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

• ClinicalTrials.gov Identifier: NCT04699370
• Recruitment Status: Completed
• First Posted: January 7, 2021
• Last Update Posted: June 8, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ibrahim Moustafa, Cairo University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Physical and Rehabilitation Medicine	Other: cognition-targeted exercise; Behavioral: Cognitive behavioral therapy; Other: Standardized physical therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue: Randomized Controlled Trial
• Actual Study Start Date: January 1, 2021
• Actual Primary Completion Date: February 20, 2021
• Actual Study Completion Date: June 4, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in Work and Social Adjustment Scale [ Time Frame: pre-treatment , at 4-week,and after three months ]
   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
2. Change in Hospital Anxiety and Depression Scale [ Time Frame: pre-treatment , at 4-week,and after three months ]
   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
3. Change in Perceived Stress Scale [ Time Frame: pre-treatment , at 4-week,and after three months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Cairo University

Giza, Egypt, 12613

Sponsors and Collaborators

Cairo University

More Information

• Responsible Party: Ibrahim Moustafa, Associate professor, Cairo University
• ClinicalTrials.gov Identifier: NCT04699370
• Other Study ID Numbers: Cairo 2021
• First Posted: January 7, 2021
• Last Update Posted: June 8, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ibrahim Moustafa, Cairo University:

Randomized controlled trial; Multiple Sclerosis; Fatigue; Cognitive Behavioral Therapy; exercise

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Fatigue; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases