Multiple Sclerosis Fitness Intervention Training With Pilates Exercises

CompletedNot a drug-phase studyMS (type not specified)NCT04011579

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • MSFIT

What it measured

Main measures

  • Change in Timed Up & Go (TUG)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Walking and mobility

Other measures (19)

  • Change in Timed 25-Foot Walk (T25FW)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Disability progressionWalking and mobility
  • Change in Ambulation Index (AI)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Walking and mobility
  • Change in 2-Minutes Walking Test (2WT)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Walking and mobility
  • Change in Technology Acceptance Model (TAM)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

  • Change in Client Satisfaction Questionnaire-8 (CSQ-8)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Quality of life (reported by participants)
  • Change in Telehealth Satisfaction Scale (TeSS)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Quality of life (reported by participants)
  • Adherence to the intervention based on sessions

    T1: after 12 weeks of intervention

    Quality of life (reported by participants)
  • Adherence to the intervention based on drop-out

    T1: after 12 weeks of intervention

    Quality of life (reported by participants)
  • Change in Twelve Item MS Walking Scale (MSWS-12)

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Walking and mobility
  • Change in Visual Analogue Scale (VAS) (0-10) for balance performance

    T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1

    Walking and mobility

Who could take part

MS (type not specified) · 18 and over · EDSS 2 to 4

Show the full criteria

Inclusion criteria

* All disease courses of MS * Expanded Disability Status Scale (EDSS) 2-4 * Hospital Anxiety and Depression Scale (HADS) \< 10 in the two subset of anxiety and depression * Berg Balance Scale (BBS) > 46 * Mini-Mental State Examination (MMSE) > 24 * At least 1 month without having been treated with rehabilitation * Willingness to sign informed consent

Exclusion criteria

* Visual deficits that could compromise the use of MS-FIT * Relapses in the last 3 months

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

About this trial

In the sponsor's words

To date, despite recent advances in MS care including rehabilitation interventions, many PwMS are unable to access these developments due to limited mobility, fatigue and related issues, and costs associated with travel. Thus, physical activity at home could be a new way to deliver exercises to the patients. Although Pilates did not show any significant advantage over standardized physical therapy in the current literature, it is a good method to promote physical activity, sensorimotor integration and cognitive stimulation. Thus, it could be a treatment option to improve fatigue, balance and walking abilities in PwMS; consequently, Pilates could be suggested by the clinician as a physical activity to be integrated in the daily life. This possibility could be made more feasible using new tools such as those offered by low cost devices. The main MS-FIT project purposes are to provide and to test a tool based on serious game concept of Pilates-inspired exercises for daily use at home, by mixing the entertainment aspects typical of the videogames and the possibility to perform physical activity. The MS-FIT tool does not pursue therapeutic aims as rehabilitation does, but it could have a positive impact on prevention and health in MS. MS-FIT, by using the Microsoft Kinect Motion Controller Xbox or similar to deliver adapted physical activity, offers the possibility to transform the Pilates exercises into a virtual reality game. MS-FIT, through a multicentre approach, would provide: * a feasibility study in order to: * refine the tool for the final customized version to be used in a RCT MS study * assess the tool for PwMS in terms of technology acceptability and satisfaction-to-use * assess the process of recruitment, the adherence to the intervention, the dropout rate and identify potential issues * assess human resources necessary for the RCT * estimate the effect of the intervention and its variance necessary to calculate the appropriate sample size for the RCT * a RCT study in order to evaluate the effect of a physical activity intervention of exercises inspired to Pilates self-managed at home in terms on PwMS

Papers

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History

    1. Started

      Mar 2022

    2. Main results due

      Oct 2023

    3. Finished

      Oct 2023

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