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: 1. To determine the feasibility of the program through quantitative benchmarks, specifically recruitment efficiency, attrition (retention rate), and global session attendance. 2. To evaluate participant acceptability and satisfaction with the synchronous group dynamic. 3. To collect preliminary exploratory data on patient-reported outcomes, including perceived exertion during sessions and health-related quality of life domains. 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: * Synchronous Phase: Live, exercise sessions conducted via the ZOOM platform in small groups ranging from 3 to 8 participants, organized according to their baseline functional capacity. Sessions were held twice a week and incorporated physical fitness, adapted Pilates, Tai-Chi, mindfulness protocols, and guided relaxation techniques. * Asynchronous Phase: During the latter half of the program, participants were progressively introduced to and integrated with digital video resources hosted on a dedicated web platform, promoting independent home practice. * Session Monitoring: To assess the specific feasibility of these pre-recorded video sessions, participants completed study-specific session evaluation forms. Data collection and Timeline: Quantitative data and validated health surveys were administered at three distinct time points to capture the progression of the cohort: * Baseline(T0): Collected before the first exercise session to record sociodemographic characteristics, clinical history, and initial status. * Midpoint Assessment (T1): Conducted at approximately 4.5 months to monitor early compliance and initial shifts in perceived effort. * Post-test (T2): Completed at month 9 to evaluate the terminal outcomes, overall compliance, retention metrics, and final system satisfaction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
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
Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora
Evora, Portugal
Recruitment Rate
Percentage of participants recruited out of the total expressions of interest received.
Time frame: Baseline (T0)
Retention Rate
Percentage of participants who completed the intervention and the final follow-up assessments
Time frame: Post-intervention (T2 - 9 months)
Global Attendance Rate
Mean percentage of exercise sessions attended by the participants throughout the program.
Time frame: 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).
Time frame: 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.
Time frame: At the end of every training session throughout the 9-month intervention period.
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.
Time frame: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Multiple Sclerosis-Specific Quality of Life (MSQOL-54)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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