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临床试验/NCT05002062
NCT05002062已完成不适用

The Influence of Cognitive Behavioral Therapy on Fatigue, Cognition and Inflammatory Biomarkers in Multiple Sclerosis Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月21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
入组人数
40
试验地点
1
主要终点
Level of primary fatigue

研究概览

简要总结

There is a rising concern about quality of life of multiple sclerosis (MS) patients has emerged. Cognitive dysfunction with primary fatigue and there correlation to the level of disease inflammatory process has got great interest in MS research .

The aim of the present study was to examine the influence of using a computer-based cognitive behavioral therapy on primary fatigue, cognitive dysfunction, and inflammatory biomarkers for patients with MS.

Patients and methods A total of 40 MS patients (Expanded Disability Status Scale<5) were divided into two groups, both groups are suffering cognitive decline (using RehaCom software to assess attention/concentration, memory and reaction behavior) with primary fatigue according to the Fatigue Severity Scale (FSS>36). Patients with depression and sleep problems were excluded from the study. Patients in both groups have elevated serum levels of tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ).

Patients in (G1) underwent conventional physical therapy program for MS including aerobic training, resistive training and a flexibility program, patients in (G2) underwent an intensive computer-based cognitive program for attention, concentration, memory and reaction behavior using the RehaCom software.

The conventional physical therapy interventions for both (G1) sustained for three months, 45 minutes to 1 hour, 3 times/week. The computer-based cognitive behavioral therapy for patients in (G2) was prescribed as following (45 minutes to 1 hour a session, 3 times/week for continues three months).

详细描述

This study was done to to examine the influence of using a computer-based cognitive behavioral therapy on primary fatigue, cognitive dysfunction, and inflammatory biomarkers for patients with MS. This study was conducted in the time period between December 2020 till May 2021.

  1. Subjects Selection:

Forty MS patients were selected from Neurology Department Faculty of Medicine, Cairo University out-patient clinic , Multiple Sclerosis Research Unit, Cairo University and from Faculty of Physical Therapy ,Cairo University out-patient clinic. The patients were diagnosed and referred from a neurologist. All the patients were referred from a neurologist as a clinically definite MS according to Mcdonald criteria. The diagnosis was confirmed by MRI. The patients were assigned into two equal groups (Conventional physical therapy program)(G1) & ( Computer-based cognitive behavioral therapy)(G2).

  • Inclusion criteria:

  • All types and representations of MS patients were included in this study. - The age of the patients ranged from 20-45 years. - All the patients subjected to a standard neurological examination before participating in the study( sensory, motor, coordination , balance, gait and fundus examination).

  • All the patients were free from any other neurological problems.

  • Multiple sclerosis patients were subdivided into two equal groups (Conventional physical therapy program)(G1) & ( Computer-based cognitive behavioral therapy)(G2).

  • All included patients for both groups complained from fatigue for more than three months with total score of FSS ≥ 36.

  • All included patients complained of a cognitive decline for more than three months ( including attention, concentration or memory problems according to the RehaCom scores)

  • All the patients were ambulatory with mild to moderate disability according to the expanded disability status scale (EDSS) ≤ 5(Ambulatory without aid or rest for 200 meters).

  • Serum levels of tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) were elevated in all recruited patients for both groups.

  • All the patients were medically stable with absent or mild hemiparetic, ataxic, sensory or motor manifestations.

  • The main complain for all patients in both groups is the sense of fatigue and varying degrees of cognitive dysfunction.

  • All recruited MS Patients kept on their medications as glucocorticoids, amantadine , betaferon , hypnotics and modafinil throughout the study.

  • All patients were educated .

  • Exclusion criteria:

The patients were excluded when they met one of the following criteria:

  • Severe visual, verbal or acoustic impairments that may interfere with cognition testing,
  • Serious chronic illness that could interfere with or modify assessment or treatment outcomes.
  • Low leukocyte count & elevated ESR as this interfere with cytokine levels.
  • Secondary causes of fatigue including severe depression ( beck depression inventory (BDI ≥ 21) and sleep disturbance ( Epworth sleepiness scale (ESS ≥ 12)
  • Inability to complete questionnaires study outcome measure as in severe cognitive impairment and illiteracy.
  • Magnetic resonance imaging (MRI) of the brain showed plaques within the cingulate gyrus, insula , temporo-basal cortical areas or diffuse patchy frontal lesions as they usually complain from cognitive impairment independent of fatigue.
  1. Instrumentations & Procedures :

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
Single (Participant)

盲法说明

Sealed Envelopes

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All types and representations of MS patients were included in this study. - The age of the patients ranged from 20-45 years. - All the patients subjected to a standard neurological examination before participating in the study( sensory, motor, coordination , balance, gait and fundus examination).
  • •All the patients were free from any other neurological problems.
  • •Multiple sclerosis patients were subdivided into two equal groups, (Conventional physical therapy program group)(G1) & Computer-based Cognitive training program (G2).
  • •All patients in both groups complained from fatigue for more than two months with total score of FSS ≥
  • •All patients in both groups complained from varying degrees of cognitive decline persisted for more than 3 months.
  • •All the patients were ambulatory with mild to moderate disability according to the expanded disability status scale (EDSS) ≤ 5(Ambulatory without aid or rest for 200 meters).
  • •Main complain for all patients is sense of fatigue with varying degrees of cognitive decline.
  • •All the patients were medically stable with absent or mild hemiparetic, ataxic, motor or sensory manifestations.
  • •All patients were educated .

排除标准

  • •Severe visual, verbal or acoustic impairments that may interfere with cognition testing,
  • •Serious chronic illness that could interfere with or modify assessment.
  • •Low leukocyte count & elevated ESR as this interfere with cytokine levels.
  • •Secondary causes of fatigue including severe depression ( beck depression inventory (BDI ≥ 21) and sleep disturbance ( Epworth sleepiness scale (ESS ≥ 12)
  • •Inability to complete questionnaires study outcome measure as in severe cognitive impairment and illiteracy.

研究组 & 干预措施

G1 ( Conventional Physical Therapy Program group)

Sham Comparator

Patients in G1 underwent conventional physical therapy program continued for 3 months, included (aerobic training 20 minutes, resistive training for 15 minutes and flexibility program for 15 minutes).

The whole treatment session lasted from 50 minutes to one hour, 3 times per week for 3 consecutive months.

干预措施: Conventional physical therapy program (Other)

G2 ( Computer-based Cognitive Therapy group)

Active Comparator

Patients in G2 underwent Computer-based cognitive training continued for 3 months, included (attention/concentration, memory and reaction behavior training).

The whole treatment session timing lasted 50 minutes to one hour, 3 times per week for 3 consecutive months.

干预措施: "RehaCom" computer-based cognitive training in addition to Conventional physical therapy program (Device)

G2 ( Computer-based Cognitive Therapy group)

Active Comparator

Patients in G2 underwent Computer-based cognitive training continued for 3 months, included (attention/concentration, memory and reaction behavior training).

The whole treatment session timing lasted 50 minutes to one hour, 3 times per week for 3 consecutive months.

干预措施: Conventional physical therapy program (Other)

结局指标

主要结局

Level of primary fatigue

时间窗: Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

Level of fatigue is assessed using the Fatigue severity scale (FSS) , It is valid and reliable scale used to assess fatigue severity in MS patients. It is self reported questionnaire consisted of nine sentences. A list of statements/questions is provided. These statements are related to the different aspects of fatigue and how it affects the body.Grading of the scale range from " one to seven". Grade (seven) indicate that the patient strongly agrees with a particular statement. Grade (one) indicate the patient strongly disagree to this particular statement (Debouverie et al., 2002). At the end of assessment , if the added total scores were above 36. This indicated that the patient suffer from MS-related fatigue.

Level of Attention/concentration

时间窗: Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

Rehacom software is used to assess pre and post treatment cognitive function domains including level of Attention/concentration. Higher scores of attention/concentration indicated better cognitive function and vice versa.

Figural Memory

时间窗: Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

Rehacom software is used to assess pre and post treatment cognitive function domains including figural memory. Higher scores of immediate figural memory indicated better cognitive function and vice versa.

Mental Reaction behavior

时间窗: Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

Rehacom software is used to assess pre and post treatment cognitive function domains including Mental Reaction behavior. Higher scores of mental reaction behavior indicated better cognitive function and vice versa.

Serum levels of Tumor Necrosis Factor-alpha (TNF-alpha) and Interferon-gamma(INF-gamma)

时间窗: Changes from baseline to pre-intervention, Changes from Pre-intervention to immediately post intervention

The Quantikine Human TNF-alpha \& IFN-gamma Immunoassay ELISA kit . It is a 3.5 or 4.5 hour solid phase ELISA designed to measure human TNF-alpha \& IFN-gamma in cell culture supernates, serum, and plasma. (TNF-alpha) and (INF-gamma) results are measured in pg/ml, elevated levels of circulating TNF-α \& IFN-gamma indicate that the case is deteriorating or progressing.

次要结局

未报告次要终点

研究者

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

Engy Badreldin Saleh Moustafa, PhD

Lecturer of P.T for neuromuscular disorders and its surgery

Cairo University

研究点 (1)

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