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

24 juin 2026 mis à jour par: Catarina Alexandra Nunes Martins

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Active and Mindful Mind-Body Exercise Group
People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program
Autre: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recruitment Rate
Délai: Baseline (T0)
Percentage of participants recruited out of the total expressions of interest received.
Baseline (T0)
Retention Rate
Délai: Post-intervention (T2 - 9 months)
Percentage of participants who completed the intervention and the final follow-up assessments
Post-intervention (T2 - 9 months)
Global Attendance Rate
Délai: Through the 9 month intervention
Mean percentage of exercise sessions attended by the participants throughout the program.
Through the 9 month intervention
Program Satisfaction and Acceptability
Délai: At the end of every training session throughout the 9-month intervention period.
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)
Délai: At the end of every training session throughout the 9-month intervention period.
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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
General Health-Related Quality of Life (SF-36)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Activities-Specific Balance Confidence (ABC)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)
Hospital Anxiety and Depression Scale (HADS)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
State Mindfulness Scale (SMS)
Délai: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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).
Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Catarina Alexandra Nunes Martins

Collaborateurs

University of Évora
Comprehensive Health Research Center
Sociedade Portuguesa de Esclerose Múltipla
Asociación de Familiares y Afectados de Esclerosis Múltiple

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2024

Achèvement primaire (Réel)

1 avril 2025

Achèvement de l'étude (Réel)

1 avril 2025

Dates d'inscription aux études

Première soumission

12 juin 2026

Première soumission répondant aux critères de contrôle qualité

12 juin 2026

Première publication (Réel)

17 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 101134389

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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