Sport, Rehabilitation and Nutrition in Multiple Sclerosis: An Innovative Multidisciplinary High Impact Intervention for the Lifestyle Change

Status unknownNot a drug-phase studyMS (type not specified)NCT04881422

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • B-HIPE (Brief High Impact Preparatory Experience)

What it measured

Main measures

  • FS-36 Health Related Quality of Life (HRQoL)

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

    Quality of life (reported by participants)
  • The Fatigue Severity Scale (FSS)

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

    Fatigue
  • Food frequency questionnaire (FFQ)

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

Other measures (5)

  • MSIS29- Multiple Sclerosis Impact Scale

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

  • MOS Sleep Scale (MOSS)

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

    Mood and sleep
  • Restless Legs Scale (RLS)

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

  • Six minute walking test (6MWT)

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

    Walking and mobilityPhysical function
  • Hospital Anxiety and Depression Scale (HADS)

    Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)

    Mood and sleep

Who could take part

MS (type not specified) · 18 to 70 · EDSS 1 to 7.5

Show the full criteria

Inclusion criteria

* aged 18 to 70 years * EDSS ranging from 1 to 7.5. * pwMS with who are on a western diet * stabilized medical therapy and clinical conditions * pwMS with a motor control of upper limbs sufficient to maneuver a tiller

Exclusion criteria

* Heavy smoking, alcohol and drugs abuse * severe cognitive impairment * dysphagia and/or comorbidities requiring protected environments and specific medical assistance * blindness and severe visual disturbances (included severe nystagmus)

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

About this trial

In the sponsor's words

Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS. The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.

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History

    1. Started

      Jul 2018

    2. Main results due

      Dec 2021

    3. Finished

      Jun 2022

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