Elsevier

Contemporary Clinical Trials

Volume 40, January 2015, Pages 26-34
Contemporary Clinical Trials

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

https://doi.org/10.1016/j.cct.2014.11.002Get rights and content

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 & 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.

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 evidence-based 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 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.

Section snippets

Material and methods

This is a process evaluation of a randomized controlled trial with a 3 month follow-up designed to verify the effectiveness of VR on older people with chronic dizziness. The study was approved by the Federal University of São 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 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),

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

Acknowledgments

The study was supported by São Paulo Research Foundation (FAPESP, São 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.

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