Clinical trial NCT06028776: Effects of MS Ballroom Fitness on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
Official title: MS Ballroom Fitness - Benefits of a Personalized Dance-based Concept on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish MS Society
First posted: 2023-09-08
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief summary: 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 88 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: 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, walking balance/coordination can be assessed by the six spot step test (SSST). Dynamic balance/coordination can be assessed by the four sqaure step test (FSST). Balance can also be assessed by the functional reach test (FRT) as well as the 30-second single leg stance test. Other measures of walking capacity can be assessed by a 'simple' short distance walk test (e.g., the timed 25 foot maximal walk test (T25FWT)) and a long distance 'endurance' walk test (e.g., the 6-minute maximal walk test (6MWT)). 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).

The study sample size was calculated based on unpublished SSST pilot data from n=11 pwMS undergoing 7 weeks of MSB-Fit, corresponding to what was offered in the present study. The estimate (α = 0.05; power = 0.90; control mean post intervention 7.16±1.18 s; MSB-Fit mean post intervention 6.27±1.18 s; dropout rate = 15%) suggested that a total of n=88 pwMS should be enrolled in the present study.

Eligibility criteria: 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)

Primary outcomes:
measure: Six spot step test (SSST)
timeFrame: Change from Baseline to 7 weeks
measure: WHO5 wellbeing index
timeFrame: Change from Baseline to 7 weeks
Secondary outcomes:
measure: Static balance
timeFrame: Change from Baseline to 7 weeks
measure: Functional reach test
timeFrame: Change from Baseline to 7 weeks
measure: Modified functional reach test
timeFrame: Change from Baseline to 7 weeks
measure: Four square step test (FSST)
timeFrame: Change from Baseline to 7 weeks
measure: 6-minute walk test
timeFrame: Change from Baseline to 7 weeks
measure: Trunk Impairment Scale 2.0
timeFrame: Change from Baseline to 7 weeks
measure: Patient determined disease steps
timeFrame: Change from Baseline to 7 weeks
measure: Multiple Sclerosis Walking Scale
timeFrame: Change from Baseline to 7 weeks
measure: Health-related quality of life visual analogue scale (HR-QoL VAS)
timeFrame: Change from Baseline to 7 weeks
measure: Modified fatigue impact scale
timeFrame: Change from Baseline to 7 weeks
measure: Falls-efficacy scale - international
timeFrame: Change from Baseline to 7 weeks
measure: Falls
timeFrame: Change from Baseline to 7 weeks
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University, Exercise Biology
state: Jutland
Study officials:
affiliation: University of Aarhus
name: Lars Hvid, PhD
role: PRINCIPAL_INVESTIGATOR
References: