Multiple SclerosisNCT07654699
Active and Mindful - A Mind-Body Programme for People With Multiple Sclerosis: a Feasibility Study Protocol
A study testing Active and Mindful Program in people with Multiple Sclerosis, run by Catarina Alexandra Nunes Martins at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Active and Mindful Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Significant medical comorbidities that impact or prevent safe exercise participation;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora
Evora, 7000-727
About this study
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.
Read the 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:
- 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Active and Mindful Program
- Keywords
- Multiple Sclerosis, Mind-body exercise, Feasibility Study, Acceptability, Online Intervention, Mindfulness, Functional Mobility
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active and Mindful ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| Active and Mindful Mind-Body Exercise Group | Experimental | People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program Receives: Other: Active and Mindful Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Percentage of participants recruited out of the total expressions of interest received.
Measured: Baseline (T0)
Retention Rate
Percentage of participants who completed the intervention and the final follow-up assessments
Measured: Post-intervention (T2 - 9 months)
Global Attendance Rate
Mean percentage of exercise sessions attended by the participants throughout the program.
Measured: Through the 9 month intervention
Program Satisfaction and Acceptability
Participant satisfaction scores measured through a feedback questionnaire (scored on a 1 to 5 Likert scale, where higher scores indicate higher satisfaction).
Measured: At the end of every training session throughout the 9-month intervention period.
Perceived Exertion (Borg RPE)
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.
Measured: At the end of every training session throughout the 9-month intervention period.
Secondary outcomes (9)
General Health-Related Quality of Life (SF-36)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Multiple Sclerosis-Specific Quality of Life (MSQOL-54)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Modified Fatigue Impact Scale (MFIS)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Hospital Anxiety and Depression Scale (HADS)
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).
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Activities-Specific Balance Confidence (ABC)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Mindfulness Attention Awareness Scale (MAAS)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Interoceptive Awareness (MAIA)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Physical Activity Levels (IPAQ)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Pain Severity and Interference (BPI)
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.
Measured: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Mar 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catarina Alexandra Nunes Martins
- Sponsor type
- University, hospital or other
- Collaborators
- University of Évora, Comprehensive Health Research Center, Sociedade Portuguesa de Esclerose Múltipla, Asociación de Familiares y Afectados de Esclerosis Múltiple
- Responsible party
- Sponsor-investigator, Catarina Alexandra Nunes Martins, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654699
- Sponsor's protocol ID
- 101134389
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active and Mindful - A Mind-Body Programme for People With Multiple Sclerosis: a Feasibility Study Protocol
- ClinicalTrials.gov ID
- NCT07654699
- Acronym / sponsor ID
- 101134389
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Mind-body exercise, Feasibility Study, Acceptability, Online Intervention, Mindfulness, Functional Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Catarina Alexandra Nunes MartinsUniversity, hospital or other
- Collaborators
- University of Évora, Comprehensive Health Research Center, Sociedade Portuguesa de Esclerose Múltipla, Asociación de Familiares y Afectados de Esclerosis Múltiple
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active and Mindful Mind-Body Exercise Group | Experimental | Other: Active and Mindful ProgramPeople with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Significant medical comorbidities that impact or prevent safe exercise participation;
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active and Mindful ProgramAn 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 | Other | Active and Mindful Mind-Body Exercise Group |
Primary outcome
Recruitment Rate
Time frame: Baseline (T0)
Percentage of participants recruited out of the total expressions of interest received.
Retention Rate
Time frame: Post-intervention (T2 - 9 months)
Percentage of participants who completed the intervention and the final follow-up assessments
Global Attendance Rate
Time frame: Through the 9 month intervention
Mean percentage of exercise sessions attended by the participants throughout the program.
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).
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.
9 secondary outcomes
General Health-Related Quality of Life (SF-36)
Time frame: 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)
Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
Hospital Anxiety and Depression Scale (HADS)
Time frame: 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)
Mindfulness Attention Awareness Scale (MAAS)
Time frame: 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)
Physical Activity Levels (IPAQ)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active and Mindful Program in people with Multiple Sclerosis, run by Catarina Alexandra Nunes Martins at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Baseline (T0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.