Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilates Training in Multiple Sclerosis (MS-FIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011579
Recruitment Status : Not yet recruiting
First Posted : July 8, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Sclerosi Multipla

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Physical Activity Other: MSFIT Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple Sclerosis Fitness Intervention Training With Pilates Exercises
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MSFIT
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
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.

No Intervention: CTRL
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.



Primary Outcome Measures :
  1. Change in Timed Up & Go (TUG) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    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.


Secondary Outcome Measures :
  1. Change in Timed 25-Foot Walk (T25FW) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.

  2. Change in Ambulation Index (AI) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The AI is a rating scale developed by Hauser et al (1983) to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic and fully active) to 10 (bedridden). The patient is asked to walk a marked 25-foot course as quickly and safely as possible. The examiner records the time and type of assistance (e.g., cane, walker, crutches) needed.

  3. Change in 2-Minutes Walking Test (2WT) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The 2-minute walk test (2WT) is an easy to perform and practical test that has been used in the assessment of patients with a variety of diseases. It simply measures the distance that a patient can walk on a flat, hard surface in a period of 2 minutes.

  4. Change in Technology Acceptance Model (TAM) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The technology acceptance model (TAM) is an information systems theory that models how users come to accept and use a technology. The model suggests that when users are presented with a new technology, a number of factors influence their decision about how and when they will use it, notably: the Perceived usefulness and the Perceived ease-of-use.

  5. Change in Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The CSQ-8 is the most used self-report questionnaires constructed to measure satisfaction with services received by individuals and families. The item score ranges from 1 to 4 and the maximum total score is 32. Higher values mean met needs.

  6. Change in Telehealth Satisfaction Scale (TeSS) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    Evaluation of the level of satisfaction with telehealth from the perspective of clinic patients.The item score ranges from 1 to 4 and the maximum total score is 40. Higher values mean excellent satisfaction.

  7. Adherence to the intervention based on sessions [ Time Frame: T1: after 12 weeks of intervention ]
    Number of sessions actually performed

  8. Adherence to the intervention based on drop-out [ Time Frame: T1: after 12 weeks of intervention ]
    Number of dropout

  9. Change in Twelve Item MS Walking Scale (MSWS-12) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability. The item score ranges from 1 to 5 and the maximum total score is 60. Lower values mean lower disease impact on walking.

  10. Change in Visual Analogue Scale (VAS) (0-10) for balance performance [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    Balance performance subjective evaluation on a scale of 10 points. Subjects have to indicate the self-perceived balance performance in a line ranging from 0 to 10.

  11. Change in Nine-Hole Peg Test (9HPT) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The Nine-Hole Peg Test (9HPT) is a test used to measure finger dexterity in patients with various neurological diagnoses.

  12. Change in Modified Fatigue Impact Scale (MFIS) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    MFIS is a 21-items questionnaire and provides a subjective assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The item score ranges from 0 to 4 and the maximum total score is 84. Lower values mean lower self-perceived effect of fatigue. Physical subtest range from 0 to 36. Cognitive subtest ranges from 0 to 40. Psychosocial subtest ranges from 0 to 8.

  13. Change in Brief International Cognitive Assessment for MS (BICAMS) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The Brief International Cognitive Assessment for MS (BICAMS) battery includes Symbol Digit Modality Test (SDMT) for information processing, Californian Verbal Learning Test (CVLT) for verbal memory, Visuospatial Memory Test (BVMT) for spatial memory. In SDMT subjects have to assign as fast and as accurate as possible the numbers 1-9 to predefined symbols in 90s. In VLMT the examiner reads aloud and consecutively the 15 words to the participant who in return has to recall as many words as possible. This procedure is repeated 5 times. The sum score is the number of correctly recalled words. In BVMT subjects have to encode 6 geometrical figures and memorize their precise location during presentation of 10s. Immediately afterwards, subjects have to draw the memorized figures in the right location. The procedure is repeated 3 times. Depending on figure and exact location accuracy, a scoring from 0 to 2 points for each figure is given. The total recall score is the sum of the three trials.

  14. Change in Patient Global Impression of Change (PGIC) with a 7-points scale [ Time Frame: T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. It has the options "very much improved", "much improved", "minimally improved", "no change", "minimally worsened", "much worsened", and "very much worsened".

  15. Change in Multiple Sclerosis Quality of Life-54 (MSQoL54) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In addition, there are 12 subscales: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. There are also two single-item measures: satisfaction with sexual function and change in health. See the original article describing the development and testing of the MSQOL-54 (Vickrey et al, 1995) for details. Administration forms and scoring instructions can be downloaded.

  16. Change in Psychological Well-Being Scales (PWB) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]

    PWB measures 6 aspects of wellbeing/happiness that respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement.

    Self-acceptance: High scorer: Possesses a positive attitude toward the self; Low scorer: Feels dissatisfied with self.

    Positive relations with others: Higher score: Has warm, satisfying, trusting relationships with others; Lower score: Has few close, trusting relationships with others.

    Autonomy: High scorer: Is self-determining and independent; Low scorer: Is concerned about the expectations and evaluations of others.

    Environmental mastery: High scorer: Has a sense of mastery and competence in managing the environment; Low scorer: Has difficulty managing everyday affairs; Purpose in life: High scorer: Has goals in life and a sense of directedness; Low scorer: Lacks a sense of meaning in life.

    Personal growth: High scorer: Has a continued development feeling; Low scorer: Has a personal stagnation sense.


  17. Change in International Physical Activity Questionnaire (IPAQ) [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]

    IPAQ is a method for physical activity assessment of time spent in several domains. In particular 5 domains are considered: JOB-RELATED; TRANSPORTATION; HOUSEWORK, HOUSE MAINTENANCE, AND CARING FOR FAMILY; RECREATION, SPORT, AND LEISURE-TIME; TIME SPENT SITTING.

    Three levels of physical activity are proposed:

    Low: Those individuals who not meet criteria for categories 2 or 3.

    Moderate:

    • 3 or more days of vigorous activity of at least 20 minutes per day
    • 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day
    • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 (metabolic equivalent)MET-min/week.

    High:

    • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/ week OR
    • 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week.

  18. Change in Minnesota Leisure-Time Physical Activity Questionnaire [ Time Frame: T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1 ]
    Assessment of physical activity in terms of total energy expenditure. The results were expressed in a weekly value [kcal/week] after dividing the calcu- lated 6-month energy expenditure by 26 weeks. The following ranges of activity intensity were used: low [< 4 MET], medium [4 - < 6 MET] and high [≥ 6 MET], where 1 MET equals the resting metabolic rate, which is approximately 3.5 ml oxygen kg-1 body weight per min-1.

  19. Correlation between genetic polymorphisms and response to protocol [ Time Frame: T0: before intervention ]
    Blood samples at baseline to genotype the subjects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011579


Contacts
Layout table for location contacts
Contact: Andrea Tacchino 3491403917 andrea.tacchino@aism.it

Sponsors and Collaborators
Fondazione Italiana Sclerosi Multipla
Investigators
Layout table for investigator information
Principal Investigator: Giampaolo Brichetto Italian Multiple Sclerosis Foundation
Layout table for additonal information
Responsible Party: Fondazione Italiana Sclerosi Multipla
ClinicalTrials.gov Identifier: NCT04011579    
Other Study ID Numbers: FISM 2019MSFIT
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Italiana Sclerosi Multipla:
Physical activity
Pilates
Fitness
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases