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

AbstractPURPOSE:
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<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.
AuthorsNatalia A Ricci, Mayra C Aratani, Heloísa H Caovilla, Fernando F Ganança
JournalContemporary clinical trials (Contemp Clin Trials) Vol. 40 Pg. 26-34 (Jan 2015) ISSN: 1559-2030 [Electronic] United States
PMID25460341 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2014 Elsevier Inc. All rights reserved.
Topics
  • Aged
  • Aged, 80 and over
  • Comorbidity
  • Dizziness (rehabilitation)
  • Educational Status
  • Exercise Therapy (methods)
  • Female
  • Health Status
  • Humans
  • Male
  • Postural Balance
  • Research Design

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