Effects of MS Ballroom Fitness on Balance, Walking Capacity, and Well-being in Multiple Sclerosis

Study Overview
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Brief Summary
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The goal of the present study is to evaluate the effects of a dance-based concept entitled MS Ballroom Fitness (developed in Denmark by PT Elisabeth Dalsgaard) in persons with multiple sclerosis (pwMS). A total of 66 pwMS will be enrolled and equally randomized into an intervention group or a control-waitlist group. Those in the intervention group will undertake 7 weeks of MS Ballroom Fitness, with 2 sessions per week. The investigators assume that balance, walking capacity as well as well-being will be improved.

Detailed Description
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Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system (CNS) causing demyelination of axons within the CNS as well as loss of axons and neurons. While a wide range of symptoms potentially develops due to the pathology of MS, lower extremity motor function appears preferentially affected. It is therefore not surprising that substantial impairments in balance and walking capacity have been reported in pwMS, based on both subjective (patient perspectives) and objective assessments. This is problematic as balance and walking capacity are rated among the most important bodily functions, and furthermore associated with mental well-being and quality of life. In pwMS, balance can be comprehensively assessed by the mini balance evaluation systems test (miniBEST), specifically evaluating dynamic balance, functional mobility, and gait. As for walking capacity, this can be comprehensively assessed by using a 'simple' short distance walk test (e.g., the timed 25 foot maximal walk test (T25FWT)), a 'complex' short distance walk test (e.g., the six spot step test (SSST)) that involves challenging components of coordination and dynamic balance, alongside a long distance 'endurance' walk test (e.g., the 6-minute maximal walk test (6MWT)) that can also help capture motor fatigability. In addition to these, the 12-item MS Walking Scale (MSWS-12) are commonly used to assess the patient-reported impact of MS on different aspects of walking ability. Different modalities of exercise therapy have been shown effective in counteracting the deterioration of balance and walking capacity observed in pwMS, with improvements reported across all the tests outlined above. Interestingly, dance (including mixed modalities with a predominant dance-based content) appear particularly potent in terms of targeting impairments in balance AND walking capacity. Whilst some pilot/exploratory studies involving pwMS exist, the summarized evidence appear sparse and contain three major limitations. First, the majority of pwMS studies are small exploratory non-controlled studies lacking sample size calculations. Second, none of the identified dance studies provide a personalized approach, i.e., by designing interventions that embrace the needs and physical functional level of each participant. Third, none of the identified dance studies have assessed whether dance-induced adaptations in balance and walking capacity are accompanied by - or even translates into - improvements in mental well-being and quality of life. Physiotherapist Elisabeth Dalsgaard has developed a dance-based concept entitled MS Ballroom FitnessTM (abbreviated MSB-Fit) with a specific focus on joy of life and inclusion. It is specifically adapted to pwMS, having three difficulty levels that correspond to three overall disability categories (sitting, standing, and walking pwMS).

Official Title
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MS Ballroom Fitness - Benefits of a Personalized Dance-based Concept on Balance, Walking Capacity, and Well-being in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: MS Ballroom Fitness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-reported MS diagnosis patient-determined disease steps (PDDS) ≤ 7 (7 correspond to use a wheelchair for most daily activities) able to independently attend the testing Exclusion Criteria: self-reported comorbidities excluding participation in the intervention substantial cognitive impairments hindering participation recent fractures (6 months) critical physical impairments hindering participation in the described training study participation in structured exercise therapy (including dancing) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will use a classic RCT approach, although participants randomized into the control group will be offered the intervention afterwards (hence, termed control-waitlist group).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will be offered 2 weekly sessions (45-60 min) of MS Ballroom Fitness for a period of 7 weeks. All other 'usual care' are allowed. | Behavioral: MS Ballroom Fitness<br>* A personalized dance-based concept focusing on balance, walking capacity, and well-being.<br>|
| No Intervention: Control<br>This group will continue their habitual living, also including whatever 'usual care' they participate in. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six spot step test (SSST) | Objective test that measures walking coordination and balance. Unit: seconds. | Change from Baseline to 7 weeks | 
| WHO5 wellbeing | Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better). | Change from Baseline to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static balance | Objective test that measures static balance (total score based on 5 different tests; 10s parallel foot stand, 10s semi-parallel foot stand, 10s tandem foot stand, 20s right leg foot stand, 20s left leg foot stand). Unit: seconds (0-70s; 70s is better) | Change from Baseline to 7 weeks | 
| Functional reach test | Objective test that measures how far a person can reach with one arm in standing position. Unit: cm. | Change from Baseline to 7 weeks | 
| Modified functional reach test | Objective test that measures how far a person can reach (forward, left, right) with one arm in sitting position. Unit: cm. NB: This test is used for wheel-chair users only. | Change from Baseline to 7 weeks | 
| Four square step test | Objective test that measures dynamic stability and co-ordination. Unit: s. | Change from Baseline to 7 weeks | 
| 6-minute walk test | Objective test that measures walking endurance. Unit: meters. | Change from Baseline to 7 weeks | 
| Ottawa sitting scale | Rater-evaluated test that measures the level of trunk impairments and sitting balance. Unit: score (0-24; 24 is better). NB: This test is used for wheel-chair users only. | Change from Baseline to 7 weeks | 
| Patient determined disease steps | Questionnaire that measures level of disability in multiple sclerosis. Unit: score (0-8; 0 is better). | Change from Baseline to 7 weeks | 
| Multiple Sclerosis Walking Scale | Questionnaire that measures walking limitations in multiple sclerosis. Unit: score (0-100; 0 is better). | Change from Baseline to 7 weeks | 
| European Quality of life - 5 Dimensions (EuroQOL5D) | Questionnaire that measures quality of life. Unit: score (0-100; 0 is better). | Change from Baseline to 7 weeks | 
| Modified fatigue impact scale | Questionnaire that measures the impact fatigue has on daily life. Unit: score (0-84; 0 is better) | Change from Baseline to 7 weeks | 
| Falls-efficacy scale - international | Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better) | Change from Baseline to 7 weeks | 
| Falls | Number of falls in the past year | Change from Baseline to 7 weeks |