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

NCT04699370 | Completed DMC

• 1 other identifier: Cairo 2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Physical and Rehabilitation Medicine

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (2)

cognition-targeted exercise

EXPERIMENTAL

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; Behavioral: Cognitive behavioral therapy

symptom-targeted exercise

ACTIVE COMPARATOR

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; Other: Standardized physical therapy

Interventions

cognition-targeted exercise OTHER

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

cognition-targeted exercise

Cognitive behavioral therapy BEHAVIORAL

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.

cognition-targeted exercise; symptom-targeted exercise

Standardized physical therapy OTHER

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.

symptom-targeted exercise

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Motor Activity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.

Study Record Dates

• First Submitted: January 2, 2021
• First Posted: January 7, 2021
• Study Start: January 1, 2021
• Primary Completion: February 20, 2021
• Study Completion: June 4, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)