Contemporary Clinical Trials 40 (2015) 2634

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Contemporary Clinical Trials

journal homepage: www.elsevier.com/locate/conclintrial

Challenges in conducting a randomized clinical trial of older

people with chronic dizziness: Before, during and after
vestibular rehabilitation
Natalia A. Ricci a,b,, Mayra C. Aratani a, Helosa H. Caovilla a, Fernando F. Ganana a
a
b

Department of Otorhinolaryngology and Head & Neck Surgery, Division of Otoneurology, Federal University of So Paulo (UNIFESP), So Paulo, Brazil
Masters and Doctoral Programs in Physical Therapy, City University of So Paulo (UNICID), So Paulo, Brazil

a r t i c l e

i n f o

Article history:
Received 18 September 2014
Received in revised form 31 October 2014
Accepted 1 November 2014
Available online 8 November 2014
Keywords:
Patient dropouts
Patient adherence
Dizziness
Vestibular rehabilitation
Elderly

a b s t r a c t
Purpose: This study aims to describe the process of conducting a randomized clinical trial of
elderly with chronic dizziness subjected to vestibular rehabilitation (VR) and to verify its
effectiveness on dizziness intensity.
Methods: Older adults (65 years) with chronic dizziness from vestibular disorders referred to VR
were enrolled to the trial. The control group (n = 40) was submitted to the Cawthorne & Cooksey
protocol and the experimental group (n = 42) to the modified Cawthorne & Cooksey protocol which
included multiple components. Protocols were performed during individual 50-minute sessions,
twice-weekly, for eight weeks. Main measures were: recruitment data (refusal and eligibility),
baseline characteristics, dropout rate, session attendance, protocol adherence, adverse effects,
exercise adaptation and follow-up events. The Visual Analog Scale (VAS) was used to measure
dizziness intensity.
Results: 144 elderly were referred to VR, 26.4% declined to participate and 16.7% were ineligible.
There were 51 session non-attendances, with disease being the most frequent reason. Regardless of
VR protocol, VAS dizziness intensity diminished along sessions (p b 0.001). 88.6% of the participants
reported improvement after treatment, and 22.9% mentioned an increase in dizziness on follow-up.
Home exercises were no longer being performed by 21.4% of the subjects after 3 months from
discharge. The final dropout rate was 14.6%. There were no differences between VR protocols on
recruitment, dropout, session's attendance, adherence to protocol and treatment effects.
Conclusions: Our results revealed many challenges in conducting a rehabilitation trial with an elderly
sample. The VR protocols showed to be feasible and suitable to reduce dizziness in older adults.
2014 Elsevier Inc. All rights reserved.

1. Introduction
Clinical trials with focus on older adults are of increasing
importance [1], especially considering the growth of elderly
population and the need for evidences to improve their care.

Abbreviations: BPPV, Benign paroxystic positional vertigo; CCC, Cawthorne

& Cooksey Conventional; MCC, Multimodal Cawthorne & Cooksey; MMSE, Mini
Mental State Exam; VAS, Visual Analog Scale; VR, Vestibular rehabilitation.
Corresponding author at: Rua Afonso Celso, 982 ap12, Vila Mariana, 04119060, So Paulo, SP, Brazil. Tel.: +55 11 25286484.
E-mail address: natalia_ricci@hotmail.com (N.A. Ricci).

Conducting a clinical trial involves protocol design, recruitment, protocol implementation, retention, analysis and dissemination of results [2]. Unfortunately, much attention is
carried on the trial protocol design and results, i.e., the effect of
an intervention on outcomes; while the other research stages
are underrepresented on reports. This is a gap for evidencebased practice.
There are many inherent challenges in conducting clinical
trials with samples composed by older adults [3,4]. Ineligibility,
due to the presence of comorbidities, disability and disease
status, seems to be the greatest barrier to clinical trial enrollment
among older adults [1]. Declining to participate is another

http://dx.doi.org/10.1016/j.cct.2014.11.002
1551-7144/ 2014 Elsevier Inc. All rights reserved.

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obstacle in rehabilitation trial recruitment, and its major reasons

refer to transportation difficulties (lack of money or distance), no
accompany (caregiver or partner) to go to the intervention site,
lack of interest and dislike of exercise [5]. Once under treatment,
there are also hindrances related to the research protocol
adherence, including numerous and time-consuming appointments and lack of accessibility [6]. In addition, the elderly
population is more likely to have comorbidities that can lead to
unstable conditions and to develop other illnesses resulting in
non-attendance to the sessions, exclusion or dropout from the
study protocol [3].
Vestibular rehabilitation (VR) is recommended for treating
the symptoms of vestibular impairment [7]. Clinical trial results
show that VR is beneficial for older adults in outcomes such as
gait [8], body balance control [9] and activities of daily living
[10,11]. However, none out of nine randomized clinical trials
about VR in middle-age and older adults did report the
challenges in conducting the study or adverse effects related
to intervention [12]. The authors from a systematic review
regarding the effects of VR in unilateral peripheral vestibular
dysfunction concluded that further investigation of patient
compliance and adverse events are needed in this field [13].
Process evaluation of rehabilitation trials is understudied,
particularly in older people with dizziness. And as well as, in
research, physical therapists also treat patients with comorbidities and cope with their non-attendance or non-adherence
on clinical practice. Thus, detailed description of the recruitment, attendance at therapy sessions, and adherence to the
research protocol can assist with interpretation of the generalizability of the study findings [2], and so help practitioners to
improve older patient care. Therefore, the purpose of this
report is to describe the process of conducting a VR clinical trial
(recruitment, attendance at therapy sessions, effects during
therapy, adherence to the research protocol/home exercises
and events on follow-up) for older people with chronic
dizziness.
2. Material and methods
This is a process evaluation of a randomized controlled trial
with a 3 month follow-up designed to verify the effectiveness

27

of VR on older people with chronic dizziness. The study was

approved by the Federal University of So Paulo Ethics Review
Board (1656/09) and was registered in the Australian New
Zealand Clinical Trials Registry (ACTRN 12610000018011). The
protocol of this randomized trial was published previously [14].
A detailed timeline diagram of the variables assessed during
the recruitment, intervention and follow-up periods is presented in Fig. 1.
2.1. Recruitment period
The study was conducted at a public Otoneurology outpatient
clinic (So Paulo, Brazil). The estimated sample size calculation
indicated 68 patients, with at least 15% more individuals to
compose the final sample and minimize dropouts [14]. The
sample size was designed to have sufficient power to compare
VR groups regarding primary outcomes (balance control and
functional capacity) for the randomized clinical study. Those
patients from the outpatient clinic who required VR had their
names, age, sex and contact information included in a general
waiting list. The patients received a telephone call describing the
purposes of the study and the VR treatment. For those who
refused to take part in the study their reasons to decline were
registered. For those interested in participating, an appointment
was scheduled at the outpatient clinic to confirm their eligibility.
Inclusion criteria were: 65 years old and over, both sexes,
and clinical diagnosis of chronic dizziness resulting from a
vestibular disorder, i.e., failure to compensate dizziness two
months or more after the first occurrence [15]. Individuals were
excluded in cases of dizziness not resulting from a vestibular
disorder, cognitive deficit (reference values according to the
Mini-Mental State Examination MMSE [16]), locomotion
requiring a walker or a wheelchair, practicing regular physical
activities [17], those submitted to VR in the previous 6 months,
under medication for vestibular disorders, and those presenting benign paroxystic positional vertigo (BPPV). If the person
was ineligible to the trial, the reason for exclusion was
recorded.
Those excluded by the telephone contact and ineligible
were referred for rehabilitation outside the research protocol.
All eligible participants gave their informed consent and were

Fig. 1. Trial timeline diagram with the variables assessed during the recruitment, intervention and follow-up periods.

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N.A. Ricci et al. / Contemporary Clinical Trials 40 (2015) 2634

then submitted to the baseline evaluation. At baseline the

following data were collected to characterize the sample:
socio-demographic data, health status and vestibular dysfunction characteristics. These data were compared between VR
protocols.
2.2. Intervention period
After the baseline assessment, the older individuals were
randomly assigned to a control group (Conventional VR) or an
experimental group (Multimodal VR). Randomization was
accomplished by a statistical computer program, by blocks.
Nine blocks (4 to 12 participants) were formed, of which six
were composed of an odd number of participants. As a
consequence the VR groups have a different sample size. The
study was categorized as single blind, since only the outcome
assessor was unaware of intervention assignment. However,
the patients were blinded in relation to the protocol they were
involved in.
The conventional Cawthorne & Cooksey protocol consists of
eye, head and trunk exercises [18,19]. The modified multimodal Cawthorne & Cooksey protocol involves, in addition to the
conventional, flexibility, cognition, sensory interaction, and
muscle strength components. Both VR protocols comprise four
stages concerning the body position adopted during the
exercises (1 lying down, 2 sitting, 3 standing, and 4
walking). The VR started with the lying down and sitting stages
(one week each); followed by the standing and walking stages
(three weeks each). Before the outset of both protocols, the
subjects received a booklet including general information about
VR, dietary counseling, fall prevention and home exercises.
Home exercises should be daily performed for 28 min and
consisted of head/eye movements while lying down and sitting.
The VR protocols were applied in individual 50 minute sessions,
twice a week, for two months (total: 16 sessions). Details about
the VR protocols are published elsewhere [14].
Under the condition of non-attendance, the session was
rescheduled to be performed in the same week. In the event of
three (random or consecutive) absences during treatment, the
subject was excluded from the research and regarded as a
withdrawal. During the intervention period, the causes of nonattendance, as well as the reasons claimed for dropouts, were
collected.
At each session, the absences, adherence to the protocol
(reasons for not completing the full-time training), adverse
events, difficulty in performing the exercises, past 24 hour
dizziness intensity according to the Visual Analog Scale
graduated numbered (VAS), and home exercise adherence
(per week) were recorded. Data were compared between VR
groups.
2.3. Follow-up period
The follow-up assessment took place three months after the
VR disclosure, and included the evaluation of dizziness symptoms, hospitalization, unexpected clinical appointments, change
in medication, use of medication for dizziness, new clinical
diagnosis, and occurrence of negative events in life.
During the follow-up period the participants were instructed
to continue performing daily home exercises described in the
booklet. The home exercise adherence was assessed by the

reports of frequency (days per week) and duration (minutes

each time) the exercises were performed.
In order to evaluate the success of blinding, at the end of the
follow-up assessment the outcome assessor wrote on the subject
chart which treatment protocol she thought the participant was
allocated to, and the subjects were asked to provide their
opinion concerning which type of VR they had received. The data
from the assessor and patients were later compared with the
randomization codes.
Those participants who failed to show up to the follow-up
assessment received a phone call and the reason for the
absence was recorded.
2.4. Statistical analysis
Qualitative data were based on the reports of the trial stages.
Quantitative data are presented descriptively by absolute
numbers, percentages, means and standard deviations. The
comparison of VR groups was undertaken using the Mann
Whitney U-test for continuous measures and the Chi-squared
test or Fisher's exact test for categorical variables.
To compare the VAS between the VR protocols, a sample of
34 individuals per group was required to detect a difference of
1.5 point for dizziness intensity with an estimated standard
deviation of 2.5. For the sample size calculation it was
considered data of previous studies [9,20]; and a statistical
power of 80% and a significance level of 5% (). Analysis of
variance with repeated measures was used to evaluate the
dizziness intensity progression by the VAS during the 16
sessions (repeated factor) and the VR protocols (fixed factor).
The difference between VAS session 1 and VAS session 16
within group was performed by using the Wilcoxon test and
among groups by using the MannWhitney U-test. For these
analyses we conducted an intention to treat strategy using the
last observation carried forward.
The statistical analysis was performed using the SPSS
version 13.0 (SPSS Inc., Chicago, IL, USA) with a significance
level of = 0.05.
3. Results
3.1. Recruitment period
During the recruitment period (March 2010 to February
2012) a total of 144 elderly subjects were in the waiting list for
VR treatment. From these, 38 (26.4%) were excluded at the
telephone contact and 24 (16.7%) did not meet the inclusion
criteria. The subjects excluded at the telephone contact had
74.6 6.3 years, and were mostly women (86.8%, n = 33). The
reasons for declining to participate in the trial were: death
(n = 1), severe disability (n = 3), lack of transport to the
clinical setting (n = 10), no more complaint about dizziness
(n = 11), and not interested in performing exercises as a
treatment (n = 13). Those considered not eligible had 72.7
4.9 years, and 66.7% (n = 16) were women. The reasons for
ineligibility were: dizziness not resulting from a vestibular
disorder (n = 2), cognitive deficit by the MMSE (n = 2),
locomotion with a walker or a wheelchair (n = 2), diagnosis of
BPPV (n = 4), other severe health problem (n = 5), and regular
physical activities (n = 9). The final sample was composed of
82 older people with mean age of 74.3 6.4 years (65 to

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29

Table 1
Socio-demographic and health characteristics of the elderly participants according to the vestibular rehabilitation protocol.
Characteristic

n (%)
mean SD

Age (years)
Sex

Female
Male
Illiterate
Elementary
High School
University

Level of education

Number of diseases
Diabetes mellitus
Hypertension
Stroke
Visual impairment
Rheumatism
Number of medications
Musculoskeletal pain
Smoking habit

Yes
Yes
Yes
Yes
Yes
Yes
Never smoked
Ex-smokers
Smokers

MMSE

p-Value

Conventional
(n = 40)

Multimodal
(n = 42)

74.18 5.98
27 (67.5%)
13 (32.5%)
5 (12.5%)
29 (72.5%)
2 (5.0%)
4 (10.0%)
5.50 1.89
10 (25.0%)
31 (77.5%)
7 (17.5%)
26 (65.0%)
22 (55.0%)
5.65 3.53
30 (75.0%)
23 (57.5%)
15 (37.5%)
2 (5.0%)
24.50 3.13

74.43 6.87
32 (76.2%)
10 (23.8%)
1 (2.4%)
37 (88.1%)
1 (2.4%)
3 (7.1%)
5.43 2.17
12 (28.6%)
35 (83.3%)
5 (11.9%)
22 (52.4%)
28 (66.7%)
5.93 3.11
34 (81.0%)
28 (66.7%)
12 (28.6%)
2 (4.7%)
25.64 2.83

0.944a
0.381b
0.254c

0.800a
0.715b
0.505b
0.474c
0.246b
0.279b
0.644a
0.515b
0.679c

0.109a

MMSE = Mini Mental State Exam.

a
MannWhitney.
b
Chi-square.
c
Fisher test.

90 years old) and mostly women (72.0%). There were no

differences in gender (Chi-squared, p = 0.126) and age
(MannWhitney, p = 0.480) between those excluded by
telephone contact, not eligible and the final sample. Thus, the
recruitment rate was 56.9% (82/ 144) of the total sample
referred for VR.
The sample was randomized into the Conventional (n =
40) and Multimodal (n = 42) VR protocols. The sociodemographic data and health status were similar between VR
groups at baseline (Table 1).
Half of the participants presented peripheral vestibular
disorder, and the majority complained of non-rotational dizziness (58.5%) with long-term onset of symptoms (5 years =
53.6%). The most common symptoms linked to the vestibular
dysfunction were tinnitus (73.1%) and hearing loss (56.0%). The
vestibular dysfunction characteristics were similar between VR
groups at baseline (Table 2).

3.2. Intervention period

There were 9 (10.9%) dropouts during the intervention
period, with 6 being from Multimodal (5 women and 1 man)
and 3 being from Conventional (2 women and 1 man). In the
Conventional group the dropouts occurred during the VR final
stages (standing = 1 and walking = 2); and in the Multimodal
group dropouts took place along all the intervention period
(lying down = 2, sitting = 2, standing = 1, walking = 1).
The causes for dropout were: didn't want to continue the
VR treatment (Multimodal = 3), decompensated disease
(Conventional = 1; Multimodal = 1), unjustified absences
(Conventional = 1; Multimodal = 2), difficulty in transportation (Multimodal = 1), and spouse's illness (Conventional =
1).

The number of missed sessions was 51, with 8 being from

the dropouts (Conventional = 2; Multimodal = 6) and 43 being
from the ones who completed the intervention period (Conventional = 25; Multimodal = 18). There was no difference
between the intervention groups regarding the number of
absences (MannWhitney, p = 0.641). The most common
cause for participants' non-attendance was disease (Table 3).
Treatment protocols were well tolerated by both groups.
Concerning the adherence to the protocol, one elderly in the
Conventional group did not complete the full time training due
to severe nausea followed by vomiting in the lying down stage;
and two seniors, one from each group, failed to complete a
session of the standing stage due to arterial hypotension. Along
the sessions adverse effects occurred with no need of exercise
interruption, which were dizziness, imbalance, musculoskeletal pain, fatigue, nausea, oscillopsia and tinnitus. Regardless of
the group, no fall occurred during the VR sessions.
Some patients had difficulty in performing the exercises
exactly as they were described in the VR protocol. These
exercises were adapted to the patient's ability and they are
listed in Table 4. There was no case of deviation from the
original VR protocols.
The dizziness intensity, measured by the VAS, significantly
diminished along the sessions (p b 0.001), but there was no
interaction, i.e., sessions versus groups (p = 0.551). Being
compared with the initial VAS, a significant decrease was first
observed in the fourth session evaluation (p = 0.024). A
plateau occurred after the 15th session (p = 0.921) related to
the final VAS. Both groups have significantly decreased
dizziness intensity, comparing the initial and the final VAS
(Conventional = 2.20 2.63, Wilcoxon, p b 0.001; Multimodal = 2.29 3.06, Wilcoxon, p b 0.001), with no difference
between them (MannWhitney, p = 0.787). The VAS progress
by session is presented in Fig. 2.

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N.A. Ricci et al. / Contemporary Clinical Trials 40 (2015) 2634

Table 2
Vestibular dysfunction characteristics and related symptoms of the elderly participants according to the vestibular rehabilitation protocol.
Characteristic

n (%)

Topographic vestibular diagnosis

Peripheral
Central
Mixed
Rotational
Non-rotational
Mixed
311 months
12 years
34 years
5 years
Days
Hours
Minutes
Seconds
Sporadic
Monthly
Weekly
Daily
Yes
Yes
Yes
Yes
Yes
Yes

Dizziness description

Onset of symptoms

Duration of symptoms

Frequency

Tinnitus
Nausea/vomiting
Sweating/tachycardia
Aural fullness
Oscillopsia
Hearing loss
a
b

p-Value

Conventional
(n = 40)

Multimodal
(n = 42)

19 (47.5%)
6 (15.0%)
15 (37.5%)
2 (5.0%)
22 (55.0%)
16 (40.0%)
2 (5.0%)
7 (17.5%)
6 (15.0%)
25 (62.5%)
9 (22.5%)
3 (7.5%)
9 (22.5%)
19 (47.5%)
9 (22.5%)
4 (10.0%)
9 (22.5%)
18 (45.0%)
28 (70.0%)
21 (52.5%)
12 (30.0%)
18 (45.0%)
21 (52.5%)
22 (55.0%)

22 (52.4%)
5 (11.9%)
15 (35.7%)
2 (4.8%)
26 (61.9%)
14 (33.3%)
4 (9.5%)
11 (26.3%)
8 (19.0%)
19 (45.2%)
12 (28.6%)
3 (7.1%)
15 (35.7%)
12 (28.6%)
8 (19.0%)
2 (4.8%)
13 (31.0%)
19 (45.2%)
32 (76.2%)
19 (45.2%)
10 (23.8%)
18 (42.9%)
21 (50.0%)
24 (57.1%)

0.877a

0.811b

0.455b

0.326b

0.698b

0.527a
0.511a
0.527a
0.845a
0.821a
0.845a

Chi-square.
Fisher test.

The Conventional group self-report of non-adherence to the

home exercises was 2.45 2.61 weeks and the Multimodal
group was 2.52 2.57 weeks (MannWhitney, p = 0.898).
During treatment three patients from the Conventional group
phone contacted the therapist regarding severe dizziness (n =
2) and tinnitus (n = 1). One patient from the Conventional
group has used medication to control vestibular symptoms for
one week, and another one from the Multimodal group
reported to have used it for one day only.

3.3. Follow-up period

Three subjects missed the follow-up evaluation. The causes
for missing were: trip to another city (Multimodal = 1), illness
(Multimodal = 1) and didn't want to participate (Conventional = 1).

Throughout the 3 month follow-up period 40.0% of the

subjects had their medication prescription changed, 30.0%
suffered a personal negative event in life, and 28.5% required a
medical appointment out of routine. There were no differences
between VR groups in relation to the follow-up variables
(Table 5).
Among those evaluated at follow-up (n = 70), 21.4%
(Conventional = 8 and Multimodal = 7) reported not to be
performing the home exercises. Those who continued the
home exercise were performing it, on average, 4 times a week
(Conventional = 3.72 days; Multimodal = 4.12 days) for more
than 20 min (81.8%; Conventional = 20 and Multimodal = 25).
There was no difference regarding the home exercise reports
between VR protocols (MannWhitney, p = 0.486).
The majority of the participants (88.6%; n = 62; Conventional = 33 and Multimodal = 29) stated a decrease in
dizziness symptom with the VR treatment; 11.4% (n = 8;

Table 3
Participants' reasons for non-attendance in vestibular rehabilitation sessions.
Reason for non-attendance

Disease (i.e., inuenza)

Travel
Transportation
Forgetfulness
Need to help other
No accompany to go to session
Death of family member
Hospitalization
Medical appointment

Total

20
6
6
5
5
3
2
2
2

Dropouts

Completers

Conventional

Multimodal

Conventional

Multimodal

8
5
4
1
2

1
2
2

10
1
2
1
3

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31

Table 4
Number of participants that required exercise adaptation according to the vestibular rehabilitation protocol.
Exercise

Stage

Total

Conventional

Multimodal

Bending forward and picking up an object from the ground

Shoulder shrugging and circling

Sitting
Sitting
Standing
Standing
Standing
Standing
Moving
Moving

4
4

2
1

2
3

1
1
8
2
1

1
4
2
1

Sitting to standing position lower seat heighta

Throwing a ball from hand to hand above eye level
Throwing a ball from hand to hand under knees lifting foot
Walking across the room with eyes closed
Throwing a ball towards targets attached to a wall
a

Lower sit used only in the multimodal protocol.

Conventional = 3 and Multimodal = 5) referred no change,

and none of the subjects mentioned an increase in symptom.
The VR groups showed no difference regarding the dizziness
perception in the end of treatment (Fisher, p = 0.402). In the
follow-up period, 47.1% of the participants (n = 33; Conventional = 17 and Multimodal = 16) stated that the dizziness
decreased even more, 30% (n = 21; Conventional = 13 and
Multimodal = 8) referred no change, and 22.9% (n = 16;
Conventional = 6 and Multimodal = 10) mentioned an
increase in relation to the symptom observed at the end of
the intervention. The VR groups showed no differences
regarding the dizziness perception in the follow-up assessment
(Fisher, p = 0.339).
During follow-up, one patient from the Conventional group
and another one from the Multimodal group phone contacted
the therapist regarding severe imbalance and sudden hearing
loss, respectively.
The final dropout rate was 14.6% (n = 12), with no difference
regarding VR protocols (Conventional = 4 versus Multimodal =
8; Fisher test, p = 0.351). There were no differences in gender
(Fisher, p = 0.799), age (MannWhitney, p = 0.921), topographic vestibular diagnosis (Fisher, p = 0.930) and VAS first
session (MannWhitney, p = 0.491) between those considered
as dropouts (n = 12) and those who completed all the protocol
phases (n = 70).
The outcome assessor guessed the correct allocation of VR
protocol in 54.2% (n = 38) of the cases and the patients did it
on 50% (n = 35).

4. Discussion
Unlike many other studies in rehabilitation field, this study
revealed that the process of conducting a VR trial with elderly
people faces several challenges. These challenges might also
arise in the physiotherapist daily practice. Thus, trial reports
with more detailed description, which goes beyond the outcome
results, should approximate research to clinical practice.
In Geriatric and Gerontology research, the subjects (older
adults) are often affected by comorbidities in addition to the
predominant disease under investigation. However, clinical
research has historically shown the tendency to maximize
internal validity by applying excessively restricted sample
selection criteria, thereby excluding subjects with comorbidities [21,22]. Their exclusion results in recruitment difficulty
and, which is even worse, lack of fit between clinical trial
participants and real healthcare users [23]. Hence, clinical trial
reports should allow practitioners to judge to whom the
intervention can reasonably be applied [24]. Our report has
provided an overview of its sample characteristics, which are
very similar to those observed by epidemiological studies with
elderly complaining of dizziness andor imbalance [2528].
This shows that our study has satisfactory external validity, and
therefore will help physiotherapist in delivering VR more safely
to their own elderly patients. One of the most noteworthy
characteristic found in our sample is the chronicity of dizziness.
This is a long-lasting problem among elderly [25,26,28],
emphasizing the need for early effective treatment, such as

Fig. 2. Comparison between vestibular rehabilitation protocols regarding the Visual Analog Scale for dizziness intensity along the intervention period (16 sessions).

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N.A. Ricci et al. / Contemporary Clinical Trials 40 (2015) 2634

Table 5
Events during follow-up period according to the vestibular rehabilitation protocol.
Variable

n (%)

Hospitalization
Medical appointment out of routine
Medication change
New diagnosis
Personal negative event
a
b

Yes
Yes
Yes
Yes
Yes

p-Value

Conventional
n = 36

Multimodal
n = 34

1 (2.8%)
8 (22.2%)
14 (38.9%)
3 (8.3%)
12 (33.3%)

4 (11.8%)
12 (35.3%)
14 (41.2%)
2 (5.9%)
9 (26.5%)

0.145a
0.226b
0.845b
0.691a
0.531b

Fisher test.
Chi-square.

VR, to prevent the cascade of negative events associated with

prolonged exposure to dizziness.
Regarding recruitment, most studies require approximately
three older adults to be screened for every subject included in
the trial [23]. Our recruitment rate was more influenced by
refusal to participate (26.3%) than by ineligibility (16.6%). As
described in our study, lack of transport to the clinical setting is
often reported as a problem in rehabilitation trials [5,29].
It might be inferred that inability to continue driving and
mobility difficulties might prevent elderly from accessing
health care settings as frequently as recommended [23].
Bearing this in mind, researchers and clinicians should provide
alternatives for their patients to easily reach the therapeutic
settings, such as special vehicles for disabled people, not
scheduling sessions during peak traffic hours, and considering
home care service.
Dropout rates and the difference between completers and
dropout subjects are factors that can compromise the outcome
of a clinical trial [2,30]. Fortunately in the present trial the total
dropout rate of 14% was within the expected. This result is
similar to most clinical trials with dizzy patients, which show,
low to moderate dropout rates [12,13]. Besides, we did not find
differences between completers and dropouts, which assures
more reliable results of the effects of the intervention tested in
this trial.
Non-attendance to therapy sessions is a matter of concern for
either researchers or clinicians. For researchers this can imply in
participant withdrawal from the trial; and for practitioners the
absence can delay the rehabilitation process. Even though we
have tried to prevent absences by providing a passbook with
session appointments and flexible session schedule and by
facilitating reschedules, we still had three withdrawals caused
by non-attendance, and completers missed an average of 1.7
sessions. These absences were mostly related to health problems
which could not be anticipated and evidence the inherent
transitory feature of elderly's health status.
Concerning the intervention effects, we used the VAS to
evaluate it. A trial with an elderly sample revealed a significant
reduction on vertigo intensity by the VAS for a multimodal
exercise group in comparison with a non-intervention group.
[9]. In a randomized trial comparing the effectiveness of two VR
protocols (Cawthorne & Cooksey protocol versus vestibuloocular reflex exercises) after 60 days of intervention, both
groups decreased VAS dizziness with no difference between
them [10]. Likewise, in our study both VR protocols diminished
significantly the intensity of dizziness by the VAS with no
difference between them. These results reinforce the use of
protocols with exercises based on the principles of VR, i.e.,

adaptation, habituation and substitution; given its effectiveness

in diminishing the dizziness symptom.
Until this moment, no trial has ever evaluated the dizziness
complaint along the treatment course. Commonly, physiotherapists advise their patients undergoing VR that some exercises
may, at first, make symptoms seem worse. But with time and
consistent work, symptoms will steadily improve [31]. According to our study, it seems that the dizziness symptoms did not
increase, but remained the same for almost 10 days, or for at
least 3 sessions. This information, if communicated to the
patients, might be a strong reinforcement to prevent them from
giving up on exercises, since results might certainly show up in
due time.
Generally, VR intervention is delivered once or twice a week
for 6 to 8 weeks for patients with peripheral vestibular disorders
[32]. For those with central or mixed vestibular disorders, a
longer time is generally required to achieve clinically meaningful
changes [32]. We observed a plateau in the VAS dizziness
intensity in the penultimate session, which indicates that an
8 week program might be considered sufficient for elderly.
Nevertheless, we did not analyze these results according to
topographic vestibular diagnosis and if such effect was influenced by home exercises.
The exercises proposed by the VR protocols were well
accepted by the elderly. Even so, some adverse effects (nausea,
imbalance, neck pain) occurred while patients performed the
exercises. Since most of these adverse effects are expected in
people with vestibular disorders [33], the physiotherapist
should warn patients that these effects can happen, but are
still manageable. Just a few VR exercises needed adaptation and
even with all the changes proposed by the experimental
protocol, nearly no difference occurred between protocols.
The exercise which required the greatest extent of adaptation
in both groups was the throwing a ball from hand to hand
under knees lifting foot exercise. It was expected, since this
exercise simulates single leg stance which is one of the most
challenging posture for elderly to maintain balance [34].
Regarding adherence, just three patients could not complete one of the VR sessions. However, these episodes did not
interfere in the continuity of treatment. One of the strategies to
help ensure high adherence to the protocol is the agreement
between patients and therapist upon the tolerance level of the
adverse symptom during the exercise [33]. Another strategy
might be the encouragement from researchers/therapists to
participants during sessions [5].
After VR 88.6% of the patients reported improvements in
symptoms. However, the benefits were not sustained throughout the follow-up period in 22.9% of the patients. Considering

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N.A. Ricci et al. / Contemporary Clinical Trials 40 (2015) 2634

the elderly physiological perspective, it is unlikely that the

improvement gained after an exercise program will be present
long after its interruption [35]. Other factors, such as the ones
that occurred in the follow-up period might also influence the
sustainability of rehabilitation results.
In an attempt to maintain the VR results, a home exercise
program was delivered after rehabilitation completion. Even
though the patients were used to these exercises, at least 21.4%
of the elderly who completed the follow-up evaluation were
not performing it anymore. It is common that patients stop
adhering to home exercise program when the symptoms
decrease or disappear [36]. Besides, change in health status was
the primary reason for poor adherence to home exercises
following physiotherapy intervention in elderly with impaired
balance [37]. In clinical practice, poor adherence to home
exercises can lead in long term to new admission for rehabilitation, increasing health costs and disability risks. Improving
home exercise adherence after discharge from rehabilitation can
be achieved with regular phone-call reminders, systematic
follow-up appointments to tailor exercise level and education
(reinforce the importance of exercise).
An appropriate physical environment in which the trial is
conducted, a personalized treatment, social interaction, staff
empathy and support, and flexibility in scheduling (assessment
and therapies) are elements that help to promote research
protocol accomplishment [3,23,30]. In this trial, the aforementioned elements, added to the welcoming atmosphere, the
individualized supervision and provision of direct-anytime
telephone contact with the researchers may have contributed
to the high compliance of the elderly to the research protocol.
Therefore, in order to succeed in all the research stages and
produce reliable results the trial design must be adapted to the
needs of this exclusive population, that is elderly [1].
Nevertheless, it is important to point out that the results of
this study concerns to elderly patients referred for VR by
physicians, in a public Otoneurology outpatient clinic, treated
by physiotherapists specialized in Gerontology at individualized sessions. These characteristics may be related to our
findings and should be kept in mind whenever our protocol is
intended to be implemented in other therapeutic scenarios.
Furthermore, as we did not have a control group without
intervention, we cannot totally exclude the possibility that a
natural recovery might have influenced our results, although it
is considered very unlikely in chronic conditions.
Despite the expansion of rehabilitation trials with elderly,
few papers have systematically described their process and
challenges. The results of this study can inform other
researchers how to improve trial design and reports in the
field of rehabilitation. This manuscript also favors evidencebased practice for physical therapist practitioners. The VR
protocols showed to be feasible, adequate, safe and effective to
reduce intensity of the dizziness symptom in older adults.
Acknowledgments
The study was supported by So Paulo Research Foundation
(FAPESP, So Paulo, Brazil) reference number 2009/16908-6.
Funding from FAPESP provided a PhD scholarship (NA RICCI)
and materials to execute the VR protocols. We thank the staff
and patients from the UNIFESP Otoneurology outpatient clinic
for their contribution on this project.

33

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