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

12. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active and Mindful Mind-Body Exercise Group
People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment Rate
Tidsramme: Baseline (T0)
Percentage of participants recruited out of the total expressions of interest received.
Baseline (T0)
Retention Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
General Health-Related Quality of Life (SF-36)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Anxiety and Depression Symptoms (HADS)
Tidsramme: 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), 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
State Mindfulness (SMS)
Tidsramme: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Catarina Alexandra Nunes Martins

Samarbejdspartnere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2024

Primær færdiggørelse (Faktiske)

1. april 2025

Studieafslutning (Faktiske)

1. april 2025

Datoer for studieregistrering

Først indsendt

12. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 101134389

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Kliniske forsøg med Multipel sclerose

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