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Clinical Trials/NCT04699370
NCT04699370
Completed
Not Applicable

The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue: Randomized Controlled Trial

Cairo University1 site in 1 country60 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical and Rehabilitation Medicine
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Change in Modified Fatigue Impact Scale
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Introduction: Multiple sclerosis (MS) has a wide range of physiological and neuropsychological symptoms. Over 75% of MS patients complain about fatigue, which for many is one of their most debilitating symptoms, having a substantial impact on their quality of life and ability to carry out day-to-day tasks. Previous investigations on the effectiveness of different types of psychotherapy on MS fatigue are extremely limited. The aim of this study was to investigate the added value of cognition-targeted exercise versus symptom-targeted exercise for Multiple Sclerosis fatigue

Detailed Description

Patients with fatigue symptoms (score of ≥5 on Fatigue Scale) will be randomly assigned into experimental (n=30) and control (n=30) groups. The subjects in the experimental group will receive eight 50-minute sessions of weekly cognitive behavior therapy based on van Kessel's model in addition cognition-targeted exercise program , whereas the patients in the control group will receive eight 50-minute sessions of weekly CBT in addition to standardized physiotherapy program . A standardized program of physiotherapy exercises will consist of twice-weekly supervised general aerobic, strengthening and flexibility exercise sessions. This exercise program is reflective of the general exercises typically undertaken within routine clinical practice.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
June 4, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Moustafa

Associate professor

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of multiple sclerosis by a neurologist which incorporate clinical features with magnetic resonance scanning.
  • Being within normal or average dysfunction and excluding those scoring ≤6 in the Expanded Disability Status Scale (EDSS);
  • Being identified as a case level of fatigue; fatigue score of 4 or greater on the Fatigue Scale (FS);

Exclusion Criteria

  • Patients with any serious psychological disorders (including psychotic disorders or active substance abuse), or those with any chronic illness that may be contributing to fatigue were excluded.

Outcomes

Primary Outcomes

Change in Modified Fatigue Impact Scale

Time Frame: pre-treatment , at 4-week,and after three months

The Modified Fatigue Impact Scale is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. Items on the Modified Fatigue Impact Scale are aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total Modified Fatigue Impact Scale score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities.

Secondary Outcomes

  • Change in Work and Social Adjustment Scale(pre-treatment , at 4-week,and after three months)
  • Change in Hospital Anxiety and Depression Scale(pre-treatment , at 4-week,and after three months)
  • Change in Perceived Stress Scale(pre-treatment , at 4-week,and after three months)

Study Sites (1)

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