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

NCT06028776 | Completed

• 1 other identifier: MS_Ballroom_Fit
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Six spot step test (SSST)

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

  Change from Baseline to 7 weeks

• WHO5 wellbeing index

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

  Change from Baseline to 7 weeks

Secondary Outcomes (12)

• Static balance

  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

• Four square step test (FSST)

  Change from Baseline to 7 weeks

• 6-minute walk test

  Change from Baseline to 7 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

MS Ballroom Fitness BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish MS Society: collaborator

Study Sites (1)

Aarhus University, Exercise Biology

Aarhus C, Jutland, 8000, Denmark

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lars Hvid, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 10, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)