Multiple SclerosisHCB_MSNCT07028879
Effectiveness of a One-year Group Program for Fatigue Management in Minimally Impaired People With Multiple Sclerosis
A study testing Fatigue management program in people with Multiple Sclerosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fatigue management program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2025to 13 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Patients who, despite meeting the inclusion criteria (6.1), are unable to attend the sessions (due to availability, geographic location, or other personal reasons) will be included in the comparison group. or
- Those who show a lack of attendance at sessions of <80% over the course of a year or <75% in one of the quarters.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a One-year Group Program for Fatigue Management in Minimally Impaired People With Multiple Sclerosis: a Non-randomized, Open-label, Controlled Clinical Trial
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.
Read more
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
- Being tested
- Fatigue management program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue management programProcedure or surgery
Combination of Occupational Therapy and Physiotherapy strategies and sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Combination of Occupational Therapy and Physiotherapy strategies and sessions in-person, 2 days-week, during 12 months. Receives: Procedure: Fatigue management program |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (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.
The four-item Spanish-language version (SEMCD-S) was developed to measure changes in self-efficacy in program participants and have been used in a numerous evaluations of chronic disease self-management programs. The score for each item is the number circled. If two consecutive numbers are circled, code the lower number (less self-efficacy). If the numbers are not consecutive, do not score the item. The score for the scale is the mean of the eight items. If more than two items are missing, do not score the scale. Higher number indicates higher self-efficacy.
Measured: (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)
The International Physical Activity Questionnaire (IPAQ) measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Test score:
- Vigorous physical activity: 8 METs x minutes x days per week
- Moderate physical activity: 4 METs x minutes x days per week
- Walking: 3.3 x minutes x days per week.
Then add the three values obtained:
TOTAL = Vigorous physical activity + Moderate physical activity + walking
Measured: (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).
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Scoring the PSQI: each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
Measured: (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).
The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale, with seven items relating to anxiety and seven relating to depression. It was created to measure specifically to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Measured: (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.
The EQ-5D-5L is a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Measured: (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 quality of life by the SF-36 questionnaire.
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: (12 months after the start of the program) and at mid-term follow-up (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start13 Mar 2025
- Primary completion14 Mar 2026
- Study completion13 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028879
- Sponsor's protocol ID
- HCB/2025/0049
- Acronym
- HCB_MS
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a One-year Group Program for Fatigue Management in Minimally Impaired People With Multiple Sclerosis: a Non-randomized, Open-label, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07028879
- Acronym / sponsor ID
- HCB_MS / HCB/2025/0049
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 13 Sep 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Fatigue management programCombination of Occupational Therapy and Physiotherapy strategies and sessions in-person, 2 days-week, during 12 months. |
| Control group | No intervention | – |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Patients who, despite meeting the inclusion criteria (6.1), are unable to attend the sessions (due to availability, geographic location, or other personal reasons) will be included in the comparison group. or
- Those who show a lack of attendance at sessions of <80% over the course of a year or <75% in one of the quarters.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue management programCombination of Occupational Therapy and Physiotherapy strategies and sessions. | Procedure or surgery | Intervention group |
Primary outcome
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).
Time frame: (12 months after the start of the program) and at mid-term follow-up (18 months)
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.
6 secondary outcomes
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.
Time frame: (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)
Time frame: (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).
Time frame: (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).
Time frame: (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.
Time frame: (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 quality of life by the SF-36 questionnaire.
Time frame: (12 months after the start of the program) and at mid-term follow-up (18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue management program in people with Multiple Sclerosis, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: (12 months after the start of the program) and at mid-term follow-up (18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.