Effectiveness of a One-year Group Program for Fatigue Management in Minimally Impaired People With Multiple Sclerosis

NCT ID: NCT07028879

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2026-09-13

Brief Summary

Fatigue is one of the most common symptoms, experienced by between 50% and 100% of people with multiple sclerosis (MS), and contributes significantly to the consequences of MS and perceived disability in the daily lives of those with the condition. On the one hand, practicing different forms of physical exercise (PE) has demonstrated effective management of perceived fatigue, and the literature strongly supports the need for regular exercise in patients with MS.

On the other hand, energy conservation programs and cognitive-behavioral interventions have demonstrated improvements in self-efficacy, participation in social life, perceived control over their disease, and a reduction in the perceived impact of fatigue, particularly in the physical and psychosocial domains of life.

Therefore, in this study, a physical therapist and an occupational therapist will conduct a one-year group program focused on educational and practical learning of techniques and strategies, keeping in mind that lifestyle changes take time to become permanent.

It is important to highlight that, as MS generally presents in early adulthood, there is growing interest in exploring rehabilitation techniques very early after diagnosis or in minimally affected MS patients (0-4.5 on the EDSS), we are therefore interested in exploring this program in this population group with MS, the majority of whom are actively employed, and evaluating the effects on perceived fatigue severity, quality of life, incidental and planned exercise, sleep quality, anxiety and depression, and perceived self-efficacy.

Study participants will be recruited by the neuroimmunology team at Hospital Clínic de Barcelona, who will select those who meet the inclusion criteria from the multiple sclerosis patients seen. Those patients who, despite meeting the inclusion criteria, are unable to attend the sessions (due to availability, geographic location, or other personal reasons) will form the comparison group. Therefore, there is no random assignment in this study. For this study, a total sample of 28 patients will be divided into three groups of 7, 7, and 14 participants, respectively. The last group will not receive treatment and will be used as a control group. Patients who do receive treatment will be assigned to groups on a first-come, first-served basis, and the therapeutic program will be the same for both groups. This separation is done to improve the quality of the intervention by allowing participants greater interaction in small groups.

Participants who must withdraw from the study for reasons beyond their control, having completed less than a third of the program, and participants who, despite being considered good candidates, are unable to attend the sessions for work, personal, or geographic reasons, will be evaluated at the beginning and end of the study using the same scales as the control group to compare the results obtained.

The sessions will be held at the day hospital for neurodegenerative diseases at the Hospital Clínic de Barcelona, twice a week: one physiotherapy session and one occupational therapy session. Implicit assessments will be conducted at the start of the program, at 6 months, one year, and 6 months after completion of the program.

There are no risks beyond the risks inherent in sports practice, which may exist in physical therapy sessions.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Combination of Occupational Therapy and Physiotherapy strategies and sessions in-person, 2 days-week, during 12 months.

Group Type: EXPERIMENTAL

Fatigue management program

Intervention Type: PROCEDURE

Combination of Occupational Therapy and Physiotherapy strategies and sessions.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fatigue management program

Combination of Occupational Therapy and Physiotherapy strategies and sessions.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with multiple sclerosis referred by the Neuroimmunology and Multiple Sclerosis Unit at Hospital Clínic de Barcelona who present symptoms of limiting fatigue.
• Independence to perform basic activities of daily living.
• Maximum EDSS score of 4.5.

• Those who show a lack of attendance at sessions of <80% over the course of a year or <75% in one of the quarters.

Exclusion Criteria

• Severe comorbidity due to other conditions, including severe depressive symptoms, or substance use that may impact the individual's self-perception.
• MS flare within 30 days prior to inclusion.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clinic de Barcelona

Barcelona, Spain, Spain

Countries

Spain

Other Identifiers

HCB/2025/0049

Identifier Type: -

Identifier Source: org_study_id