Clinical Trials Directory

Trials / Completed

CompletedNCT06028776

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
95 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMS Ballroom FitnessA personalized dance-based concept focusing on balance, walking capacity, and well-being.

Timeline

Start date
2023-07-01
Primary completion
2024-06-30
Completion
2024-09-10
First posted
2023-09-08
Last updated
2025-03-19

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06028776. Inclusion in this directory is not an endorsement.