Contemporary Clinical Trials: Natalia A. Ricci, Mayra C. Aratani, Heloísa H. Caovilla, Fernando F. Ganança
Contemporary Clinical Trials: Natalia A. Ricci, Mayra C. Aratani, Heloísa H. Caovilla, Fernando F. Ganança
Contemporary Clinical Trials: Natalia A. Ricci, Mayra C. Aratani, Heloísa H. Caovilla, Fernando F. Ganança
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.
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
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Fig. 1. Trial timeline diagram with the variables assessed during the recruitment, intervention and follow-up periods.
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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
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Table 2
Vestibular dysfunction characteristics and related symptoms of the elderly participants according to the vestibular rehabilitation protocol.
Characteristic
n (%)
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.
Table 3
Participants' reasons for non-attendance in vestibular rehabilitation sessions.
Reason for non-attendance
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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Table 4
Number of participants that required exercise adaptation according to the vestibular rehabilitation protocol.
Exercise
Stage
Total
Conventional
Multimodal
Sitting
Sitting
Standing
Standing
Standing
Standing
Moving
Moving
4
4
2
1
2
3
1
1
8
2
1
1
4
2
1
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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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.
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References
[1] Denson AC, Mahipal A. Participation of the elderly population in clinical
trials: barriers and solutions. Cancer Control 2014;21(3):20914.
[2] Carroll CB, Zajicek JP. Designing clinical trials in older people. Maturitas
2011;68:33741.
[3] Cassidy EL, Baird E, Sheikh JI. Recruitment and retention of elderly patients
in clinical trials: issues and strategies. Am J Geriatr Psychiatry 2001;9:
13640.
[4] Forster SE, Jones L, Saxton JM, Flower DJ, Foulds G, Powers HJ, et al.
Recruiting older people to a randomised controlled dietary intervention
trial how hard can it be? BMC Med Res Methodol 2010;10:17.
[5] Scianni A, Teixeira-Salmela LF, Ada L. Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in
Brazil: a feasibility study. Braz J Phys Ther 2012;16(1):405.
[6] Schlenk EA, Ross D, Stilley CS, Dunbar-Jacob J, Olshansky E. Research
participation among older adults with mobility limitation. Clin Nurs Res
2009;18(4):34869.
[7] Cohen H. Vestibular rehabilitation improves daily life function. Am J Occup
Ther 1994;48(10):91925.
[8] Johansson M, kerlund D, Larsen HC, Andersson G. Randomized controlled
trial of vestibular rehabilitation combined with cognitivebehavioral
therapy for dizziness in older people. Otolaryngol Head Neck Surg 2001;
125(3):1516.
[9] Kammerlind AS, Hkansson JK, Skogsberg M. Effects of balance training in
elderly people with nonperipheral vertigo and unsteadiness. Clin Rehabil
2001;15(5):46370.
[10] Simoceli L, Bittar RSM, Sznifer J. Adaptation exercises of vestibulo-ocular
reflex on balance in the elderly. Intl Arch Otorhinolaryngol 2008;12(2):
1838.
[11] Resende CR, Taguchi CK, Almeida JG, Fujita RR. Vestibular rehabilitation in
elderly patients with benign paroxysmal positional vertigo. Rev Bras
Otorrinolaringol 2003;69(4):348.
[12] Ricci NA, Aratani MC, Don F, Macedo C, Caovilla HH, Ganana FF. A
systematic review about the effects of the vestibular rehabilitation in
middle-age and older adults. Rev Bras Fisioter 2010;14(5):36171.
[13] Hillier SL, Holohan V. Vestibular rehabilitation for unilateral peripheral
vestibular dysfunction. Cochrane Database Syst Rev 2011(2):CD005397.
[14] Ricci NA, Aratani MC, Caovilla HH, Ganana FF. Effects of conventional
versus multimodal vestibular rehabilitation on functional capacity and
balance control in older people with chronic dizziness from vestibular
disorders: design of a randomized clinical trial. Trials 2012;13:246.
[15] Cohen HS, Kimball KT. Decreased ataxia and improved balance after
vestibular rehabilitation. Otolaryngol Head Neck Surg 2004;130:
41825.
[16] Bertolucci PH, Brucki SM, Campacci SR, Juliano Y. The Mini-Mental State
Examination in a general population: impact of educational status. Arq
Neuropsiquiatr 1994;52:17.
[17] Yusuf HR, Croft JB, Giles WH, Anda RF, Casper ML, Caspersen CJ, et al.
Leisure-time physical activity among older adults: United States, 1990.
Arch Intern Med 1996;156:13216.
[18] Cawthorne T. The physiological basis for head exercises. J Chart Soc
Physiother 1944;29:1067.
[19] Cooksey FS. Rehabilitation in vestibular injuries. Proc R Soc Med 1946;39:
2738.
[20] Hnsson EE, Mansson NO, Hkansson A. Effects of specific rehabilitation
for dizziness among patients in primary health care. A randomized
controlled trial. Clin Rehabil 2004;18:55865.
[21] Steckler A, McLeroy KR. The importance of external validity. Am J Public
Health 2008;98(1):910.
[22] Fortin M, Dionne J, Pinho G, Gignac J, Almirall J, Lapointe L. Randomized
controlled trials: do they have external validity for patients with multiple
comorbidities? Ann Fam Med 2006;4:1048.
[23] McMurdo ME, Roberts H, Parker S, Wyatt N, May H, Goodman C, et al.
Improving recruitment of older people to research through good practice.
Age Ageing 2011;40(6):65965.
[24] Rothwell PM. External validity of randomised controlled trials: to whom
do the results of this trial apply?. Lancet 2005;365:8293.
[25] Colledge NR, Wilson JA, Macintyre CC, MacLennan WJ. The prevalence and
characteristics of dizziness in an elderly community. Age Ageing 1994;
23(2):11720.
[26] Tinetti ME, Williams CS, Gill TM. Dizziness among older adults: a possible
geriatric syndrome. Ann Intern Med 2000;132(5):33744.
[27] Maarsingh OR, Dros J, Schellevis FG, van Weert HC, Bindels PJ, Horst HE.
Dizziness reported by elderly patients in family practice: prevalence,
incidence, and clinical characteristics. BMC Fam Pract 2010;11:2.
[28] Moraes SA, Soares WJ, Rodrigues RA, Fett WC, Ferriolli E, Perracini MR.
Dizziness in community-dwelling older adults: a population-based study.
Braz J Otorhinolaryngol 2011;77(6):6919.
Downloaded from ClinicalKey.com at ClinicalKey Global Guest Users November 05, 2016.
For personal use only. No other uses without permission. Copyright 2016. Elsevier Inc. All rights reserved.
34
[29] Logghe IHJ, Zeeuwe PEM, Verhagen AP, Wijnen-Sponselee RM, Willemsen
SP, Bierma-Zeinstra SM, et al. Lack of effect of Tai Chi Chuan in preventing
falls in elderly people living at home: a randomized clinical trial. J Am
Geriatr Soc 2009;57:705.
[30] Robinson KA, Dennison CR, Wayman DM, Pronovost PJ, Needham DM.
Systematic review identifies number of strategies important for retaining
study participants. J Clin Epidemiol 2007;60:75765.
[31] Shumway-Cook A. Vestibular rehabilitation: an effective, evidence-based
treatment. Portland: Vestibular Disorders Association (VEDA). http://
vestibular.org/sites/default/files/page_files/Vestibular%20Rehabilitation_0.
pdf. (accessed 08 August 2014).
[32] Alghadir AH, Iqbal ZA, Whitney SL. An update on vestibular physical
therapy. J Chin Med Assoc 2013;76(1):18.
[33] Whitney SL, Sparto PJ. Principles of vestibular physical therapy rehabilitation. NeuroRehabilitation 2011;29:15766.
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