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Clinical Trials/NCT05415956
NCT05415956
Completed
Not Applicable

"Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis

University of Aarhus1 site in 1 country60 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Aarhus
Enrollment
60
Locations
1
Primary Endpoint
6-minutes walk test (6MWT)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Deterioration of walking capacity is a common symptom in persons with multiple sclerosis (pwMS), furthermore having a negative influence on well-being. Studies have nevertheless shown that walking exercise therapy can improve walking capacity in pwMS. This may be particularly potent if occurring outdoors due to the varying stimuli it can provide (different surfaces and terrain etc.), and if the intensity and duration is adequate. Furthermore, outdoor walking is (1) suitable as a group intervention facilitating interaction between pwMS and (2) advantageous due to the health benefits offered through the interaction with nature itself. Both these aspects are also relevant for well-being.

Few studies have nevertheless examined the effects of outdoor walking exercise therapy in pwMS. The purpose of the present study is therefore to examine the effects of 7 weeks of moderate-to-high intensity outdoor walking exercise therapy on walking capacity (primary outcome: 6-minute walk test) and well-being in pwMS.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
November 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥ 18 years
  • self-reported clinical MS diagnosis
  • PDDS ≤ 4 (corresponding to preserved walking capacity without assistive devices of at least 10 m)
  • able to independently attend the testing

Exclusion Criteria

  • self-reported comorbidities excluding participation in the intervention
  • recent (6 months retrospective) fractures, amputation or other critical physical impairments that eliminates participation in the described training study
  • participation in structured exercise therapy (including walking) for the past 3 months (≥ 2 session per week of moderate-to-high intensity)

Outcomes

Primary Outcomes

6-minutes walk test (6MWT)

Time Frame: Change from baseline (Pre) to after 7 weeks intervention (Post)

Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance.

Secondary Outcomes

  • 6-minutes walk test (6MWT)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • Timed 25-foot walk test (T25FWT)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • Six spot step test (SSST)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • 12-item multiple sclerosis walking scale (MSWS-12)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • WHO five well-being index (WHO5)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • EuroQoL 5 dimensions 3 levels (EQ5D)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • Modified fatigue impact scale (MFIS)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • Falls-efficacy scale (FES-I)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • Patient-determined disease steps (PDDS)(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))
  • Baecke physical activity questionnaire(Change from baseline (Pre) to 24 weeks follow-up (Follow-up))

Study Sites (1)

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