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

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

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

Study Overview

• Status: Completed
• Conditions: Physical and Rehabilitation Medicine
• Intervention / Treatment: Other: cognition-targeted exercise; Behavioral: Cognitive behavioral therapy; Other: Standardized physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12613
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cognition-targeted exercise; 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 .	Other: cognition-targeted exercise; All Standardized physical therapy exercises will be performed in a time-contingent . Goal setting is essentially done together with the patient, focussing on functionality instead of fatigue relief. Progression to a next level of (more difficult) exercises will be preceded by an intermediate phase of motor imagery. The treating physical therapist will be advised to address patients' cognitions about their problems during the cognition-targeted exercise training, so that patients will have positive perceptions regarding their illness and treatment outcome. The treating physical therapist will be advised to discuss the patient's perceptions about each exercise. This include discussion of the anticipated consequences of the exercises and challenging the patient's cognitions in relation to the exercises; Behavioral: Cognitive behavioral therapy; In the first and second sessions, patients will learn about fatigue-related symptoms as well as Cognitive behavioral therapy and its effectiveness. The third and fourth sessions will be devoted on the introduction of behavioral strategies. The fifth session will introduce cognitive strategies to decrease fatigue. The last three sessions will be about how to adopt the proposed strategies consistently.
Active Comparator: symptom-targeted exercise; 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").	Behavioral: Cognitive behavioral therapy; In the first and second sessions, patients will learn about fatigue-related symptoms as well as Cognitive behavioral therapy and its effectiveness. The third and fourth sessions will be devoted on the introduction of behavioral strategies. The fifth session will introduce cognitive strategies to decrease fatigue. The last three sessions will be about how to adopt the proposed strategies consistently.; Other: Standardized physical therapy; The standardized physical therapy will consist of eight half-hour individualized face to face physiotherapy sessions, over a 4-week period. this program 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Fatigue Impact Scale	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.	pre-treatment , at 4-week,and after three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Work and Social Adjustment Scale	The Work and Social Adjustment Scale , which assessed fatigue-related impairment in relation to a number of areas of the person's life. The maximum score is 40 .lower score is better	pre-treatment , at 4-week,and after three months
Change in Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale , a commonly used self-report instrument for detecting states of depression and anxiety in patients with medical illnesses. scores of less than 7 indicate non-cases and high scores indicate more anxiety and depression	pre-treatment , at 4-week,and after three months
Change in Perceived Stress Scale	the Perceived Stress Scale will be included to assess whether the degree to which patients appraised situations in their lives as stressful changed after the intervention. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.	pre-treatment , at 4-week,and after three months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: January 2, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; exercise; Randomized controlled trial; Fatigue; Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: Cairo 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No