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临床试验/NCT03645616
NCT03645616已完成不适用

Reliability of Functional Tests for Individuals With Chronic Low Back Pain.

Alessandro Haupenthal2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Distance traveled in meters.

研究概览

简要总结

Back pain is often accompanied by changes in function. The performance of individuals with their backs on their wills may become more functional. It is believed that the test will present good to excellent reliability in individuals with chronic back pain. From this, it can be used in the clinic to verify the functional capacity of these individuals.

详细描述

This study will be performed to verify the reliability of the functional tests for individuals with back pain. A study in which individuals with back pain will be assessed on the first day and after the interval of seven days. They should perform the 6-minute walk test and answer some questionnaires such as the Roland Morris - disability questionnaire, the IPAQ - physical activity level questionnaire and Numeric Rating Scale, after the tests will be performed Timed 10-Meter Walk Test and 30 Second Sit to Stand Test. To avoid a random error, a minimum sample size of 30 participants is required. For statistical analysis, Shapiro-Wilk test will be used for data normalization and the reliability between measurements will be calculated through do Intraclass Correlation Coefficients, standard error of measurement and Minimal Detectable Change. There were no studies in the literature and recorded in the Clinical Trials that evaluated the reliability of these tests for individuals with chronic low back pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

盲法说明

All data were color coded to guarantee that the investigator who processed the data was blinded to the conditions.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes aged 20 to 65 years and low back pain for more than 3 months.

排除标准

  • Acute pain of back pain that disables the performance of the tests.
  • Pregnancy.
  • Neoplasms.
  • Known heart, lung or metabolic diseases.
  • Hypotension (BP < 90 x 60 mmHg) or stage II hypertension (BP > 140 x 90 mmHg), medicated or not.
  • Fall or faint in the previous two months.
  • Have not undergone any spinal surgery.
  • Have not had neuromuscular impairment in the last three months and who need help to follow the instructions.

研究组 & 干预措施

Functional Tests

Experimental

Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.

干预措施: 6-minute walk test (Diagnostic Test)

Functional Tests

Experimental

Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.

干预措施: 10 meters walk test (Diagnostic Test)

Functional Tests

Experimental

Participants undertook 6-minute walk test, 10 meters walk test and 30 second sit to stand test.

干预措施: 30 Second Sit to Stand Test (Diagnostic Test)

结局指标

主要结局

Distance traveled in meters.

时间窗: The individual will perform 42 minutes of testing, two walking tests of 6 minutes plus 30 minutes of rest

Measured by the 6-minute walk test. Individuals should walk in a 30 meter corridor for 6 uninterrupted minutes.

次要结局

  • Gait Speed(5 minutes)
  • Functional lower extremity strength(30 seconds.)
  • Pain intensity(5 minutes)
  • Functional Incapacity(10 minutes)
  • Physical activity level(10 minutes)

研究者

发起方
Alessandro Haupenthal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alessandro Haupenthal

Principal Investigator

Universidade Federal de Santa Catarina

研究点 (2)

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