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临床试验/NCT01512342
NCT01512342已完成2 期

Pacing Activity Self-management for Patients With Chronic Fatigue Syndrome: Randomized Controlled Clinical Trial

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
33
试验地点
2
主要终点
the change in score on the Canadian Occupational Performance Measure (COPM)

研究概览

简要总结

Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS.

详细描述

Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome (CFS), it is examined whether physical behavior and health status of patients with CFS improve in response to a pacing self-management program. The effects of pacing will be compared with those observed when applying relaxation therapy to patients with CFS.

According to the power calculation, 36 patients fulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome (CFS) will be randomized to either 3 weeks of pacing activity self-management or relaxation therapy. Both treatment groups will receive 3 weekly sessions spread over 3 consecutive weeks. All treatments will be delivered by occupational therapists or physiotherapists. One treatment session lasts for about 45 minutes each.

Outcome measures include the Canadian Occupational Performance Measure (COPM), Medical Outcomes Short Form 37 Health Status Survey (SF-36), Checklist Individual Strength (CIS), CFS Symptom List and autonomic activity at rest and following 3 activities of daily living (writing a standardized test on a laptop computer, ironing, and climbing 26 flights of stairs). For measuring autonomic activity, the Nexus 10 device (Mind Media, the Netherlands) will be used. Skin conductance, body temperature, heart rate, blood volume pressure and heart rate variability will be measured continuously in real time during a 2 minutes period, with the patient sitting on a chair (back supported and hands resting on legs). Electrodes will be placed on the left hand in all patients.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • age range between 18 and 65 years of age
  • female gender
  • willing to sign informed consent form
  • fulfilling the 1994 Centre for Disease Control and Prevention criteria for the diagnosis of chronic fatigue syndrome

排除标准

  • Not fulfilling each of the inclusion criteria listed above.

结局指标

主要结局

the change in score on the Canadian Occupational Performance Measure (COPM)

时间窗: measured at baseline (week 1) and post-treatment (week 5)

well-validated, reliable and frequently used outcome measure semi-structered interview

次要结局

  • the change in subscale scores on the Medical Outcomes Short Form 37 Health Status Survey (SF-36)(measured at baseline (week 1) and post-treatment (week 5))
  • the change in Ckecklist Individual Strength (CIS)(measured at baseline (week 1) and post-treatment (week 5))
  • the change in CFS Symptom List(measured at baseline (week 1) and post-treatment (week 5))
  • the change in autonomic activity at rest and following 3 activities of daily living(measured at baseline (week 1) and post-treatment (week 5))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jo Nijs

Associate professor

Vrije Universiteit Brussel

研究点 (2)

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