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临床试验/NCT06028776
NCT06028776已完成不适用

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

University of Aarhus2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
2
主要终点
Six spot step test (SSST)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Six spot step test (SSST)

时间窗: Change from Baseline to 7 weeks

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

WHO5 wellbeing index

时间窗: Change from Baseline to 7 weeks

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

次要结局

  • Static balance(Change from Baseline to 7 weeks)
  • Four square step test (FSST)(Change from Baseline to 7 weeks)
  • Functional reach test(Change from Baseline to 7 weeks)
  • Modified functional reach test(Change from Baseline to 7 weeks)
  • 6-minute walk test(Change from Baseline to 7 weeks)
  • Patient determined disease steps(Change from Baseline to 7 weeks)
  • Trunk Impairment Scale 2.0(Change from Baseline to 7 weeks)
  • Multiple Sclerosis Walking Scale(Change from Baseline to 7 weeks)
  • Health-related quality of life visual analogue scale (HR-QoL VAS)(Change from Baseline to 7 weeks)
  • Modified fatigue impact scale(Change from Baseline to 7 weeks)
  • Falls-efficacy scale - international(Change from Baseline to 7 weeks)
  • Falls(Change from Baseline to 7 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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