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

Autor(es)

Ricci, Natalia A. ^{[1, 2, 3]} ; Aratani, Mayra C. ^[1] ; Caovilla, Heloisa H. ^[1] ; Gananca, Fernando F. ^[1]

Afiliação do(s) autor(es)

^[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

• Tipo de documento: Artigo Científico
• Fonte: CONTEMPORARY CLINICAL TRIALS; v. 40, p. 26-34, JAN 2015.
• Citações Web of Science: 3

Resumo

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)

• Processo FAPESP: 09/16908-6 - Efeitos da reabilitação vestibular no equilíbrio corporal de idosos vestibulopatas crônicos: ensaio clínico randomizado
• Beneficiário: Natalia Aquaroni Ricci
• Modalidade de apoio: Bolsas no Brasil - Doutorado