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- Ensayo clínico NCT07654699
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Evora, Portugal, 7000-727
- Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Active and Mindful Mind-Body Exercise Group
People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment Rate
Periodo de tiempo: Baseline (T0)
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Percentage of participants recruited out of the total expressions of interest received.
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Baseline (T0)
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Retention Rate
Periodo de tiempo: Post-intervention (T2 - 9 months)
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Percentage of participants who completed the intervention and the final follow-up assessments
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Post-intervention (T2 - 9 months)
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Global Attendance Rate
Periodo de tiempo: Through the 9 month intervention
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Mean percentage of exercise sessions attended by the participants throughout the program.
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Through the 9 month intervention
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Program Satisfaction and Acceptability
Periodo de tiempo: At the end of every training session throughout the 9-month intervention period.
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Participant satisfaction scores measured through a feedback questionnaire (scored on a 1 to 5 Likert scale, where higher scores indicate higher satisfaction).
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At the end of every training session throughout the 9-month intervention period.
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Perceived Exertion (Borg RPE)
Periodo de tiempo: At the end of every training session throughout the 9-month intervention period.
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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.
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At the end of every training session throughout the 9-month intervention period.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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General Health-Related Quality of Life (SF-36)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Multiple Sclerosis-Specific Quality of Life (MSQOL-54)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Modified Fatigue Impact Scale (MFIS)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Anxiety and Depression Symptoms (HADS)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Activities-Specific Balance Confidence (ABC)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Mindfulness Attention Awareness Scale (MAAS)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Interoceptive Awareness (MAIA)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Physical Activity Levels (IPAQ)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Pain Severity and Interference (BPI)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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State Mindfulness (SMS)
Periodo de tiempo: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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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.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Colaboradores e Investigadores
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Finalización primaria (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Esclerosis múltiple
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del estudio
- 101134389
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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