- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Evora, Portogallo, 7000-727
- Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Active and Mindful Mind-Body Exercise Group
People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recruitment Rate
Lasso di tempo: Baseline (T0)
|
Percentage of participants recruited out of the total expressions of interest received.
|
Baseline (T0)
|
|
Retention Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
General Health-Related Quality of Life (SF-36)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
State Mindfulness (SMS)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie autoimmuni demielinizzanti, SNC
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Sclerosi multipla
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Esercizio
Altri numeri di identificazione dello studio
- 101134389
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Sclerosi multipla
-
Sanko UniversityCompletatoMULTIPLE SCLEROSIS | BILANCIO | VALIDITÀ | AFFIDABILITÀTurchia (Türkiye)