Outwalk MS - Benefits of Outdoor Walking in Multiple Sclerosis

Study 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.

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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Walking exercise therapy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking exercise therapy<br>7 week intervention group. 6-12 persons per group. 2 sessions per week, 14 sessions in total. Surface: the investigators aim to involve as much forest/gravel trails as possible, with up/down hill walking. Uneven session numbers: warm-up (6 minutes at BORG 10-11), continous walking (starting at 12-20 minutes at BORG 13-14 and progressing to 20-40 minutes at BORG 15-16, adjusted according to the starting level of each participant) and cool-down (approximately 10 minutes at BORG 10-11). Even session numbers: warm-up (6 minutes at BORG 10-11), intermittent walking (starting at 3-4 intervals of 2 minutes at BORG 14-15 and progressing to 4-5 intervals of 2-3 minutes at BORG 16-17; with all intervals being interspersed by 1 minute rest) and cool-down (approximately 10 minutes at BORG 10-11). | Behavioral: Walking exercise therapy<br>* Moderate-to-high intensity walking exercise therapy (7 weeks, 14 session) with progression in duration and intensity.<br>* Other names: Physical exercise;|
| No Intervention: Control/Waitlist<br>7 week control/waitlist group. Continuation of habitual lifestyle during the 7 week intervention period (yet these participants will receive the exact walking exercise therapy afterwards). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minutes walk test (6MWT) | Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minutes walk test (6MWT) | Maximal distance covered in 6 minutes using a 30 meter walkway. Assesses walking endurance. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| Timed 25-foot walk test (T25FWT) | 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). | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| Timed 25-foot walk test (T25FWT) | 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). | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| Six spot step test (SSST) | 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. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| Six spot step test (SSST) | 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. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| 12-item multiple sclerosis walking scale (MSWS-12) | Questionnaire (patient-reported outcome) assessing patient-reported impact of multiple sclerosis on walking ability. Total score range 12-60 (0-100%); lower is better. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| 12-item multiple sclerosis walking scale (MSWS-12) | Questionnaire (patient-reported outcome) assessing patient-reported impact of multiple sclerosis on walking ability. 12 questions. Total score range 12-60 (0-100%); lower is better. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| Modified fatigue impact scale (MFIS) | 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. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| Modified fatigue impact scale (MFIS) | 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. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| Falls-efficacy scale (FES-I) | 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. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| Falls-efficacy scale (FES-I) | 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. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| WHO five well-being index (WHO5) | Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| WHO five well-being index (WHO5) | Questionnaire (patient-reported outcome) assessing patient-reported well-being. 5 questions. Score range 0-25 (0-100%); higher is better. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| EuroQoL 5 dimensions 3 levels (EQ5D) | 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. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| EuroQoL 5 dimensions 3 levels (EQ5D) | 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. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| Baecke physical activity questionnaire | Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. 4 questions. Score range is continuous (0-xx). Higher is better. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| Baecke physical activity questionnaire | Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. 4 questions. Score range is continuous (0-xx). Higher is better. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 
| Patient-determined disease steps (PDDS) | Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS). 9 questions/categories. Each category represents disability level; lower is better. | Change from baseline (Pre) to after 7 weeks intervention (Post) | 
| Patient-determined disease steps (PDDS) | Questionnaire (patient-reported outcome) assessing patient-reported disability in multiple sclerosis (MS). 9 questions/categories. Each category represents disability level; lower is better. | Change from baseline (Pre) to 24 weeks follow-up (Follow-up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Walking