Multiple Sclerosis
Conditions
Keywords
Exercise, Walking
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.
Interventions
BEHAVIORALWalking exercise therapy
Moderate-to-high intensity walking exercise therapy (7 weeks, 14 session) with progression in duration and intensity.
Sponsors
The Danish MS Society
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-minutes walk test (6MWT) | 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
| Measure | Time frame | Description |
|---|---|---|
| EuroQoL 5 dimensions 3 levels (EQ5D) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Questionnaire (patient-reported outcome) assessing patient-reported quality of life. VAS scale score range 0-100%; higher is better. 5 domains, scored separately, score range 1-3; lower is better. |
| Baecke physical activity questionnaire | Change from baseline (Pre) to after 7 weeks intervention (Post) | Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. 4 questions. Score range is continuous (0-xx). Higher is better. |
| 6-minutes walk test (6MWT) | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance. |
| Timed 25-foot walk test (T25FWT) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Time used to complete a 25-foot (= 7.62 meters) walk test. Two trials are given. Assesses horizontal walking propulsion/acceleration (i.e. walking speed). |
| WHO five well-being index (WHO5) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better. |
| 12-item multiple sclerosis walking scale (MSWS-12) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Questionnaire (patient-reported outcome) assessing patient-reported impact of multiple sclerosis on walking ability. Total score range 12-60 (0-100%); lower is better. |
| Modified fatigue impact scale (MFIS) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Questionnaire (patient-reported outcome) assessing patient-reported perceived fatigue impact. 21 questions. Total score range 0-84; lower is better. Physical subscale score range (9 questions) 0-36; lower is better. Cognitive subscale score range (10 questions) 0-40; lower is better. Psychosocial subscale score range (2 questions) 0-8; lower is better. |
| Falls-efficacy scale (FES-I) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Questionnaire (patient-reported outcome) assessing concerns of falling along with history of falls. 7 questions. Total score range 0-28; lower is better. History of falls: one year recall. |
| Patient-determined disease steps (PDDS) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS). 9 questions/categories. Each category represents disability level; lower is better. |
| Six spot step test (SSST) | Change from baseline (Pre) to after 7 weeks intervention (Post) | Time used to complete the SSST (5 wooden blocks must be pushed/kicked outside their initial position). Four trials are given, two with each foot being used to push/kick the wooden blocks. Assesses horizontal coordination and dynamic balance during walking. |
Countries
Denmark
Outcome results
None listed