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

NCT07654699 | Completed

• 1 other identifier: 101134389
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Mind-body exercise; Feasibility Study; Acceptability; Online Intervention; Mindfulness; Functional Mobility

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Percentage of participants recruited out of the total expressions of interest received.

  Baseline (T0)

• Retention Rate

  Percentage of participants who completed the intervention and the final follow-up assessments

  Post-intervention (T2 - 9 months)

• Global Attendance Rate

  Mean percentage of exercise sessions attended by the participants throughout the program.

  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).

  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.

  At the end of every training session throughout the 9-month intervention period.

Secondary Outcomes (9)

• General Health-Related Quality of Life (SF-36)

  Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

• Multiple Sclerosis-Specific Quality of Life (MSQOL-54)

  Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

• Modified Fatigue Impact Scale (MFIS)

  Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

• Anxiety and Depression Symptoms (HADS)

  Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

• Activities-Specific Balance Confidence (ABC)

  Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

Other Outcomes (1)

• State Mindfulness (SMS)

  Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)

Study Arms (1)

Active and Mindful Mind-Body Exercise Group

EXPERIMENTAL

People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program

Other: Active and Mindful Program

Interventions

Active and Mindful Program OTHER

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

Active and Mindful Mind-Body Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Significant medical comorbidities that impact or prevent safe exercise participation;
• Pregnant women.

Sponsors & Collaborators

• Catarina Alexandra Nunes Martins: lead
• University of Évora: collaborator
• Comprehensive Health Research Center: collaborator
• Sociedade Portuguesa de Esclerose Múltipla: collaborator
• Asociación de Familiares y Afectados de Esclerosis Múltiple: collaborator

Study Sites (1)

Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora

Evora, 7000-727, Portugal

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, PhD Student

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

PT (1)