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

June 12, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Baseline (T0)
Percentage of participants recruited out of the total expressions of interest received.
Baseline (T0)
Retention Rate
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General Health-Related Quality of Life (SF-36)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
State Mindfulness (SMS)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catarina Alexandra Nunes Martins

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Évora
Comprehensive Health Research Center
Sociedade Portuguesa de Esclerose Múltipla
Asociación de Familiares y Afectados de Esclerosis Múltiple

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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