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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028776
• Other study ID #: MS_Ballroom_Fit
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: August 2023
• Source: University of Aarhus
• Contact: Lars Hvid
• Phone: 93508717
• Email: lhvid[@]ph.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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, 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• MS Ballroom Fitness
A personalized dance-based concept focusing on balance, walking capacity, and well-being.

Locations

Country	Name	City	State
Denmark	Aarhus University, Exercise Biology	Aarhus C	Jutland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish MS Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six spot step test (SSST)	Objective test that measures walking coordination and balance. Unit: seconds.	Change from Baseline to 7 weeks
Primary	WHO5 wellbeing	Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).	Change from Baseline to 7 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Four square step test	Objective test that measures dynamic stability and co-ordination. Unit: s.	Change from Baseline to 7 weeks
Secondary	6-minute walk test	Objective test that measures walking endurance. Unit: meters.	Change from Baseline to 7 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Falls-efficacy scale - international	Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better)	Change from Baseline to 7 weeks
Secondary	Falls	Number of falls in the past year	Change from Baseline to 7 weeks