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临床试验/NCT05323838
NCT05323838进行中(未招募)不适用

Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia on Physical Activity, Quality of Life and Immunoneuroendocrine Response.

University of Extremadura1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
140
试验地点
1
主要终点
Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI)

研究概览

简要总结

The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.

详细描述

The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Fibromyalgia and/or Chronic Fatigue Syndrome diagnosis by rheumatologists or internal medicine professionals.
  • Age not less than 40 years old and not more than 65 years old.

排除标准

  • Suffering from diagnosed "major depression".
  • Suffer diagnosed multiple chemical sensitivity.
  • Corticosteroid treatment or anti-cytokine therapies.
  • Periodically carry out programmed therapeutic physical activity in the two months prior to the accelerometry tests.

结局指标

主要结局

Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI)

时间窗: During the intervention, at day 1.

State-Trait Anxiety Inventory (STAI) is a self-reported, scientifically validated questionnaire that measures perceived anxiety. The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

Differences in fear of Coronavirus Disease (COVID-19) using the Fear COVID-19 Scale (FCV-19S)

时间窗: During the intervention, at day 1.

The Fear of COVID-19 Scale (FCV-19S) is used to identify and intervene early, psychologically, in people with high values of fear of COVID-19. This one-dimensional scale is made up of seven items with a 5-point Likert response ranging from 1 (strongly disagree) to 5 (strongly agree) and the total tables can range between 7 and 35 points. The higher the score, the greater the fear of COVID-19 infection.

Differences in perceived stress using The Perceived Stress Scale (PSS)

时间窗: During the intervention, at day 1.

The Perceived Stress Scale (PSS) is a self-reported, scientifically validated questionnaire that measures perceived stress. This scale is a self- report instrument that evaluates the level of perceived stress during the last month, and consists of 14 items with a 5-point response scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10, and 13 (in the following manner: 0 = 4, 1 = 3, 2 = 2, 3 = 1, and 4 = 0) and subsequently adding the 14 item scores. A higher score indicates a higher level of perceived stress.

Determination of immuno-neuroendocrine parameters (cytokines, catecholamines, and stress hormones)

时间窗: Through study completion, an average of 2 year

Cytokines (IL-8, IL-10), catecholamines (such as epinephrine, and norepinephrine) as well as stress hormones (serotonin and cortisol), were analyzed by competitive inhibition enzyme immunoassays (ELISA)

Differences in perceived pain using the Brief Pain Inventory (BPI)

时间窗: During the intervention, at day 1.

Brief Pain Inventory (BPI) is a self-reported, scientifically validated questionnaire that measures perceived pain. The BPI starts with a screening question, asking about the presence of pain and a body chart is used to indicate painful regions as well as the worst region. These items aren´t evaluated. This is followed by the core BPI items: the rating scales for pain severity and interference. Numerical rating scales from 0 to 10 are used for all items. The anchors for pain severity scales are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whilst the interference anchors are 0 = 'no interference' and 10 = 'interferes completely'.

Differences in subjective quality of sleep using The Pittsburgh Sleep Quality Index (PSQI)

时间窗: During the intervention, at day 1.

The Pittsburgh Sleep Quality lndex (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21 " indicating severe difficulties in all areas.

Differences in subjective quality of life using The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ)

时间窗: During the intervention, at day 1.

The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ) This is a 26-item tool in which the respondent is asked to indicate the frequency of adopting 26 positively stated lifestyle habits using a Likert-type scale (1=Never or rarely, 2=Sometimes, 3=Often, and 4 = Always).

Differences in perceived depression using the Beck's Depression Inventory (BDI)

时间窗: During the intervention, at day 1.

Beck's Depression Inventory (BDI) is a self-reported, scientifically validated questionnaire that measures perceived depression. Each of the 21 items on the BDI measures the presence and severity of a symptom of depression by requiring a self-rating from 0 to 3. Mild (low) scores are less than 4; moderate (medium) is between 14 and 20, and severe 21 and above. Unless otherwise indicated, the use of "mild," "moderate," and "severe" levels of depression throughout the remainder of this chapter will refer to the aforementioned ranges.

Differences in perceived pain using the Brief Fatigue Inventory (BFI)

时间窗: During the intervention, at day 1.

The Brief Fatigue Inventory (BFI) has nine items, with the items measured on 0-10 numeric rating scales. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and"now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The interference items are measured on a 0 -10 scale, with 0 beings "does not interfere" and 10 being "completely interferes."

Differences in perceived anxiety related to Coronavirus Disease (COVID-19) using the Coronavirus Anxiety Scale (CAS)

时间窗: During the intervention, at day 1.

The Coronavirus Anxiety Scale is a brief mental health screener that can be used to identify cases of dysfunctional anxiety related to COVID-19. The items measure physiologically-based symptoms that are aroused with coronavirus-related information and thoughts using a 5-point time anchored scale (0=not at all to 4=nearly every day over the last 2 weeks).

Objective differences in physical activity, sedentary lifestyle and sleep using the accelerometer technique (ActiGraph)

时间窗: Up to 1 week

An accelerometer is a small device, like a wristwatch, used to measure physical activity level, patterns of activity, sedentary levels, sleep patterns, and the expenditure of calories consumed, basal and total Metabolic Equivalent of Task (METs) used as an assessment of the metabolism of the person wearing it.

次要结局

未报告次要终点

研究者

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

Eduardo Otero Calderón

Staff Scientist, Research

University of Extremadura

研究点 (1)

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