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

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MS Ballroom Fitness
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aarhus University, Exercise BiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

This group will continue their habitual living, also including whatever 'usual care' they participate in.

Outcomes

Primary Outcome Measures

Six spot step test (SSST)
Objective test that measures walking coordination and balance. Unit: seconds.
WHO5 wellbeing
Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).

Secondary Outcome Measures

Static balance
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)
Functional reach test
Objective test that measures how far a person can reach with one arm in standing position. Unit: cm.
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.
Four square step test
Objective test that measures dynamic stability and co-ordination. Unit: s.
6-minute walk test
Objective test that measures walking endurance. Unit: meters.
Ottawa sitting scale
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.
Patient determined disease steps
Questionnaire that measures level of disability in multiple sclerosis. Unit: score (0-8; 0 is better).
Multiple Sclerosis Walking Scale
Questionnaire that measures walking limitations in multiple sclerosis. Unit: score (0-100; 0 is better).
European Quality of life - 5 Dimensions (EuroQOL5D)
Questionnaire that measures quality of life. Unit: score (0-100; 0 is better).
Modified fatigue impact scale
Questionnaire that measures the impact fatigue has on daily life. Unit: score (0-84; 0 is better)
Falls-efficacy scale - international
Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better)
Falls
Number of falls in the past year

Full Information

First Posted
August 31, 2023
Last Updated
September 14, 2023
Sponsor
University of Aarhus
Collaborators
The Danish MS Society
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1. Study Identification

Unique Protocol Identification Number
NCT06028776
Brief Title
Effects of MS Ballroom Fitness on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
Official Title
MS Ballroom Fitness - Benefits of a Personalized Dance-based Concept on Balance, Walking Capacity, and Well-being in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish MS Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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, balance can be comprehensively assessed by the mini balance evaluation systems test (miniBEST), specifically evaluating dynamic balance, functional mobility, and gait. 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, alongside a long distance 'endurance' walk test (e.g., the 6-minute maximal walk test (6MWT)) that can also help capture motor fatigability. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will continue their habitual living, also including whatever 'usual care' they participate in.
Intervention Type
Behavioral
Intervention Name(s)
MS Ballroom Fitness
Intervention Description
A personalized dance-based concept focusing on balance, walking capacity, and well-being.
Primary Outcome Measure Information:
Title
Six spot step test (SSST)
Description
Objective test that measures walking coordination and balance. Unit: seconds.
Time Frame
Change from Baseline to 7 weeks
Title
WHO5 wellbeing
Description
Questionnaire that measures current mental well-being. Unit: score (0-100; 100 is better).
Time Frame
Change from Baseline to 7 weeks
Secondary Outcome Measure Information:
Title
Static balance
Description
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)
Time Frame
Change from Baseline to 7 weeks
Title
Functional reach test
Description
Objective test that measures how far a person can reach with one arm in standing position. Unit: cm.
Time Frame
Change from Baseline to 7 weeks
Title
Modified functional reach test
Description
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.
Time Frame
Change from Baseline to 7 weeks
Title
Four square step test
Description
Objective test that measures dynamic stability and co-ordination. Unit: s.
Time Frame
Change from Baseline to 7 weeks
Title
6-minute walk test
Description
Objective test that measures walking endurance. Unit: meters.
Time Frame
Change from Baseline to 7 weeks
Title
Ottawa sitting scale
Description
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.
Time Frame
Change from Baseline to 7 weeks
Title
Patient determined disease steps
Description
Questionnaire that measures level of disability in multiple sclerosis. Unit: score (0-8; 0 is better).
Time Frame
Change from Baseline to 7 weeks
Title
Multiple Sclerosis Walking Scale
Description
Questionnaire that measures walking limitations in multiple sclerosis. Unit: score (0-100; 0 is better).
Time Frame
Change from Baseline to 7 weeks
Title
European Quality of life - 5 Dimensions (EuroQOL5D)
Description
Questionnaire that measures quality of life. Unit: score (0-100; 0 is better).
Time Frame
Change from Baseline to 7 weeks
Title
Modified fatigue impact scale
Description
Questionnaire that measures the impact fatigue has on daily life. Unit: score (0-84; 0 is better)
Time Frame
Change from Baseline to 7 weeks
Title
Falls-efficacy scale - international
Description
Questionnaire that measures concerns about falling. Unit: score (16-64; 16 is better)
Time Frame
Change from Baseline to 7 weeks
Title
Falls
Description
Number of falls in the past year
Time Frame
Change from Baseline to 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Hvid
Phone
93508717
Email
lhvid@ph.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Hvid, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University, Exercise Biology
City
Aarhus C
State/Province
Jutland
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Hvid
Phone
93508717
Email
lhvid@ph.au.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
By Danish Law and following GPDR regulations from Aarhus University, we are not allowed to share individual data.

Learn more about this trial

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

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