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

CompletedNot a drug-phase studyMS (type not specified)NCT07654699

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 19 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Active and Mindful Program

What it measured

Main measures

  • Recruitment Rate

    Baseline (T0)

    Feasibility
  • Retention Rate

    Post-intervention (T2 - 9 months)

    Feasibility
  • Global Attendance Rate

    Through the 9 month intervention

    Physical function
  • Program Satisfaction and Acceptability

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

    Quality of life (reported by participants)Feasibility
  • Perceived Exertion (Borg RPE)

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

    Physical function

Other measures (9)

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

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

    Quality of life (reported by participants)
  • Multiple Sclerosis-Specific Quality of Life (MSQOL-54)

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

    Quality of life (reported by participants)
  • Modified Fatigue Impact Scale (MFIS)

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

    Thinking and memoryFatigue
  • Hospital Anxiety and Depression Scale (HADS)

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

    Mood and sleep
  • Activities-Specific Balance Confidence (ABC)

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

    Walking and mobility
  • Mindfulness Attention Awareness Scale (MAAS)

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

    Thinking and memory
  • Interoceptive Awareness (MAIA)

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

  • Physical Activity Levels (IPAQ)

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

    Physical function
  • Pain Severity and Interference (BPI)

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

    Pain

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Mar 2024

    2. Main results due

      Apr 2025

    3. Finished

      Apr 2025

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