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

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT06028776
Collaborator
The Danish MS Society (Other)
66
1
2
5.7
11.5

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MS Ballroom Fitness
N/A

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 [1]. While a wide range of symptoms potentially develops due to the pathology of MS, lower extremity motor function appears preferentially affected [2, 3]. It is therefore not surprising that substantial impairments in balance and walking capacity have been reported in pwMS, based on both subjective (patient perspectives) [4-6] and objective assessments [7-11]. This is problematic as balance and walking capacity are rated among the most important bodily functions [6, 12], and furthermore associated with mental well-being and quality of life [13-15].

In pwMS, balance can be comprehensively assessed by the mini balance evaluation systems test (miniBEST), specifically evaluating dynamic balance, functional mobility, and gait [16-18]. 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 [19, 20], alongside a long distance 'endurance' walk test (e.g., the 6-minute maximal walk test (6MWT)) [21, 22] that can also help capture motor fatigability [23, 24]. 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 [25].

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 [6, 17, 26, 27]. Interestingly, dance (including mixed modalities with a predominant dance-based content) appear particularly potent in terms of targeting impairments in balance AND walking capacity [28]. Whilst some pilot/exploratory studies involving pwMS exist [29-32], 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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 (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
MS Ballroom Fitness - Benefits of a Personalized Dance-based Concept on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 22, 2023
Anticipated Study Completion Date :
Dec 22, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Six spot step test (SSST) [Change from Baseline to 7 weeks]

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

  2. WHO5 wellbeing [Change from Baseline to 7 weeks]

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

Secondary Outcome Measures

  1. Static balance [Change from Baseline to 7 weeks]

    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)

  2. Functional reach test [Change from Baseline to 7 weeks]

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

  3. Modified functional reach test [Change from Baseline to 7 weeks]

    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.

  4. Four square step test [Change from Baseline to 7 weeks]

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

  5. 6-minute walk test [Change from Baseline to 7 weeks]

    Objective test that measures walking endurance. Unit: meters.

  6. Ottawa sitting scale [Change from Baseline to 7 weeks]

    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.

  7. Patient determined disease steps [Change from Baseline to 7 weeks]

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

  8. Multiple Sclerosis Walking Scale [Change from Baseline to 7 weeks]

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

  9. European Quality of life - 5 Dimensions (EuroQOL5D) [Change from Baseline to 7 weeks]

    Questionnaire that measures quality of life.

  10. Modified fatigue impact scale [Change from Baseline to 7 weeks]

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

  11. Falls-efficacy scale - international [Change from Baseline to 7 weeks]

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

  12. Falls [Change from Baseline to 7 weeks]

    Number of falls in the past year

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aarhus University, Exercise Biology Aarhus C Jutland Denmark 8000

Sponsors and Collaborators

  • University of Aarhus
  • The Danish MS Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT06028776
Other Study ID Numbers:
  • MS_Ballroom_Fit
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023