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Multiple SclerosisNCT06028776

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

A study testing MS Ballroom Fitness in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 88 pwMS will be enrolled and equally randomized into an intervention group or a control-waitlist group. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
MS Ballroom Fitness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteDenmark
Study dates
1 Jul 2023to 10 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Aarhus University, Exercise Biology

    Aarhus C, Jutland, 8000

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
MS Ballroom Fitness
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MS Ballroom FitnessBehavioural

    A personalized dance-based concept focusing on balance, walking capacity, and well-being.

Study groups in NCT06028776
Study groupRoleWhat they receive
InterventionExperimentalThis 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.
Receives: Behavioral: MS Ballroom Fitness
ControlNo interventionThis group will continue their habitual living, also including whatever 'usual care' they participate in.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six spot step test (SSST)

    Objective test that measures walking coordination and balance. Unit: seconds.

    Measured: Change from Baseline to 7 weeks

  2. WHO5 wellbeing index

    Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).

    Measured: Change from Baseline to 7 weeks

Secondary outcomes (12)
  1. 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)

    Measured: Change from Baseline to 7 weeks

  2. Functional reach test

    Objective test that measures how far a person can reach with one arm in standing position. Unit: cm.

    Measured: Change from Baseline to 7 weeks

  3. 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.

    Measured: Change from Baseline to 7 weeks

  4. Four square step test (FSST)

    Objective test that measures dynamic stability and co-ordination. Unit: s.

    Measured: Change from Baseline to 7 weeks

  5. 6-minute walk test

    Objective test that measures walking endurance. Unit: meters.

    Measured: Change from Baseline to 7 weeks

  6. 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.

    Measured: Change from Baseline to 7 weeks

  7. Patient determined disease steps

    Questionnaire that measures level of disability in multiple sclerosis. Unit: score (0-8; 0 is better).

    Measured: Change from Baseline to 7 weeks

  8. Multiple Sclerosis Walking Scale

    Questionnaire that measures walking limitations in multiple sclerosis. Unit: score (0-100; 0 is better).

    Measured: Change from Baseline to 7 weeks

  9. 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).

    Measured: Change from Baseline to 7 weeks

  10. Modified fatigue impact scale

    Questionnaire that measures the impact fatigue has on daily life. Unit: score (0-84; 0 is better)

    Measured: Change from Baseline to 7 weeks

  11. Falls-efficacy scale - international

    Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better)

    Measured: Change from Baseline to 7 weeks

  12. Falls

    Number of falls in the past year

    Measured: Change from Baseline to 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start1 Jul 2023
  3. Primary completion30 Jun 2024
  4. Study completion10 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028776
Sponsor's protocol ID
MS_Ballroom_Fit
Status last verified
Dec 2024
First submitted
31 Aug 2023
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: By Danish Law and following GPDR regulations from Aarhus University, we are not allowed to share individual data.

Questions about this trial

What is this clinical trial studying?

A study testing MS Ballroom Fitness in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six spot step test (SSST) (time frame: Change from Baseline to 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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