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临床试验/NCT05585294
NCT05585294已完成不适用

The Effectiveness of Perturbation Exercises in Elderly Back Pain

Gulf Medical University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Fall risk

研究概览

简要总结

The aim of this study was to compare the effectiveness of land based versus water based perturbation exercises on the pain, disability, fear of falling, and fear avoidance beliefs in elderly participants. Overweight/obese subgroup was compared with healthy weight with chronic low back pain participants to investigate any effect on BMI on both interventions. The results of the study revealed that both exercise groups i.e., land and water based exercise had a significant reduction in pain level, fear of falling, fear avoidance belief related to work, disability and improved SLR.

详细描述

Twenty-four grouped into 12 per group participated water based and land based exercise protocol. Both groups were given McKenzie Method of exercises in 1st week based on the treatment-based classification (TBC) approach or personalized to the need of participants as per TBC.

Perturbation-based postural exercises were given to participants, which were performed on land or water for 6 weeks.

The perturbation based exercises were categorized into four levels, where level 1:static postural control, 2:dynamic postural control 3:Extremity loaded postural control and 4: cognitive task associated postural control. The perturbation were provided at shoulder and hip level, by intervention providers progressive enough to initiate anticipatory or compensatory postural adjustments.

Both groups were educated on pain assurance and spinal ergonomics feedback. The Outcomes were measured using a Visual analog scale, Oswestry disability index, Fear avoidance belief questionnaire, Straight leg raise, Modified fall efficacy scale, and Borg scale. The pain level were assessed for personalized progression from level 1 to level 4 progression of perturbation exercises.

Both the exercise groups of land and water showed improvement in measured clinical outcomes in terms of reduction in pain level, fear of falling, fear avoidance belief related to work, SLR, and disability. Water-based group showed additional benefits and significant improvement in fear avoidance belief related to physical activity and exercised with low rate of perceived exertion.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Outcome assessor unaware of what care was provided, and care was provided by other providers. Possibility of sequential trail is considered. The value of p will be adjusted depending the number of analysis made and stopping rule will be followed.

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain history of minimum 12 weeks duration in below labels
  • Participants with the diagnostic labels of spondylosis
  • Non-specific chronic low back pain
  • Back pain radiating to leg or sciatica
  • Subacute back pain

排除标准

  • Unstable blood pressure
  • Cardiac failure
  • Incontinence
  • Uncontrolled epilepsy
  • Open wounds
  • Acute infections
  • Neurological disorders
  • Orthopedic conditions affecting exercise participation in pool and land
  • Cardio-respiratory conditions affecting exercise participation in pool and land.

结局指标

主要结局

Fall risk

时间窗: 6 weeks

Fall risk of participants was assessed using the Modified fall efficacy scale (MFES), where Higher scores reflect more confidence and less fear of falling while lower scores reflect less confidence and more fear of falling.

Low back pain

时间窗: 6 weeks

Visual Analogue Scale (VAS) was used where 0 indicates no pain and 10 indicate extremely painful.

Physical activity associated fear avoidance behavior

时间窗: 6 weeks

The percentage of fear avoidance of behavior ranges from 0 to 100% where 0%-indicates no fear and 100%-indicate highest level of fear avoidance behavior.

Disability caused by the chronic low back pain

时间窗: 6 weeks

A standard Oswestry Disability Index (ODI) was used to evaluate the disability caused by the chronic low back pain. The lower the score lower disability and higher scores indicates that high level of disability associated with back pain.

次要结局

  • Rate of perceived exertion(6 weeks)
  • Impairment - Straight Leg Raise as hip joint range of motion(6 weeks)

研究者

发起方
Gulf Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Zaarour

Assistant Professor

Gulf Medical University

研究点 (2)

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