NCT04011579: MS-FIT

Pilates Training in Multiple Sclerosis

Completed NA Last updated 22 February 2024

What this trial tests

NA trial testing MSFIT in Multiple Sclerosis in 126 participants. Completed in 20 October 2023.

Timeline

15 March 2022

Primary endpoint
20 October 2023

20 October 2023

Quick facts

Lead sponsor	Fondazione Italiana Sclerosi Multipla
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	15 March 2022
Primary completion	20 October 2023
Estimated completion	20 October 2023
Sites	1 location across Italy

Drugs / interventions tested

• MSFIT

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Physical Activity — all drugs for Physical Activity →

Sponsor

Fondazione Italiana Sclerosi Multipla

Who can join

18 and older, any sex, with Multiple Sclerosis or Physical Activity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Internet- and Kinect-Based Multiple Sclerosis Fitness Intervention Training With Pilates Exercises: Development and Usability Study.
   Tacchino A, Ponzio M, Confalonieri P, Leocani L, et al · · 2023 · cited 1× · PMID 37938895 · DOI 10.2196/41371
2. Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.
   Tacchino A, Ponzio M, Confalonieri P, Leocani L, et al · · 2025 · PMID 39899835 · DOI 10.2196/58026