Pilates Training in Multiple Sclerosis

NCT04011579 | Completed

• 1 other identifier: FISM 2019MSFIT
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; Physical Activity

Keywords

Physical activity; Pilates; Fitness

Outcome Measures

Primary Outcomes (1)

• Change in Timed Up & Go (TUG)

  The Timed "Up and Go" Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.

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

Secondary Outcomes (19)

• Change in Timed 25-Foot Walk (T25FW)

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

• Change in Ambulation Index (AI)

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

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

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

• 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

Study Arms (2)

MSFIT

EXPERIMENTAL

The MSFIT group will self-manage Pilates exercises at-home through a tool based on XBox Kinect for 12 weeks, performing at least 3 sessions/week for a total of 30 minutes of exercises for each session(also distributed during the day with a minimum slot of 10 minutes). No rehabilitative interventions except sphincter and speech rehabilitation and psychological support, are admitted for the 12 weeks of participation to the project and the following 6 weeks before Follow-up evaluations (a total of 18 weeks). The execution of unspecific physical activities, if not already practiced, will be suggested to the participants.

Other: MSFIT

CTRL

NO INTERVENTION

No rehabilitative interventions except sphincter and speech rehabilitation and psychological support, are admitted for the 12 weeks of participation to the project and the following 6 weeks before Follow-up evaluations (a total of 18 weeks). The execution of unspecific physical activities, if not already practiced, will be suggested to the participants.

Interventions

MSFIT OTHER

MSFIT, by using the Microsoft Kinect Motion Controller Xbox to deliver adapted physical activity, offers the possibility to transform the Pilates exercises into a virtual reality game. Each exercise is implemented with different levels of difficulty in order to allow the adaptation to the capacities of the user.

MSFIT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Italiana Sclerosi Multipla: lead

Study Sites (1)

Italian Multiple Sclerosis Foundation

Genoa, 16149, Italy

Location

Related Publications (1)

• Tacchino A, Ponzio M, Confalonieri P, Leocani L, Inglese M, Centonze D, Cocco E, Gallo P, Paolicelli D, Rovaris M, Sabattini L, Tedeschi G, Prosperini L, Patti F, Sessa E, Pedrazzoli E, Battaglia MA, Brichetto G. Effect of an Internet-Based Pilates Telerehabilitation Intervention in People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 3;14:e58026. doi: 10.2196/58026.

  PMID: 39899835 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Giampaolo Brichetto

  Italian Multiple Sclerosis Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: July 8, 2019
• Study Start: March 15, 2022
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)