Clinical trial NCT04699370: The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue
Official title: The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical and Rehabilitation Medicine
Keywords: Randomized controlled trial
Multiple Sclerosis
Fatigue
Cognitive Behavioral Therapy
exercise
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Modified Fatigue Impact Scale
timeFrame: pre-treatment , at 4-week,and after three months
Secondary outcomes:
measure: Change in Work and Social Adjustment Scale
timeFrame: pre-treatment , at 4-week,and after three months
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: pre-treatment , at 4-week,and after three months
measure: Change in Perceived Stress Scale
timeFrame: pre-treatment , at 4-week,and after three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References: