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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Challenges in conducting a randomized clinical trial of older people with chronic dizziness: Before, during and after vestibular rehabilitation

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Author(s):
Ricci, Natalia A. [1, 2, 3] ; Aratani, Mayra C. [1] ; Caovilla, Heloisa H. [1] ; Gananca, Fernando F. [1]
Total Authors: 4
Affiliation:
[1] Fed Univ Sao Paulo UNIFESP, Dept Otorhinolaryngol & Head & Neck Surg, Div Otoneurol, Sao Paulo - Brazil
[2] City Univ Sao Paulo UNICID, Masters Program Phys Therapy, Sao Paulo - Brazil
[3] City Univ Sao Paulo UNICID, Doctoral Program Phys Therapy, Sao Paulo - Brazil
Total Affiliations: 3
Document type: Journal article
Source: CONTEMPORARY CLINICAL TRIALS; v. 40, p. 26-34, JAN 2015.
Web of Science Citations: 3
Abstract

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 82Cooksey 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 < 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. (C) 2014 Elsevier Inc. All rights reserved. (AU)

FAPESP's process: 09/16908-6 - Effects of vestibular rehabilitation on balance control in older people with chronic vestibular disorder: a randomized trial
Grantee:Natalia Aquaroni Ricci
Support Opportunities: Scholarships in Brazil - Doctorate