Clinical trial NCT05415956: "Outwalk MS" - Benefits of Outdoor Walking in Multiple Sclerosis
Official title: "Outwalk MS" - Benefits of Outdoor Walking Exercise Therapy on Walking Capacity and Well-being in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Walking
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish MS Society
First posted: 2022-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 7 week randomized controlled trial; intervention group and waitlist/control group.

The investigators will perform a cluster randomization (computer generated random numbers) according to cities across Denmark (when 4-12 pwMS are interested and eligible).

Waitlist/control group will be offered the same outdoor walking exercise therapy after the initial 7 weeks.

24 weeks after the walking exercise intervention, a follow-up test will be carried out as well.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: 6-minutes walk test (6MWT)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
Secondary outcomes:
measure: 6-minutes walk test (6MWT)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: Timed 25-foot walk test (T25FWT)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: Timed 25-foot walk test (T25FWT)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: Six spot step test (SSST)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: Six spot step test (SSST)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: 12-item multiple sclerosis walking scale (MSWS-12)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: 12-item multiple sclerosis walking scale (MSWS-12)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: Modified fatigue impact scale (MFIS)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: Modified fatigue impact scale (MFIS)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: Falls-efficacy scale (FES-I)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: Falls-efficacy scale (FES-I)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: WHO five well-being index (WHO5)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: WHO five well-being index (WHO5)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: EuroQoL 5 dimensions 3 levels (EQ5D)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: EuroQoL 5 dimensions 3 levels (EQ5D)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: Baecke physical activity questionnaire
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: Baecke physical activity questionnaire
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
measure: Patient-determined disease steps (PDDS)
timeFrame: Change from baseline (Pre) to after 7 weeks intervention (Post)
measure: Patient-determined disease steps (PDDS)
timeFrame: Change from baseline (Pre) to 24 weeks follow-up (Follow-up)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Health, Exercise Biology
state: Jutland
Study officials:
affiliation: Aarhus University, Department of Public Health, Exercise Biology
name: Lars G Hvid, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: