Ruiz-Rios Maitane, Lekue Asier, Pinedo-López Jon, Tous-Espelosin Mikel, Arratibel-Imaz Iñaki, García-Tabar Ibai, Maldonado-Martin Sara
GIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Exercise Research Group, Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain.
Bioaraba Health Research Institute, Physical Activity, Exercise, and Health Group, Vitoria-Gasteiz, Basque Country, Spain.
Contemp Clin Trials Commun. 2023 Oct 6;36:101213. doi: 10.1016/j.conctc.2023.101213. eCollection 2023 Dec.
Unilateral and bilateral peripheral vestibular hypofunction (UVH and BVH) often complains of dizziness, gaze, and balance disturbances. There is a lack of evidence on exercise intervention in UVH and BVH patients. To investigate the effect of an eight-week supervised multicomponent exercise program in people suffering from UVH or BVH in comparison with a control group doing conventional vestibular rehabilitation at home.
This longitudinal, controlled, randomized, prospective, single-blinded, two-arm, parallel intervention study will include 66 adults (≥18 years old) with chronic UVH or BVH. Participants will be randomly assigned to an exercise intervention group or an attention control group. Participants will be assessed at baseline, after a two-month intervention period, and after a six-month follow-up. The primary variable will be the balance, measured by the dynamic posturography sensory organization test and the Modified Dynamic Gait Index test. Secondary outcome variables will include cardiorespiratory fitness (peak cardiopulmonary exercise test), body composition (bioimpedance and anthropometric variables), physical activity level and sleep quality (accelerometry), health-related quality of life (Dizziness Handicap Inventory questionnaire), emotional state (Beck Depression and Anxiety Inventory questionnaires), and blood pressure monitoring.
This study will try to answer whether in people with UVH/BVH, an adjuvant program of multicomponent exercise will help the prognosis of this population.
ClinicalTrials.gov, identifier [NCT05192564]. Verification date: April 2023.
单侧和双侧外周前庭功能减退（UVH和BVH）常伴有头晕、凝视和平衡障碍。目前缺乏关于UVH和BVH患者运动干预的证据。本研究旨在比较为期八周的多组分运动监督训练计划与在家进行传统前庭康复的对照组相比，对UVH或BVH患者的影响。
本纵向、对照、随机、前瞻性、单盲、双臂平行干预研究将纳入66名患有慢性UVH或BVH的成年人（≥18岁）。参与者将被随机分配到运动干预组或注意力控制组。参与者将在基线、两个月的干预期后以及六个月的随访后进行评估。主要变量将是平衡能力，通过动态姿势描记感觉组织测试和改良动态步态指数测试来衡量。次要结局变量将包括心肺适能（峰值心肺运动测试）、身体成分（生物电阻抗和人体测量变量）、身体活动水平和睡眠质量（加速度计）、健康相关生活质量（头晕残障量表问卷）、情绪状态（贝克抑郁和焦虑量表问卷）以及血压监测。
本研究将试图回答在UVH/BVH患者中，多组分运动辅助计划是否有助于改善该人群的预后。
ClinicalTrials.gov，标识符 [NCT05192564]。验证日期：2023年4月。
