The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue

Cairo University (CU)

Status: Completed

Conditions: Physical and Rehabilitation Medicine

Treatments: Other: cognition-targeted exercise; Behavioral: Cognitive behavioral therapy; Other: Standardized physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04699370

Cairo 2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

cognition-targeted exercise

Experimental group

Description:

The patients in this group will receive cognitive behavior therapy in addition to cognition-targeted exercise . Cognitive behavior therapy will be designed on the basis of van Kessel's model . The main objective of this treatment will be challenging all external factors (e.g. behavioral, cognitive, and affective factors) envisioned to play a role in the development and persistence of fatigue in MS patients. The treatment sessions will be directed individually. For Cognition- targeted exercise , all standardized physical therapy exercises will be performed in a time-contingent rather than in a symptom-contingent way .

Treatment:

Other: cognition-targeted exercise

Behavioral: Cognitive behavioral therapy

symptom-targeted exercise

Active Comparator group

Description:

The patients in this group will receive cognitive behavior therapy in addition to symptom-targeted exercise . Cognitive behavior therapy will be designed on the basis of van Kessel's model . The main objective of this treatment will be challenging all external factors (e.g. behavioral, cognitive, and affective factors) envisioned to play a role in the development and persistence of fatigue in MS patients. The treatment sessions will be directed individually. For symptom- targeted exercise, All Standardized physical therapy exercises will be performed in a symptom-contingent way ("Stop or adjust the exercise when it hurts").

Treatment:

Behavioral: Cognitive behavioral therapy

Other: Standardized physical therapy