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| Name | Class |
|---|---|
| University of Évora | OTHER |
| Comprehensive Health Research Center | OTHER |
| Sociedade Portuguesa de Esclerose Múltipla | UNKNOWN |
| Asociación de Familiares y Afectados de Esclerosis Múltiple |
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The purpose of this exploratory study is to evaluate the feasibility and acceptability of the "Active and Mindful" home-based mind-body exercise program for individuals diagnosed with Multiple Sclerosis (MS) in Portugal and Spain.
Multiple Sclerosis often leads to physical and psychological challenges that impact health-related quality of life. Mind-body exercise programs combined with remote supervision present an accessible, flexible alternative to traditional center-based rehabilitation. This study assesses the practicality of implementing a 9-month online intervention delivered via video-conferencing, focusing on recruitment rates, retention, participant attendance, and overall satisfaction. Secondarily, the study explores pre-to-post changes in clinical and psychological indicators such as perceived physical exertion and health-related quality of life.
Background:
Multiple Sclerosis (MS) is a chronic, progressive neurological condition that requires ongoing management to maintain physical functioning and psychological well-being. Exercising at home using digital health solutions offers a viable pathway to increase adherence and overcome logistical barriers (such as transportation or geographic isolation) often faced by clinical populations. This exploratory study investigates the "Active and Mindful" program, a remotely supervised, home-based intervention designed specifically to accommodate the functional variations of people living with MS.
Objectives:
Methodology:
The study utilized a non-randomized, single-group, interventional design spanning a total duration of 9 months. Individuals with MS were recruited via digital interest forms and institutional channels across Portugal (in collaboration with the Sociedade Portuguesa de Esclerose Múltipla - SPEM) and Spain (in collaboration with the Asociación de Familiares y Afectados de Esclerosis Multiple - AFAEM).
The intervention was structured into distinct functional tiers to ensure physical safety and progressive adaptation:
Data collection and Timeline:
Quantitative data and validated health surveys were administered at three distinct time points to capture the progression of the cohort:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active and Mindful Mind-Body Exercise Group | Experimental | People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active and Mindful Program | Other | An online exercise program (combining synchronous and asynchronous sessions) conducted in a small groups (3 to 8 participants) tailored to functional levels. Sessions were held twice a week for 9months, including physical fitness, Pilates, Tai-Chi, mindfulness, and relaxation techniques. In the final phase, asynchronous video resources on a web platform were introduced |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Percentage of participants recruited out of the total expressions of interest received. | Baseline (T0) |
| Retention Rate | Percentage of participants who completed the intervention and the final follow-up assessments | Post-intervention (T2 - 9 months) |
| Global Attendance Rate | Mean percentage of exercise sessions attended by the participants throughout the program. | Through the 9 month intervention |
| Program Satisfaction and Acceptability | Participant satisfaction scores measured through a feedback questionnaire (scored on a 1 to 5 Likert scale, where higher scores indicate higher satisfaction). | At the end of every training session throughout the 9-month intervention period. |
| Perceived Exertion (Borg RPE) | Assessment of physical effort intensity during exercise sessions using the Borg Rating of Perceived Exertion (RPE) scale 0-10. Higher scores indicate higher physical exertion. | At the end of every training session throughout the 9-month intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| General Health-Related Quality of Life (SF-36) | Generic health status questionnaire covering 8 domains. Subscale scores range from 0 to 100, where higher scores indicate better health status and quality of life. | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Multiple Sclerosis-Specific Quality of Life (MSQOL-54) |
| Measure | Description | Time Frame |
|---|---|---|
| State Mindfulness Scale (SMS) | Measurement of state mindfulness experienced during or immediately after intervention sessions using the State Mindfulness Scale. The SMS is a 21-item self-report measure with a 5-point Likert-type scale (1 = not at all to 5 = very well), comprising two subscales: State Mindfulness of Mind (15 items) and State Mindfulness of Body (6 items). Total scores range from 21 to 105, where higher scores reflect greater state mindfulness (better outcome). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora | Evora | 7000-727 | Portugal |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| UNKNOWN |
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|
Evaluation of MS-specific quality of life across physical and mental health composites. Scores range from 0 to 100, where higher scores represent superior quality of life. |
| Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Modified Fatigue Impact Scale (MFIS) | Assessment of the impact of fatigue on physical, cognitive, and psychosocial functioning using the Modified Fatigue Impact Scale (MFIS). Total score ranges from 0 to 84, where higher scores indicate a greater negative impact of fatigue. Scores above 38 indicate significant clinical fatigue. | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Hospital Anxiety and Depression Scale (HADS) | Evaluation of psychological distress using the Hospital Anxiety and Depression Scale (HADS), comprising two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale scores from 0 to 21, where higher scores indicate greater severity of symptoms (worse outcome). | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Activities-Specific Balance Confidence (ABC) | Self-reported scale measuring a patient's confidence in maintaining balance during various daily ambulatory activities. Scores range from 0% to 100%, where higher percentages indicate greater balance confidence. | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Mindfulness Attention Awareness Scale (MAAS) | Assessment of mindful presence and awareness in daily life using the Mindful Attention Awareness Scale (MAAS). Total score ranges from 1 to 6 (calculated as a mean of items), where higher scores indicate higher dispositional mindfulness. | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Interoceptive Awareness (MAIA) | Evaluation of body awareness and connection through the Multidimensional Assessment of Interoceptive Awareness (MAIA). It measures 8 subscales scored from 0 to 5, with higher scores indicating better interoceptive awareness and body trusting. | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Physical Activity Levels (IPAQ) | Assessment of total physical activity over the previous 7 days using the International Physical Activity Questionnaire (IPAQ). Outcomes are reported as continuous scores in MET-minutes/week or categorized into Low, Moderate, or High activity groups. | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Pain Severity and Interference (BPI) | Evaluation of pain intensity and its impact on daily functional activities using the Brief Pain Inventory (BPI). It generates two major subscales: Pain Severity (0-10) and Pain Interference (0-10), where higher scores denote worse pain and higher functional impairment. | Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |