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临床试验/NCT03882333
NCT03882333已完成不适用

Effects of Acute Exercise on Pain and Human Movement - a Randomised Controlled Study in Patients With Chronic Pain and Healthy Controls

Dalarna University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2018年12月12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
82
试验地点
1
主要终点
Kinematic measures of human movement during functional gait sequences

研究概览

简要总结

The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement con-trol between patients with chronic musculoskeletal pain compared to healthy controls.

详细描述

The aim of this research project is to evaluate the effect of an acute exercise intervention on pain intensity and movement control. It also aims to investigate potential differences in movement control between patients with chronic musculoskeletal pain compared to healthy controls. All tests will be conducted at Dalarna University.

After the initial baseline tests, participants will be randomised to either acute exercise intervention group or to a control group not performing any intervention groups (both patients and controls will be randomised to intervention or control). If randomised to the control group, participants rests corresponding to the time it takes to perform the intervention (30 min), and then preform the post-intervention tests similar as the intervention group.

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
None

入排标准

年龄范围
18 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion criteria for participants with chronic pain:
  • •Men and women, age 18-67 years,
  • •good ability to understand written and verbal information and instruction given in Swedish,
  • •chronic (>3 months) musculoskeletal pain or chronic widespread pain.
  • •Inclusion criteria for healthy controls:
  • •Men and women, age 18-67 years,
  • •good ability to understand written and verbal information and instruction given in Swedish.

排除标准

  • •For participants with chronic pain
  • •chronic pain caused by malignancies or systemic diseases, other physical conditions that affects functional abilities and implies use of walking aid in-door,
  • •pregnancy after week 12, childbirth within the last 3 months or
  • •spinal surgery.
  • •For healthy controls:
  • •chronic (>3 months) or acute pain of any cause,
  • •other physical conditions that affects functional abilities, and implies use of walking aids in-door,
  • •pregnancy after week 12, childbirth in the last 3 months or
  • •spinal surgery.

研究组 & 干预措施

Acute exercise

Experimental

Acute exercise (bicycle at stationary cycle).

干预措施: Acute exercise (Other)

Rest

No Intervention

Rest (lying down or sitting in a chair) for 30 minutes, i.e. same time duration as in experimental arm.

结局指标

主要结局

Kinematic measures of human movement during functional gait sequences

时间窗: 30 minutes (before and after the acute exercise intervention)

Objective measures of movement control using sophisticated wearable sensors (accelerometer-based APDM-sensors applied at participants wrists, ankles, chest and head) during walking in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test: participants listens to a recording of a voice that presents random series of digits between 1 to 9 with two seconds apart. The participants will be instructed to respond as quickly and accurately as possible, repeating the digit before the last one in the sequence.). Lumbar trunk rotations (degrees) will specifically be evaluated while many other kinematic variables (walking speed, step length, step width etc) will be analyzed with factor analyz-es to reduce data variables to relevant data domains, such as gait stability. Data will be aggregated as means and variances.

Muscle activity

时间窗: 30 minutes (before and after the acute exercise intervention)

Evaluation of back muscle activity using electromyographics (EMG) during walking as in outcome 1, i.e. in 1) self-selected normal gait speed, 2) a brisk gait speed, 3) self-selected normal gait speed with a concurrent cognitive task (1-back test). Participants will be instrumented with surface-EMG (Delsys Incorporated, Massachusetts) electrodes applied bilateral at participants back and neck muscles. Back and neck spatial and temporal muscle activity (EMG amplitudes) representing repeated gait cycles will be aggregated to one cycle; factor analyzes may be applied to reduce data variables to relevant data domains. Data will be presented as means and variances.

次要结局

  • Self-rated pain using the Visual Analogue Scale (VAS scale).(30 minutes (before and after the acute exercise intervention))

研究者

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

Bjorn Ang

Associate Professor

Karolinska Institutet

研究点 (1)

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