations. Some problems that may arise during the study are pointed out here, as

well as their potential solutions: (i) problems of maintenance of the pool and heater in the

place where the intervention will be carried out: the research group will survey other

possible places with a pool, where activities could be developed without hindering the

progress of the work; (ii) recruitment difficulty: the group will increase its dissemination on

social networks; (iii) absence of a person responsible for speaking to interested people: the

group will recruit a person to be responsible for providing information to interested parties

and referring them to the researchers; (iv) absences associated with weather: the

participants will add more flexibility to the schedule.

Authors contributions:

Daniela Lemes Ferreira contributed to the study on Conceptualization, Data curation,

Formal analysis, Investigation, Methodology, Project administration, Resources,

Validation, Visualization, Roles/Writing – original draft and Writing – review & editing.

Dayane Melo Campos contributed to the study on Conceptualization, Data curation, Formal

analysis, Investigation, Methodology, Project administration, Resources, Validation,

Visualization, Roles/Writing – original draft and Writing – review & editing.

Verena Vassimon-Barroso contributed to the study on Conceptualization, Data curation,

Formal analysis, Investigation, Methodology, Validation, Visualization, Roles/Writing –

original draft and Writing – review & editing.

Jessica Cerutti contributed to the study on Conceptualization, Data curation, Investigation,

Methodology, Visualization, Roles/Writing – original draft and Writing – review & editing.
Ianne Sousa Souza contributed to the study on Conceptualization, Data curation,

Investigation, Methodology, Visualization, Roles/Writing – original draft and Writing –

review & editing.

Juliana Hotta Ansai contributed to the study on Conceptualization, Data curation, Formal

analysis, Funding acquisition, Investigation, Methodology, Project administration,

Resources, Software, Supervision, Validation, Visualization, Roles/Writing – original draft

and Writing – review & editing.

Financial support: CNPq and CAPES (code 001).

Declaration of Competing Interests: No potential conflicts of interest were disclosed.

Acknowledgements: The authors acknowledge the intellectual support given by CAPES

(001) and the financial support given by CNPq.

Data availability: The authors stated that any information can be obtained from the authors

on request.

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Figure 1. Flow chart of participants according to 2010 CONSORT recommendations
Figure 2. Trial design according to 2013 SPIRIT recommendations

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 Table 1. Intervention protocol of the Hydrotherapy Group
Training
Physical exercise Progression
component

Warm-up
Increased speed
(5 minutes)
Lateral
Anterior Walking Walking Trunk Lateral Flexion Trunk Rotation
(2 round trips) (2 round (1 set of 10 (1 set of 10
trips) repetitions) repetitions)

Resistance
and muscle
activation
focusing on
Intensity between 5-7
the main
Plantar Flexion- points on the Modified
muscle Flexion-Extension Abduction-Adduction
Extension Borg Effort Perception
groups of the (3 sets of 12 repetitions) (3 sets of 12 repetitions)
(3 sets of 12 repetitions) Scale: increased range
trunk and
of motion, movement
lower limbs
speed and additional
and
equipment (acquatubes,
associated
shin guards, balls)
cognitive
tasks
(20 minutes)

Squats Sit and stand

(3 sets of 12 repetitions) (3 sets of 12 repetitions)

Reduced sensory inputs

(vision and tactile) and
support base, increased
Balance
complexity of
(15 minutes)
movement and addition
of motor and cognitive
Semi-Static tasks
(3 sets of 30 seconds)
Overcoming and
Walking on a line
avoiding of obstacles
(3 round trips)
(3 round trips)
 Intensity between 5-7
points on the Modified
Borg Effort Perception
Aerobic
Scale: increased range
capacity
of motion, movement
(10 minutes)
speed and additional
Swimming equipment (acquatubes,
(5 minutes) shin guards)
Stationary Running
(5 minutes)

Cool-down
(stretching
associated
-
with deep
breathing)
(5 minutes) Lumbar Stretching
(30 seconds)
Lateral Trunk Stretching
(30 seconds) Lower Limb Stretching
(30 seconds)