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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Active and Mindful Program

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Evora, Portugal, 7000-727
    • Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Active and Mindful Mind-Body Exercise Group; People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program

Other: Active and Mindful Program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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)
Anxiety and Depression Symptoms (HADS)	Evaluation of psychological distress using the Hospital Anxiety and Depression Scale (HADS), split into Anxiety (HADS-A) and Depression (HADS-D) subscales. Each subscale scores from 0 to 21.	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Mindfulness (SMS)	Measurement of physical and mental mindfulness levels specifically experienced during or immediately after the intervention sessions using the State Mindfulness Scale (SMS). Higher scores reflect greater state mindfulness.	Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

Collaborators and Investigators

• Sponsor: Catarina Alexandra Nunes Martins
• Collaborators: University of Évora; Comprehensive Health Research Center; Sociedade Portuguesa de Esclerose Múltipla; Asociación de Familiares y Afectados de Esclerosis Múltiple

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Mindfulness; Functional Mobility; Acceptability; Online Intervention; Feasibility Study; Mind-body exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 101134389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No