Active and Mindful - A Mind-Body Programme for People With Multiple Sclerosis: a Feasibility Study Protocol

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:

• To determine the feasibility of the program through quantitative benchmarks, specifically recruitment efficiency, attrition (retention rate), and global session attendance.
• To evaluate participant acceptability and satisfaction with the synchronous group dynamic.
• 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.

Inclusion criteria

• Adult patients diagnosed with Multiple Sclerosis living in Portugal or Spain;
• Expanded Disability Status Scale (EDSS) score below 8;
• First to register on the online inscription survey (subject to limited spots)
• Time availability to comply with the session schedules;
• Access to compatible digital devices with visual feedback (Camera) and reliable internet connectivity;
• Ability to install and use the ZOOM platform with the camera turned on.

Exclusion criteria

• Significant medical comorbidities that impact or prevent safe exercise participation;
• Pregnant women.