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临床试验/NCT04079894
NCT04079894已完成不适用

Physical Activity in the Elderly Spine Patient

Malin Eleonora av Kák Gustafsson, MD1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2019年6月26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
206
试验地点
1
主要终点
Accelerometer-data

研究概览

简要总结

Purpose Physical activity reduces the risk of several diseases of the body and the mind1, 2 and can help the elderly maintain physical abilities and self-efficacy in daily life1. The overall purpose of the project is to provide clinicians with a tool to objectively assess physical activity in daily life and thus provide an informed basis for individualized care of elderly patients with spine disease. We would like to introduce this tool to a broad population of elderly patients with low back pain to give an overview of the range and variability in physical activity. We will also look into a method for accurate step count in spine disorders where patients have severe walking impairment due to affected lumbar nerve roots.

详细描述

Background Spine disorders, such as low back pain, come with considerable physical limitations, and participation in social events and everyday life can be burdensome2. Efforts to increase physical ability and involvement in everyday life are essential to maintain or heighten quality of life in spite of chronic pain.

Some spine disorders can negatively affect lumbar nerve roots, where the symptoms radiate to the legs. Lumbar Spinal Stenosis (LSS) is one of many chronic spinal pain syndromes, with specific structural abnormalities that can be detected on MRI scans, including narrowing of the spinal canal. Its clinical presentation involves radiation of pain and sensory disturbance to buttocks and legs while walking3. Although there is considerable variation in the diagnostic criteria used, spinal stenosis is common in the elderly, and a recent review reported prevalences between 11% and 38% depending on criteria and study population4. The disease considerably constrains patients' walking ability, which means that patients experience problems with exercise and leisure activities5. Physical activity is significantly reduced, and a recent study shows that individuals with LSS spend 82% of their day sitting or lying down, compared to 35% in healthy adults over 60 years6, leading to an increase in lifestyle diseases such as hypertension7.

Thus, the aging patient with a spine disorder such as LSS or low back pain has to cope with the functional limitations of their disease, as well as the natural decline of function with age1. It is therefore very important for this group of patients that healthcare providers can support their pursuit of an active life. In order to do so, it is necessary for healthcare providers to have reliable knowledge about the individual patients' physical activity and functional impairment in daily life. Such information is typically collected through interviews, physical exams, questionnaires, and the occasional objective test, which only provide indirect, predominantly subjective, information about physical activity in everyday life.

Emerging technology in the form of wearable sensors is breaking new ground and becoming more widespread. Existing research has used sensors such as accelerometers to quantify and differentiate time spent standing, walking, cycling, and sitting or lying down, with high accuracy8. Previous studies have already established that accelerometer-based step counts in elderly people are accurate9-13, but they are influenced by 1) the physical location of the accelerometer on the body14, 15, 2) the method used to transform raw accelerometer data16, and 3) traits of the person wearing it, such as gait speed, use of assistive devices, and age17. As LSS can alter gait characteristics18 and can give severe walking impairment, accelerometer measures of step count developed for healthy adults could be inaccurate in these patients. Since walking impairment is the most prominent disability in LSS, we see the need for a tested and valid measure of walking activity in daily living.

The study consists of two parts, each with a corresponding aim: Part I) develop and examine the validity of an accelerometer-based method of measuring walking activity in daily living in patients with LSS. Part II) uncover objectively identifiable profiles of physical activity in elderly patients with LSS and/or low back pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • Other disease limiting walking rather than neurogenic claudication, such as cardiopulmonary diseases, vascular claudication, recent operation or fracture of spine, pelvis or leg, severe hip or knee arthrosis (not efficiently threated by hip/knee replacement), systemic muscular diseases, impaired vision.
  • Traits which interfere with the participants' gait pattern, such as habitual use of walking aids during walking at home and away from home, drop foot.
  • Eligibility Criteria for Patients with LBP:
  • Informed written consent.
  • Fluent in Danish in reading and speaking.
  • Suffering from Low Back Pain
  • Low Back Pain is the primary source of pain and disability.
  • Eligibility Criteria for Healthy Participants:
  • Healthy participants will be >60 years old and have the same exclusion criteria as patients, with the addition of not suffering from neurogenic claudication.

结局指标

主要结局

Accelerometer-data

时间窗: 3 months post-surgery

Raw accelerometer data collected for 7 consecutive days, by one accelerometer (Axivity AX3) secured by band-aid. The placement of the accelerometer will be decided in phase A.

The Oswestry Disability Index

时间窗: 3 months post-surgery.

Questionnaire on function in patients with lower back pain. Score 0-100% where 100% is severe disability

The Self-Paced Walking Test

时间窗: 3 months post-surgery

Walking on a pre-determined rute until stopped by symptoms of LSS. Recording time and distance walked.

次要结局

  • Hospital Anxiety and Depression Scale(At baseline)
  • Mean Change from Baseline in The Self-Paced Walking Test at 3 Months Post-Surgery(3 months post-surgery)
  • Visual Analog Scale for Back and Leg Pain(3 months post-surgery)
  • Mean Change from Baseline in The Swiss Spinal Stenosis Questionnaire at 3 Months Post-Surgery(3 months post-surgery)
  • Mean Change from Baseline in Accelerometer Measures at 3 Months Post-Surgery(3-months post-surgery)
  • The Swiss Spinal Stenosis Questionnaire(3 months post-surgery)
  • Hospital Anxiety and Depression Scale. Rating anxiety and depression seperately on an ordinal scale from 0-21, 21 indicating worst result.(3 months post-surgery)
  • Mean Change from Baseline in The Oswestry Disability Index at 3 months Post-Surgery(3 months post-surgery)

研究者

发起方
Malin Eleonora av Kák Gustafsson, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Malin Eleonora av Kák Gustafsson, MD

Ph.D.-student

Spine Centre of Southern Denmark

研究点 (1)

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