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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: MS Ballroom Fitness

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Jutland
    • Aarhus C, Jutland, Denmark, 8000
      • Aarhus University, Exercise Biology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; A personalized dance-based concept focusing on balance, walking capacity, and well-being.
No Intervention: Control; This group will continue their habitual living, also including whatever 'usual care' they participate in.

What is the study measuring?

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 index	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
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
6-minute walk test	Objective test that measures walking endurance. Unit: meters.	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
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
Static balance	Objective test that measures static balance (total score based on 2 different tests; 20s right leg foot stand, 20s left leg foot stand). Unit: seconds (0-40s; 40s is better)	Change from Baseline to 7 weeks
Four square step test (FSST)	Objective test that measures dynamic stability and co-ordination. Unit: s.	Change from Baseline to 7 weeks
Health-related quality of life visual analogue scale (HR-QoL VAS)	Questionnaire/scale that measures quality of life. Unit: score (0-100; 0 is better).	Change from Baseline to 7 weeks
Trunk Impairment Scale 2.0	Rater-evaluated test that measures static and dynamic sitting balance as well as co-ordination of trunk movement. Unit: score (0-23; 23 is better). NB: This test is used for wheel-chair users only.	Change from Baseline to 7 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: The Danish MS Society
• Investigators: Principal Investigator: Lars Hvid, PhD, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): September 10, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MS_Ballroom_Fit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: By Danish Law and following GPDR regulations from Aarhus University, we are not allowed to share individual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No