Efficacy of Vestibular Physiotherapy Against Multi-component Exercise in Functional Improvement in the Elderly": Pilot Study of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery
研究概览
简要总结
Loss of vestibular function occurs normally with healthy aging but can produce symptoms that reduce motor skills and cause falls. vestibular physical therapy (VPH) exercises are a specific approach to reducing imbalances. The multicomponent therapeutic physical exercise (ME) is an effective non-pharmacological strategy for the improvement of physical condition.
Objective: to determine the efficacy of ME versus VPH for gait improvement. Material and method: a randomized clinical trial was carried out with two intervention groups , applying it to one VPH group and the other ME.
The participants were residents of Geriatric Centers in the province of Seville, Spain with a score between 4 and 9 points according to the "Short Physical Performance Battery" scale (SPPB).
详细描述
This pilot study is a controlled and randomized clinical trial (simple ER) with two groups in parallel, comparing the combination of a multi-component therapeutic exercise protocol (ME) versus vestibular exercises (VPH) in over 70 years. The trial was approved by the Ethics Committee on Research with code 2410-N-19 and the study was conducted in accordance with the Helsinki Declaration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females over 70 years of age.
- •Subjects with a score between 4 and 9 points on the. "Short Physical Performance Battery"" (SPPB) scale
排除标准
- •Patients unable to walk unaided or those who do not exceed the previous evaluation in SPPB.
- •Polypharmacological patients (combined use of beta blockers, sulpiride or betahistin) were also excluded.
研究组 & 干预措施
VESTIBULAR EXERCISE at home telerehabilitation
-
The vestibular exercises were performed with the indications of a physical therapist, in sessions of about 20 minutes with 5 times per week (Monday to Friday) consisting of 5 repetitions ensuring the following were not overworked:
-
Head and eye movements while sitting.
-
Head and body movements while sitting.
-
Paused exercises.
-
Combined exercises of modifications on rungs, unstable surfaces and walking exercises.
干预措施: Experimental: VESTIBULAR EXERCISE (Procedure)
MULTICOMPONENT EXERCISE at home telerehabilitaion
- A 6-week multi-component therapeutic physical exercise program was carried out. The ministerial guide and the "Vivifrail" consensus was followed (25, 26). There were 5 daily sessions per week (Monday to Friday), each lasting approximately 45 minutes. These sessions were conducted following the instructions of a physical therapist. VIVIFRAIL exercises are intended to be used over a progression period of up to 12 weeks, with combined exercises by days in cardiovascular aerobic balance strength and flexibility.
干预措施: MULTICOMPONENT EXERCISE (Procedure)
VESTIBULAR EXERCISE in clinic
-
The vestibular exercises were performed with the indications of a physical therapist, in sessions of about 20 minutes with 5 times per week (Monday to Friday) consisting of 5 repetitions ensuring the following were not overworked:
-
Head and eye movements while sitting.
-
Head and body movements while sitting.
-
Paused exercises.
-
Combined exercises of modifications on rungs, unstable surfaces and walking exercises.
干预措施: Experimental: VESTIBULAR EXERCISE (Procedure)
multi component exercise in clinic
- A 6-week multi-component therapeutic physical exercise program was carried out. The ministerial guide and the "Vivifrail" consensus was followed (25, 26). There were 5 daily sessions per week (Monday to Friday), each lasting approximately 45 minutes. These sessions were conducted following the instructions of a physical therapist. VIVIFRAIL exercises are intended to be used over a progression period of up to 12 weeks, with combined exercises by days in cardiovascular aerobic balance strength and flexibility.
干预措施: MULTICOMPONENT EXERCISE (Procedure)
结局指标
主要结局
Movement Capacity: SPPB (Short Physical Performance Battery) Physical Function Valuation Battery
时间窗: Change from Baseline at 6 weeks
The SPPB fitness rating battery consists of three parts: Balance rating, 4 metre gait assessment rating and the Time up and go test (TUG). From 0 (bad) to 12 (well) there is a score which describes de functionality
Test Time up and Go
时间窗: Change from Baseline at 6 weeks
The participants try to stand up and wlak 3 metres and return sitting. We must record the time. 1) This is a continuous quantitative variable measured in seconds.
Speed test
时间窗: Change from Baseline at 6 weeks
Speed test. A participants walking speed over a 4 metre distance. This is a continuous quantitative variable measured in meters per second (m/s).
次要结局
未报告次要终点
研究者
MARINA LOPEZ GARCIA
Associate Professor
University of Seville