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

NCT07028879 | Active Not Recruiting

• 1 other identifier: HCB/2025/0049
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To determine the effectiveness of this program after completion (12 months after the start of the program) and at mid-term follow-up (18 months) in reducing the severity of perceived fatigue by the Modified Fatigue Impact Scale (MFIS).

  This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items while the abbreviated version has 5 items. The abbreviated version can be used if time is limited, but the full-length version has the advantage of generating subscales. Administration time is approximately 5-10 minutes for the full-length version and 2-3 minutes for the abbreviated version. The MFIS is a structured, self-report questionnaire that the patient can generally complete with little or no intervention from an interviewer. However, patients with visual or upper extremity impairments may need to have the MFIS administered as an interview. Interviewers should be trained in basic interviewing skills and in the use of this instrument. The total score for the MFIS is the sum of the scores for the 21 items.

  (12 months after the start of the program) and at mid-term follow-up (18 months)

Secondary Outcomes (6)

• To determine the effectiveness of this program after completion (12 months after the start of the program) and at mid-term follow-up (18 months) in improving self-efficacy by the 4-item Spanish chronic disease self - efficacy.

  (12 months after the start of the program) and at mid-term follow-up (18 months)

• To determine the effectiveness of this program after completion (12 months after the start of the program) and at mid-term follow-up (18 months) in improving incidental and planned exercise by the International Physical Activity Questionnaire (IPAQ)

  (12 months after the start of the program) and at mid-term follow-up (18 months)

• To determine the effectiveness of this program after completion (12 months after the start of the program) and at mid-term follow-up (18 months) in improving sleep quality by the Pittsburgh Sleep Quality Index (PSQI).

  (12 months after the start of the program) and at mid-term follow-up (18 months)

• To determine the effectiveness of this program after completion (12 months after the start of the program) and at mid-term follow-up (18 months) in Reducing anxiety and depression levels by the Hospital Anxiety and Depression Scale (HADS).

  (12 months after the start of the program) and at mid-term follow-up (18 months)

• To determine the effectiveness of this program after completion (12 months after the start of the program) and at mid-term follow-up (18 months) in reducing the impact of fatigue on health status by the EQ-5D-5L.

  (12 months after the start of the program) and at mid-term follow-up (18 months)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Procedure: Fatigue management program

Control group

NO INTERVENTION

Interventions

Fatigue management program PROCEDURE

Combination of Occupational Therapy and Physiotherapy strategies and sessions.

Intervention group

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe comorbidity due to other conditions, including severe depressive symptoms, or substance use that may impact the individual's self-perception.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Spain, 08036, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 19, 2025
• Study Start: March 13, 2025
• Primary Completion: March 14, 2026
• Study Completion (Estimated): September 13, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)